Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, June 19, 2015

11 CHARGED IN CONSPIRACY TO MANUFACTURE, DISTRIBUTE COUNTERFEIT 5-HOUR ENERGY DRINK

FROM:  U.S. JUSTICE DEPARTMENT
Friday, June 19, 2015
Eleven Defendants Charged in Nationwide Conspiracy to Manufacture and Distribute Counterfeit 5-Hour ENERGY Drink
Defendants Sold Millions of Bottles of Counterfeit 5-Hour ENERGY Drink

U.S. Attorney Melinda Haag of the Northern District of California, Special Agent in Charge David J. Johnson of the FBI’s San Francisco Field Office and Special Agent in Charge Lisa L. Malinowsk of the U.S. Food and Drug Administration’s (FDA) Los Angeles Field Office of Criminal Investigations announced today that 10 people were arrested after being charged with conspiracy to traffic in counterfeit goods, conspiracy to commit criminal copyright infringement and conspiracy to introduce misbranded food into interstate commerce.  The defendants were arrested on charges stemming from the illegal distribution and counterfeit of the liquid dietary supplement 5-Hour ENERGY.  One further defendant was not arrested but remains subject to an arrest warrant.

According to the indictment that was unsealed yesterday, all 11 defendants were involved in the illegal repackaging and eventual counterfeiting of 5-Hour ENERGY.  The supplement is owned by a group of entities referred to in the indictment as Living Essentials, which manufactured all 5-Hour ENERGY at factories in Wabash, Indiana.  Living Essentials has registered and owns all 5-Hour ENERGY trademarks and a copyright, including the “5-Hour ENERGY” name and various graphical elements of the product’s labeling and packaging.  The 5-Hour ENERGY trademarks and copyrighted material are displayed on every bottle of 5-Hour ENERGY and display boxes.  Living Essentials does not provide licenses to any individual or entity to manufacture 5-Hour ENERGY.

According to the indictment, defendants Joseph Shayota and Adriana Shayota, his wife, through their company Baja Exporting LLC, agreed with Living Essentials to distribute 5-Hour ENERGY in Mexico.  Living Essentials manufactured the liquid 5-Hour ENERGY product and provided Spanish-language labeling and display boxes to Baja Exporting.  Living Essentials additionally provided Baja a complete product package under the agreement that the 5-Hour ENERGY with Spanish-language labeling was only to be distributed by Baja in Mexico.  Nevertheless, according to the indictment, rather than distributing authentic 5-Hour ENERGY with Spanish-language labeling in Mexico, the defendants attempted instead to divert the product and to sell it in the United States at a higher price.  After initial efforts to sell the product failed because of the Spanish-language labeling and display boxes, the defendants replaced the labeling and display boxes with counterfeit labels and boxes designed to imitate Living Essentials’ packaging in the United States.  The defendants repackaged over 350,000 bottles of 5-Hour ENERGY and sold them in the United States at a price that was 15 percent lower than what Living Essentials charged for authentic United States 5-Hour ENERGY.  By December 2011, Joseph and Adriana Shayota had sold off Baja’s remaining stock of the repackaged/relabeled 5-Hour ENERGY.

Also according to the indictment, by early 2012, the defendants had moved into counterfeiting the entire 5-Hour ENERGY product.  The defendants manufactured the counterfeit 5-Hour ENERGY liquid at an unsanitary facility using untrained day workers.  The defendants mixed unregulated ingredients in plastic vats while attempting to mimic the real 5-Hour ENERGY products.

From December 2011 through October 2012, the defendants allegedly ordered more than seven million counterfeit label sleeves and hundreds of thousands of counterfeit display boxes and placed false lot and expiration codes on the bottles and boxes.  The defendants often changed the lot and expiration codes on the counterfeit bottles and boxes to parallel the valid codes being used on the authentic product.

The indictment further alleges that the defendants travelled to Guadalajara, Mexico, and hired manufacturers for the blank plastic bottles and plastic bottle caps imprinted with the Living Essentials-trademarked “Running Man” logo.  They also purchased equipment, including a steam tunnel machine, to shrink-wrap the counterfeit 5-Hour ENERGY labels on the counterfeit bottles and an inkjet printer to place false lot numbers and expiration dates on the bottoms of the counterfeit bottles.

The defendants also allegedly used code words in purchase orders and invoices for counterfeit 5-Hour ENERGY.  For example, defendants Walid Jamil, Juan Romero and Leslie Roman referred to the counterfeit 5-Hour ENERGY liquid contents as “michelada,” “juice blend” and “spices.”

In addition, the indictment alleges that from May 2012 to October 2012, Midwest Wholesale Distributors, a company owned by Jamil, distributed more than four million bottles of counterfeit 5-Hour ENERGY into commercial channels throughout the United States.  Midwest sold approximately 508,032 counterfeit 5-Hour ENERGY bottles to Baja Exporting and 3,521,232 counterfeit 5-Hour ENERGY bottles to the Dan-Dee Company, which was owned by defendants Kevin Attiq and Raid Attiq.  A partial list of retail vendors and wholesale distributors to whom the alleged counterfeit product was sold is attached.

“The defendants’ alleged conduct demonstrates a complete disregard of the health and safety of consumers,” said U.S. Attorney Haag.  “My office will continue to vigorously prosecute those individuals who place greed over the well-being of the community by distributing counterfeit dietary products.”

“The business of trafficking in counterfeit merchandise harms victims in many ways," said Special Agent in Charge Johnson.  “Intellectual property crimes are anything but victimless.  Intellectual property crimes can destroy jobs, suppress innovation and jeopardize the public health and safety.  In this complex case, the suspects allegedly produced a product to counterfeit a popular dietary supplement that was ultimately consumed by the public.  The FBI and its partners will continue to bring these types of criminals to justice.”

“U.S. consumers rely on FDA oversight of foods to ensure that they are safe and wholesome,” said Special Agent in Charge Malinowski.  “Criminals who produce and sell counterfeit and misbranded dietary supplements put the public health at risk by utilizing unknown and unregulated ingredients that could put the consumer in danger of serious illness or death.  This alleged counterfeit operation was especially egregious as the investigation revealed this product was sold, distributed and placed on the shelves of numerous retailers throughout the United States.  We will continue to investigate violators of our laws and work to bring them to justice.”

The 11 indicted defendants, all of whom are charged with conspiracy to traffic in counterfeit goods, conspiracy to commit criminal copyright infringement and conspiracy to introduce misbranded food into interstate commerce, include:

Joseph Shayota, 63, of El Cajon, California. Shayota was arrested yesterday at his residence.  He made an initial appearance before the Honorable U.S. Magistrate Judge Nita L. Stormes in the Southern District of California, who ordered him released on $250,000 bond and to surrender his passport.  Shayota’s next scheduled court appearance will be on July 9, 2015, at 1:30 p.m., before the Honorable U.S. Magistrate Judge Howard R. Lloyd to schedule further proceedings in U.S. District Court in San Jose, California.

Adriana Shayota, 44, also of El Cajon. Shayota was arrested yesterday at her residence.  She made an initial appearance before U.S. Magistrate Judge Stormes in the Southern District of California, who ordered her released on $100,000 bond and to surrender her passport.  Shayota’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Justin Shayota, 32, of Troy, Michigan. Shayota was arrested yesterday at his residence. He made an initial appearance before the Honorable U.S. Magistrate Judge David T. Grand in the Eastern District of Michigan, who ordered him released on a $10,000 unsecured bond and to surrender his passport by noon tomorrow. Shayota’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Walid Jamil, aka Wally Jamil, 65, also of Troy. Jamil self-surrendered to the FBI yesterday. He made an initial appearance before U.S. Magistrate Judge Grand in the Eastern District of Michigan, who ordered him released on a $10,000 unsecured bond and to surrender his passport by noon tomorrow. Jamil’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before the U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Raid Jamil, aka Brian Jamil, 46, of West Bloomfield, Michigan. Jamil surrendered to the FBI yesterday. He made an initial appearance before U.S. Magistrate Judge Grand in the Eastern District of Michigan, who ordered him released on a $10,000 unsecured bond and to surrender his passport by noon tomorrow. Jamil’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Kevin Attiq, 51, of El Cajon. Attiq was arrested yesterday at his residence. He made an initial appearance before U.S. Magistrate Judge Stormes in the Southern District of California, who released him on $100,000 bond and to surrender his passport. Attiq’s next scheduled court appearance is on July 9, 2015, before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Fadi Attiq, 57, of El Cajon. Attiq was arrested yesterday at his residence. He made an initial appearance before U.S. Magistrate Judge Stormes in the Southern District of California, who released him on $100,000 bond and to surrender his passport. Attiq’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Leslie Roman, 61, of Rancho Cucamonga, California. Roman was arrested yesterday at his residence. He made an initial appearance before the Honorable U.S. Magistrate Judge David T. Bristow in the Central District of California, who released him on $50,000 bond after he surrendered his passport. Roman’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Mario Ramirez, 55, of San Diego.Ramirez was arrested yesterday at his residence. He made an initial appearance before U.S. Magistrate Judge Stormes in the Southern District of California, who released him on $100,000 cash via cashier’s check and ordered him to surrender his passport. Ramirez’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Camilo Ramirez, 30, of San Diego. Ramirez was arrested yesterday at his residence.  He made an initial appearance before U.S. Magistrate Judge Stormes in the Southern District of California, who released him on $100,000 cash via cashier’s check and ordered him to surrender his passport.  Ramirez’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Juan Romero, 68, of Upland, California. An arrest warrant remains outstanding for Romero.

An indictment merely alleges that crimes have been committed, and all defendants are presumed innocent until proven guilty beyond a reasonable doubt.  If convicted, the defendants face the following maximum statutory penalties:

For each count of conspiracy to traffic in counterfeit goods: 10 years imprisonment, a $2 million fine, three years of supervised release and a $100 special assessment.

For each count of conspiracy to commit criminal copyright infringement: five years imprisonment, a $250,000 fine, three years of supervised release and a $100 special assessment.

For each count of conspiracy to introduce misbranded food into interstate commerce: five years imprisonment, a $250,000 fine, three years of supervised release and a $100 special assessment.

However, any sentence following conviction would be imposed by the court after consideration of the U.S. Sentencing Guidelines and the federal statute governing the imposition of a sentence.

Assistant U.S. Attorneys Matt Parrella and Susan Knight of the Northern District of California are prosecuting the case with the assistance of Elise Etter.  The prosecution is the result of an investigation by the FBI and the FDA’s Office of Criminal Investigations.

Sunday, June 7, 2015

U.S. FDA PROGRAM TO EXPEDITE REVIEW FOR CERTAIN FOOD IMPORTERS

FROM:  U.S. FOOD AND DRUG ADMINISTRATION
New FDA Program Will Benefit Both Importers and Consumers
June 4, 2015

The U.S. Food and Drug Administration is establishing a voluntary, fee-based program for the expedited review and importation of foods into the United States from importers with a proven food safety track record. The FDA is publishing a draft guidance for industry to explain how this new program will work.

The Voluntary Qualified Importer Program (VQIP) will benefit both industry and consumers.

Importers with a robust system of supply-chain management will receive expedited entry for imported foods that are in the program.
Consumer protections are strengthened by enabling the FDA to focus its resources on food imports that are more likely to present a potential risk to public health.

The FDA Food Safety Modernization Act, signed into law in January 2011, provides the FDA with new authorities to ensure that foods imported into the United States meet the same safety standards as those set for domestically produced foods.

In addition to establishing mandatory standards for importers of food under the Foreign Supplier Verification Program (FSVP), FSMA also requires the FDA to establish VQIP for importers who achieve and maintain a high level of control over the safety and security of their supply chains.  This control includes importation of food from facilities that have been certified as following appropriate food safety practices under FDA’s Accredited Third-Party Certification regulations, also required by FSMA.

FDA is issuing a notice in the Federal Register announcing the availability of a draft guidance entitled “Draft Guidance for Industry on the Voluntary Qualified Importer Program for Food Importers and Guidelines in Consideration of the Burden of the VQIP Fee Amounts on Small Business.”

The draft guidance document outlines VQIP provisions and provides information on:

the benefits VQIP  importers can expect to receive;
eligibility criteria;
instructions for completing a VQIP application;
conditions that could result in revocation of VQIP participation; and
criteria for VQIP reinstatement following revocation.
In addition, the Notice of Availability provides a preliminary estimate of the fee for the program and requests comment on whether and how this amount would be a burden for small businesses.

There will be a public comment period of 75 days on the draft guidance and the guidelines related to the burden of fees on small businesses. After comments are considered and the guidance finalized, the program is expected to be open for applications in January 2018 to allow enough time for a facility to be certified under FDA’s Accredited Third Party Certification program.

Wednesday, April 29, 2015

FDA APPROVES FIRST GENERIC VERSIONS OF DRUG APPROVED TO TREAT SCHIZOPHRENIA, BIPOLAR DISORDER

FROM:  U.S. FOOD AND DRUG ADMINISTRATION

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration today approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.

Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.

Schizophrenia is a chronic, severe and disabling brain disorder. About one percent of Americans have this illness. Typically, symptoms are first seen in adults younger than 30 years of age. Symptoms of schizophrenia include hearing voices, believing other people are reading their minds or controlling thoughts and being suspicious or withdrawn.

Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

All atypical antipsychotics contain a Boxed Warning alerting health care professionals about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.

Wednesday, March 25, 2015

FDA ASKS "ARE SOME COSMETICS PROMISING TOO MUCH?"

FROM:  FOOD AND DRUG ADMINISTRATION

Americans spend a lot of money on creams, lotions and other cosmetics that promise to improve their skin, hair, and even eyelashes.
But sometimes those promises go too far.

The Food and Drug Administration (FDA) warns cosmetics companies when they make claims about their products that classify them as drugs, not cosmetics. FDA has issued warning letters citing drug claims associated with topical skin care, hair care, and eyelash/eyebrow preparations, noted on both product labeling and Web sites. Some examples of the drug claims cited are acne treatment, dandruff treatment and hair restoration.

These letters state that the products are being marketed with drug claims—indicating that they are intended to treat or prevent disease, or change the body’s structure or functions. The agency tells companies that they need to remove any drug claims from their products’ labeling or seek FDA approval to market these products as drugs.

“Consumers need to know that these drug claims have not been proven to FDA when they are making a decision to purchase one of these products,” says Linda M. Katz, M.D., MPH, director of FDA’s Office of Cosmetics and Colors. “These products must be evaluated by FDA as drugs before the companies can make claims about changing the skin or treating disease.”

Some of the drug claims have included promises to increase production of collagen and elastin, resulting in skin that is more elastic and firmer, with fewer wrinkles.

Some get even more specific, such as claims that products reduce inflammation, regenerate cells, prevent facial muscle contractions, boost activity of genes, or give you the same results as injections or surgery. Others promise to treat medical conditions, such as acne, rosacea, eczema, and psoriasis.

Wednesday, March 4, 2015

SEAFOOD COMPANY OWNER SENT TO PRISON FOR DEALING IN ILLEGAL OYSTERS

FROM:  U.S. JUSTICE DEPARTMENT I
Monday, March 2, 2015
Delaware Seafood Wholesaler and Company Fined and Owner Sentenced to 26 Months in Prison for Illegally Trafficking in Oysters

Mark Bryan, 59, of New Market, Maryland, and his Delaware-based seafood wholesale business, Harbor House Seafood, were sentenced on Friday in federal court in Camden, New Jersey, for trafficking in illegally possessed oysters, creating false health and safety records, and conspiracy charges.

Bryan was sentenced to serve 26 months in prison followed by three years of supervised release. Bryan was also ordered to pay a $62,500 fine and to pay New Jersey $140,000 for the restoration of oyster beds in Delaware Bay.  Harbor House was ordered to pay a $250,000 fine and was sentenced to five years of probation.  Friday’s sentences, in addition to the previous sentencing of Bryan’s co-conspirators and suppliers, brings the total fines and forfeitures in this matter to over $625,000, along with $194,000 of restoration costs..

Bryan and Harbor House were convicted in 2012 of multiple felony crimes related to dealings in illegal oysters from 2004 to 2007.  The evidence showed that for more than four years, Bryan conspired with New Jersey oystermen Thomas Reeves and Todd Reeves to cover up the Reeves’ overharvest of oysters from the Delaware Bay.  Bryan, through his company, Harbor House Seafood, purchased the illegal oysters from the Reeves, then assisted in covering up the Reeves’ overharvest by maintaining double-books, providing federal agents with false records, and by falsifying his FDA-mandated health and safety logs.  The jury saw numerous instances of late-night faxes between Bryan and the Reeves which were used to coordinate their conspiracy and hide their wrong-doing from investigators. Bryan was also shown to have purchased illegal oysters from oyster harvester Kenneth Bailey of New Jersey.  During the course of his crimes, Bryan moved, purchased and sold over $1.2 million worth of illegal oysters.

The Reeves and Bailey were previously sentenced on Feb. 11, 2015, to 26 months, 16 months, and 12 months in prison, respectively, for their roles.

“The defendants’ actions provided a market for dishonest oystermen who were willing to place natural resources at risk in the name of profit,” said Assistant Attorney General John C. Cruden of the Department of Justice’s Environment and Natural Resources Division.  “Today’s sentences send the message that those who knowingly deal in illegal natural resources will be held accountable.”

“Today's sentence underscores the value that state partnerships add to NOAA Office of Law Enforcement’s ability to complete its mission,” said Assistant Director Logan Gregory for NOAA Fisheries Office of Law Enforcement.  “In this case, our partnership with New Jersey Division of Fish and Wildlife was crucial in protecting the oyster resource in New Jersey and leveling the playing field across multiple industry sectors throughout the mid-Atlantic Region.”

The Lacey Act prohibits creating or submitting false records for fish or wildlife moving in interstate commerce and also prohibits trafficking in fish or wildlife known to be illegally taken or possessed.  The FDA and state health agencies require that oyster purchasers and sellers maintain accurate records of the amounts and locations of oyster harvest for all oysters they buy and sell in order to protect public health and minimize the impact of any oyster-borne outbreak of disease.

The case was investigated by the NOAA Office of Law Enforcement and the New Jersey Department of Environmental Protection’s Division of Fish and Wildlife.  The case was prosecuted by Assistant Chief Wayne D. Hettenbach and Trial Attorney Patrick M. Duggan of the Environment and Natural Resources Division’s Environmental Crimes Section, with assistance from Assistant U.S. Attorney Matthew T. Smith of the U.S. Attorney’s Office for the District of New Jersey.

Tuesday, January 20, 2015

DOJ ANNOUNCES COURT INJUNCTION AGAINST MEDICAL LASER MANUFACTURER

FROM:  U.S. JUSTICE DEPARTMENT 
Friday, January 16, 2015
Federal Court Issues Preliminary Injunction Against South Dakota Medical laser Manufacturer

A federal court has barred a Rapid City, South Dakota, company and its president from further manufacturing and distributing its laser devices, which they marketed to treat a variety of medical conditions and diseases, the Justice Department announced today.

U.S. District Court Chief Judge Jeffrey L. Viken for the District of South Dakota entered the preliminary injunction on Wednesday against Robert “Larry” Lytle and his businesses, QLasers PMA, 2035 PMA, and 2035 INC., in an action filed by the Justice Department to enforce provisions of the federal Food, Drug, and Cosmetic Act (FDCA).  The court’s order prohibiting the manufacture and distribution of the QLaser devices also applies to Lytle’s business affiliates and franchisees.

Last October, the Justice Department and the U.S. Attorney’s Office for the District of South Dakota filed a civil complaint for injunctive relief against Lytle and his businesses, alleging that they have been violating the FDCA by nationally marketing Lytle’s laser devices for the treatment of more than 200 different diseases and medical disorders without clearance or approval from the U.S. Food and Drug Administration (FDA).  The preliminary injunction entered on Wednesday takes effect immediately and will remain in force while the government’s case seeking a permanent injunction proceeds to final judgment.

Judge Viken found, based on what he called an “extensive and well developed record,” that Lytle and his various businesses “have shown no intent to discontinue their activities and voluntarily comply with the FDCA.  “The injunction bars the defendants from continuing to market and distribute any medical devices until they receive written permission from the FDA to do so.

Lytle, whom the court noted was a dentist in Rapid City until his license to practice dentistry was permanently revoked by the South Dakota Board of Dentistry in 1998, markets the devices by soliciting purchasers to join his “private membership associations” or “PMAs” before purchasing his lasers.  As the court explained, however, “Hiding behind a curtain of private membership associations, 2035 PMA and QLaser PMA, does not shield Mr. Lytle from the authority of the FDCA or the jurisdiction of the court.”

“With the entry of this preliminary injunction, we have taken another step toward ensuring that only medical devices that have been shown to be safe and effective are placed in the hands of the American consumer,” said Acting Assistant Attorney General Joyce R. Branda for the Justice Department’s Civil Division.  “Everyone who deals in products that affect people’s health must comply with the FDCA.”

According to court documents filed in the case, the defendants have been distributing the QLaser devices with labeling that contains false and misleading claims, touting their use in treating such serious conditions as cancer, HIV/AIDS, venereal disease and diabetes.  Although two of his laser devices were FDA-cleared for providing temporary relief of pain associated with osteoarthritis of the hand, none of the devices has been cleared or approved to treat any other medical conditions.  The government alleges that not only are there no published clinical studies to support the use of Lytle’s lasers to treat other serious medical conditions, but that in fact, using the devices according to the device’s labeling could be dangerous to health.  The court’s order finds that the United States is substantially likely to succeed on the merits on this claim and the others within the government’s complaint.

“The preliminary injunction granted should provide consumers a renewed sense of confidence,” said U.S. Attorney Brendan V. Johnson for the District of South Dakota.  “This action is crucial to prevent the company from continuing to operate on the periphery of the law, and potentially jeopardize the health and safety of its consumers.”

The FDA referred this enforcement action to the Department of Justice.  The government’s case is being litigated by Trial Attorney Ross S. Goldstein of the Civil Division’s Consumer Protection Branch, with assistance from the U.S. Attorney’s Office for the District of South Dakota and the FDA’s Office of Chief Counsel.

Saturday, December 20, 2014

FDA APPROVES VIEKIRA PAK FOR TREATMENT OF HEPATITIS C

FROM: U.S. FOOD AND DRUG ADMINISTRATION 
FDA approves Viekira Pak to treat hepatitis C

The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis.

Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis).

“The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.”

Viekira Pak is the fourth drug product approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni (ledipasvir and sofosbuvir) in October 2014.

Viekira Pak’s efficacy was evaluated in six clinical trials enrolling 2,308 participants with chronic HCV infection with and without cirrhosis. In different trials, participants were randomly assigned to receive Viekira Pak or placebo (sugar pill); Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks.

The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured. Results from multiple populations, including those considered difficult to treat, showed 91 to 100 percent of participants who received Viekira Pak at the recommended dosing achieved SVR. The recommended dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily.

The most common side effects reported in clinical trial participants were feeling tired, itching, feeling weak or lack of energy, nausea and trouble sleeping.

Viekira Pak is the eleventh new drug product with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Viekira Pak was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

Viekira Pak is marketed by AbbVie Inc., based in North Chicago, Illinois. Olysio is marketed by Raritan, New Jersey-based Janssen Pharmaceuticals. Sovaldi and Harvoni are marketed by Gilead Sciences, based in Foster City, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Wednesday, November 26, 2014

U.S. ACCUSES SANDWICH CO. OF DISTRIBUTING FOOD MADE IN INSANITARY CONDITIONS

FROM:  U.S. JUSTICE DEPARTMENT  
Friday, November 21, 2014
United States Files Enforcement Action Against Michigan Sandwich Company and Co-Owner to Stop Distribution of Adulterated Products

A civil complaint was filed in federal court in Michigan against Scotty’s Incorporated of Detroit and its co-owner and manager, Sandra Jackson, to prevent the distribution of adulterated sandwiches, the Department of Justice announced today.

According to the complaint, Scotty’s Incorporated, which does business as Bruce Enterprises and Bruce’s Fresh Products, prepares and distributes ready-to-eat (RTE) sandwiches, including RTE tuna sandwiches.  The complaint alleges that the company’s sandwiches are manufactured in insanitary conditions, and that the company’s procedures are inadequate to ensure the safety of its products.  Moreover, the company has failed to implement a written Hazard Analysis and Critical Control Point (HACCP) plan for handling seafood and minimizing the potential for harmful contamination in the company’s RTE tuna sandwiches.  The Justice Department filed the injunction action in the Eastern District of Michigan at the request of the U.S. Food and Drug Administration (FDA).

“Seafood poses well-known risks when it is transported from ship to shore, but these risks can be effectively mitigated if companies handling seafood take proper precautions,” said Acting Assistant Attorney General Joyce R. Branda of the Justice Department’s Civil Division.  “The Department of Justice will take all appropriate measures to protect the safety of the seafood consumers eat.”

According to the complaint, the FDA has performed five inspections of the defendants’ facility since 2006 and documented insanitary practices and/or seafood HACCP violations every time.  These inspections revealed that the company’s RTE sandwiches are adulterated within the meaning of the Food, Drug, and Cosmetic Act because they are prepared, packed or held under insanitary conditions in which they may have become contaminated with filth or rendered injurious to health.  The complaint alleges, for example, that since 2006, the company was repeatedly told to develop a written HACCP plan recognizing the inherent risks of toxin formation in tuna and enumerating plans to take corrective action when tuna is not properly handled.

Tuna that is not chilled rapidly or stored at sufficiently lower temperatures is at increased risk for the formation of scombrotoxin.  The toxin can be adequately controlled when tuna is chilled after death and maintained at a cold temperature throughout storage and distribution.  In the event that the tuna is not properly maintained, scombrotoxin readily forms and cannot be removed or destroyed through subsequent washing, freezing or cooking of the tuna.  Consumption of fish containing high levels of scombrotoxin may cause scombrotoxin poisoning, the symptoms of which may include burning sensations in the mouth or throat, dizziness, nausea, vomiting, headaches, diarrhea, rashes, hives, a drop in blood pressure, constriction of the air passage, heart palpitations and respiratory distress.

According to the complaint, the FDA’s most recent inspection was conducted between January 14 and February 6.  At the inspection, according to the complaint, the FDA found that the defendants failed to have and implement an HACCP plan for food safety hazards reasonably likely to occur.  There were also no sanitation control records documenting the safety of, among other things, water used at the facility; the cleanliness of surfaces, utensils and equipment coming into contact with food; maintenance of hand-sanitizing machines and bathrooms; exclusion of pests from the facility; and control of employee health conditions such as the wearing of jewelry, hair nets or beard covers.

The government is represented by Trial Attorney Dan Baeza of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Peter Caplan of the Eastern District of Michigan, with the assistance of Assistant Chief Counsel for Enforcement Christopher Fanelli of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.

Saturday, August 30, 2014

FDA COMPLETES REVIEW OF HOW AGENCY EVALUATES HARMFUL CHEMICALS IN PRODUCTS

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

FDA Takes Steps to Strengthen Program to Assess the Safety of Chemicals in Foods, Other Products

August 28, 2014

The U.S. Food and Drug Administration has completed a review of how the agency evaluates the harmful effects of chemicals in foods, cosmetics, dietary supplements, animal food/feed and veterinary drugs. Based on the findings, the agency is taking steps to strengthen internal processes.

The chemical safety assessment review is the first of three planned strategic reviews being conducted under the direction of the FDA’s Office of Foods and Veterinary Medicine (OFVM). The other two focus on nutrition and microbiological laboratory programs.

The FDA conducted the chemical safety assessment review in order to ensure that the agency is making the most effective and efficient use of its chemical safety resources. The review focused on the scientific capacity and management of the program’s multiple elements across the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). Initiated in 2012, the review included interviews of current and former FDA employees involved in all aspects of the agency’s chemical safety assessment program, as well as senior managers from other U.S. government agencies experienced in chemical safety assessment, and five listening sessions conducted by CFSAN with internal and external stakeholders on OFVM’s overall chemical safety assessment program. In addition, four outside consultants, all of whom are considered experts in the field, and who had previously held senior management positions dealing with chemical safety assessment in the Federal government, met with OFVM and senior CFSAN managers to discuss the interview and listening session reports. Based on this discussion and their review of the interview and listening session reports, each consultant also made his or her own written recommendations for OFVM’s chemical safety program.

Working groups were formed in CFSAN and CVM to review all the reports and consultant recommendations. The issues and recommendations identified in the workgroup reports fall into three overarching categories (Science, Communication and Collaboration, and Training and Expertise).


Among the review’s most significant outcomes: the centers, led by CFSAN, will develop a process for updating FDA’s Toxicological Principles for the Safety Assessment of Food Ingredients (also called the “Redbook”), so that it reflects current science. Additionally, the centers will jointly develop a process to ensure consistency of methodologies used for safety and risk assessments within and across offices at CFSAN, and between CFSAN and CVM.

Saturday, August 16, 2014

FDA APPROVES AVASTIN FOR TREATMENT IN SOME PATIENTS WITH CERVICAL CANCER

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer

The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.

Cervical cancer grows in the tissues of the lower part of the uterus known as the cervix. It commonly occurs when human papillomaviruses (HPV), a virus that spreads through sexual contact, cause cells to become cancerous. Although there are two licensed vaccines available to prevent many types of HPV that can cause cervical cancer, the National Cancer Institute estimates that 12,360 American women will be diagnosed with cervical cancer and 4,020 will die from the disease in 2014.

Avastin works by interfering with the blood vessels that fuel the development of cancerous cells. The new indication for cervical cancer is approved for use in combination with chemotherapy drugs paclitaxel and cisplatin or in combination with paclitaxel and topotecan.

“Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is also the first biologic agent approved for patients with late-stage cervical cancer and was approved in less than four months under the FDA’s priority review program, demonstrating the agency’s commitment to making promising therapies available to patients faster.”

The FDA reviewed Avastin for treatment of patients with cervical cancer under its priority review program because the drug demonstrated the potential to be a significant improvement in safety or effectiveness over available therapy in the treatment of a serious condition. Priority review provides an expedited review of a drug’s application.

The safety and effectiveness of Avastin for treatment of patients with cervical cancer was evaluated in a clinical study involving 452 participants with persistent, recurrent, or late-stage disease. Participants were randomly assigned to receive paclitaxel and cisplatin with or without Avastin or paclitaxel and topotecan with or without Avastin. Results showed an increase in overall survival to 16.8 months in participants who received chemotherapy in combination with Avastin as compared to 12.9 months for those receiving chemotherapy alone.

The most common side effects associated with use of Avastin in patients with cervical cancer include fatigue, decreased appetite, high blood pressure (hypertension), increased glucose in the blood (hyperglycemia), decreased magnesium in the blood (hypomagnesemia), urinary tract infection, headache and decreased weight. Perforations of the gastrointestinal tract and abnormal openings between the gastrointestinal tract and vagina (enterovaginal fistula) also were observed in Avastin-treated patients.

Avastin is marketed by South San Francisco, California-based Genentech, a member of the Roche Group.

Wednesday, August 13, 2014

COMPLAINT FILED AGAINST MICHIGAN CHEESE FACTORY FOR DISTRIBUTING ADULTERATED CHEESE PRODUCTS

FROM:  U.S. JUSTICE DEPARTMENT 
Friday, August 8, 2014
United States Files Enforcement Action Against Michigan Cheese Company and Owners to Stop Distribution of Adulterated Cheese Products

A civil complaint was filed today in federal court in Michigan against S. Serra Cheese Company of Clinton Township, Michigan, and its owners, Stefano and Fina Serra, to prevent the distribution of adulterated cheese, announced Assistant Attorney General Stuart F. Delery of the Justice Department’s Civil Division.

S. Serra Cheese Company manufactures and distributes several varieties of Italian cheeses, such as ricotta, provolone, mozzarella and primo sale.  The complaint alleges that the company’s Italian cheeses are manufactured in insanitary conditions, and that the company’s procedures are inadequate to ensure the safety of its products.  The department filed the injunction action in the Eastern District of Michigan at the request of the U.S. Food and Drug Administration (FDA).

“The presence of potentially harmful pathogens in food and processing facilities poses a serious risk to the public health,” said Assistant Attorney General Delery.  “The Department of Justice will continue to bring enforcement actions against food manufacturers who do not follow the necessary procedures to comply with food safety laws.”

According to the complaint, two FDA inspections performed in 2013 revealed that the company’s cheese is adulterated within the meaning of the Food, Drug and Cosmetic Act because it is prepared, packed or held under insanitary conditions in which it may have become contaminated with filth or rendered injurious to health.  The complaint alleges, for example, that the company repeatedly failed to reduce the risk of contamination from two potentially dangerous types of bacteria: Escherichia coli (E. coli) and Listeria innocua (L. innocua).

Although the strains of E. coli found in cheese samples collected from the company’s facility were n on-pathogenic, their presence indicates that the facility is insanitary and contaminated with filth.  In addition, t he presence of L. innocua indicates insanitary conditions and a work environment that could support the growth of L. monocytogenes, an organism that poses a life-threatening health hazard because it is the causal agent for the disease listeriosis, a serious encephalitic disease.  The presence of L. innocua in the company’s facility demonstrates the potential for the presence of L. monocytogenes in the same processing environment.

According to the complaint, the FDA’s most recent inspection in November 2013 revealed insanitary conditions, including the presence of generic, non-pathogenic E. coli and L. innocua and the absence of effective monitoring and sanitation controls in accordance with the current Good Manufacturing Practice requirements for food under federal law.  For example, cleaning and sanitizing operations for utensils and equipment were not performed in a manner that protects against contamination of food and food contact surfaces.

FDA previously inspected the facility in January 2013.  According to the complaint, at that time, FDA inspectors discovered a number of Good Manufacturing Practice deficiencies.  For example, FDA inspectors noted that the facility was not constructed in such a manner as to allow floors to be adequately cleaned and to be kept clean and in good repair.  The FDA inspectors also observed that the company failed to store raw materials in a manner that protects against contamination.

The government is represented by Trial Attorney Dan Baeza of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Peter Caplan for the Eastern District of Michigan, with the assistance of Assistant Chief Counsel for Enforcement Christopher Fanelli of the Food and Drug Division, Office of General Counsel, Department of Health and Human Services.

A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.

Friday, July 25, 2014

AN EXTENDED-RELEASE OXYCODONE WITH ABUSE-DETERRENT PROPERTIES APPROVED BY FDA

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
FDA approves new extended-release oxycodone with abuse-deterrent properties
July 23, 2014

Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the product’s abuse-deterrent properties consistentwith the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.

Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose. Targiniq ER can still be abused, including when taken orally (by mouth), which is currently the most common way oxycodone is abused. It is important to note that taking too much Targiniq ER for purposes of abuse or by accident, can cause an overdose that can result in death.

"The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.,” said Sharon Hertz, M.D., deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain.”

Targiniq ER is not approved, and should not be used, for as-needed pain relief. Given Targiniq ER’s risks for abuse, misuse and addiction, it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management.

The safety and effectiveness of Targiniq ER was evaluated in a clinical trial of 601 people with chronic low back pain. The safety database supporting approval included treatment of more than 3,000 people with Targiniq ER. Data from in vitro (in a laboratory) and in vivo (testing with people) abuse liability studies demonstrated the abuse deterrent features of Targiniq ER as they relate to certain types of abuse (snorting, injecting). The most common side effects of Targiniq ER are nausea and vomiting.

The FDA is requiring postmarketing studies of Targiniq ER, to assess the serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long term use beyond 12 weeks. The FDA is also requiring postmarketing studies to further assess the effects of the abuse-deterrent features on the risk for abuse of Targiniq ER.

In addition, Targiniq ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to health care professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/LA opioids.

Targiniq ER is manufactured by Stamford-based Purdue Pharma L.P.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Thursday, July 10, 2014

FDA APPROVES MEDTRONIC COREVALVE SYSTEM

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
Medtronic CoreValve System - P130021/S002

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Medtronic CoreValve System
PMA Applicant: Medtronic CoreValve LLC
Address: Medtronic CoreValve LLC, 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: June 12, 2014
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf13/P130021S002a.pdf

What is it? The Medtronic CoreValve System (often referred to as the CoreValve) consists of a catheter-based artificial aortic heart valve and accessories used to implant the valve without open-heart surgery. The valve is made of pig tissue attached to a flexible, self-expanding, nickel-titanium frame for support.

How does it work? The CoreValve is compressed and placed on the end of a tube-like device called a delivery catheter. It is then inserted through the femoral artery in the leg. If the femoral arteries are not suitable, the valve can also be inserted through other arteries or through the aorta. The catheter is pushed through the blood vessels until it reaches the diseased aortic valve. The valve is then released from the catheter, it expands on its own, and anchors to the diseased valve. The CoreValve functions the same as a normal valve, helping the blood flow properly by opening and closing like a door to force the blood to flow in the correct direction.

When is it used? The CoreValve is used in patients whose own aortic heart valve is diseased due to calcium build up, which causes the valve to narrow (aortic stenosis) and restricts blood flow through the valve. As the heart works harder to pump enough blood through the smaller opening, the heart eventually becomes weak. This can lead to symptoms and life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest. Once symptoms of severe aortic stenosis occur, over half of the patients die within two years if the diseased valve is not replaced.

The CoreValve should only be used in patients who cannot undergo, or are at high risk for open heart surgery as determined by their heart team (a cardiologist and surgeon).

What will it accomplish? The CoreValve can help correct the blood flow problem associated with aortic stenosis in patients who need open-heart surgery to replace the diseased valve, but the surgical procedure is highly risky, or too risky. In the U.S. clinical trial, the CoreValve was shown to be reasonably safe and effective for those patients without the need for open-heart surgery. However, implanting the CoreValve also carries the risk of serious complications such as death, stroke, acute kidney injury, heart attack, bleeding, complications with the arteries used to insert the valve, and the need for a permanent pacemaker. For some patients with coexisting conditions or diseases, the risks may be especially high. Patients should discuss with their doctors the benefits and risks of this device.

When should it not be used? The CoreValve should not be used in patients who:

have an infection in the heart or elsewhere.
have an artificial (mechanical) aortic valve.
cannot tolerate blood thinning medicines.
have sensitivity to Nitinol (Titanium or Nickel) or to fluid used during the procedure to   see internal structures (contrast media).
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.

Wednesday, June 4, 2014

FDA REPORTS ON MAMMOGRAPHY QUALITY STANDARDS ACT

MQSA National Statistics





















FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
MQSA National Statistics
In this section of the MQSA Scorecard, we present the most commonly requested national statistics regarding the MQSA program. These statistics are updated on the first of each month.

Certified facilities, as of October 1, 2013 8,691
Certification statistics, as of June 1, 2014  
  Total certified facilities / Total accredited units 8,714 / 13,523
  Certified facilities with FFDM2 units / Accredited FFDM units 8,154 / 12,790
FY 2014 inspection statistics, as of June 1, 2014  
  Facilities inspected 5,323
  Total units at inspected facilities 7,947
  Percent of inspections where the highest noncompliance was a:  
    Level 1 violation 0.3%
  Level 2 violation 11.4%
  Level 3 violation 1.4%
  Percent of inspections with no violation 86.9%
Total annual mammography procedures reported, as of June 1, 20141 38,747,608
1 This number is an aggregate of the total number of procedures performed annually as reported by facilities to their accreditation bodies. Facilities are asked to disclose this information at their initial accreditation, and then at the time of their re-accreditation, which takes place once every three years. FDA began collecting these data in 1998. The aggregate does not reflect the current number of procedures performed at these facilities, but only the numbers reported by them during the three-year period prior to the current date. We have aggregated only the numbers reported by certified, non-Veterans Administration facilities.
2 FFDM - Full Field Digital Mammography unit.

Sunday, June 1, 2014

GENERIC CELEBREX APPROVED BY FDA FOR ARTHRITIS, OSTEOARTHRITIS

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
FDA approves first generic versions of celecoxib
May 30, 2014
Release

The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.

Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.

“It is important for patients to have access to affordable treatment options for chronic conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards.”

Celecoxib is a Non-Steroidal Anti-Inflammatory Drug (NSAID). All NSAIDs have a Boxed Warning in their prescribing information (label) to alert health care professionals and patients about the risk of heart attack or stroke that can lead to death. This chance increases for people with heart disease or risk factors for it, such as high blood pressure, or taking NSAIDs for long periods of time. The Boxed Warning also highlights the risk of serious, potential life-threatening gastrointestinal (GI) bleeding that has been associated with use of NSAIDs.

In the clinical trials for Celebrex, the most commonly reported adverse reactions in patients taking the drug for arthritis were abdominal pain, diarrhea, indigestion (dyspepsia), flatulence, swelling of the feet or legs (peripheral edema), accidental injury, dizziness, inflammation of the throat (pharyngitis), runny nose (rhinitis), swollen nasal passages, (sinusitis), upper respiratory tract infection, and rash.

Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

Information about the availability of generic celecoxib can be obtained from the companies.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Sunday, May 11, 2014

FDA APPROVES USE OF CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P) AND DEFIBRILLATORS (CRT-D)

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
Medtronic CRT-P and CRT-D Devices - P010015/S205 and P010031/S381

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Products Name: This approval is for the following Cardiac Resynchronization Therapy Pacemakers (CRT-P) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) devices:Medtronic, Inc.
Address: 8200 Coral Sea Street
Mounds View, MN 55112
Approval Date: April 10, 2014
Approval Letters: http://www.accessdata.fda.gov/ cdrh_docs/pdf/P100015S205a.pdf and http://www.accessdata.fda.gov/cdrh_docs/
pdf/P010031S381a.pdf
Consulta® CRT-P Model C4TR01
Syncra® CRT-P Model C2TR01

Consulta CRT-D Model D224TRK and D204TRM
Maximo II CRT-D Model D284TRK and D264TRM
Concerto II CRT-D Model D274TRK
Protecta XT CRT-D Model D314TRG and D314TRM
Protecta CRT-D Model D334TRG and D334TRM
Viva XT CRT-D Model DTBA1D1 and DTBA1D4
Viva S CRT-D Model DTBB1D1 and Model DTBB1D4
Brava CRT-D Model DTBC1D1 and DTBC1D4

What is it?

A Cardiac Resynchronization Therapy disclaimer icon  (CRT) device is a special pacemaker designed to treat symptoms of heart failure by sending specially timed electrical impulses to improve the timing, or resynchronize pumping action of the heart's lower chambers (right and left ventricles). This improved timing can help control symptoms from heart failure.

There are two types of implantable CRT devices: one that is only a pacemaker (CRT-P) and the other that is a combination of a pacemaker and defibrillator (CRT-D). Defibrillators can shock the heart rhythm back to normal should dangerously fast rhythms occur.

Each CRT device consists of a pulse generator (containing a battery and electronic circuitry) connected to insulated wires called leads that deliver electrical impulses to stimulate the heart. The synchronizing leads include a right ventricular lead (RV) and a left ventricular (LV) lead.

A CRT-D combination pacemaker and defibrillator has added features and ability so it is able to detect and treat dangerously fast heart rhythms. Only some individuals with a damaged heart muscle are likely enough to develop dangerous heart rhythms to need a defibrillator. A physician can determine whether a CRT-P or CRT-D device is most appropriate.

How does it work? Both CRT-P and CRT-D devices resynchronize the heart action by providing electrical impulses to improve timing of the right and left sides of the heart using RV and LV leads. The leads also carry signals from the heart to the device. The timing of the impulses is programmed by the doctor to restore a more natural timing and pumping of the heart muscle which can improve heart failure. The RV leads of CRT-D devices have additional features to deliver high voltage energy to defibrillate the heart should life-threatening, dangerously fast rhythms occur in the ventricles (ventricular arrhythmia) disclaimer icon .

When is it used? CRT-P and CRT-D devices have been approved for many years for patients with poorly synchronized right and left ventricles to improve their heart failure symptoms. Based on the results of a new clinical study called BLOCK HF, FDA is now expanding who is eligible (or “indicated”) for CRT. The new, added patients must have EACH of the following:

MUST have slow or absent ventricular heart beating (heart block) with symptoms that would traditionally require a conventional pacemaker PLUS mild to moderate heart failure symptoms PLUS at least mild heart muscle damage The actual specific indications appear below. After evaluating a patient’s degree of heart damage and heart failure symptoms, a doctor can determine whether they fit the new BLOCK HF indication and would benefit from CRT.
CRT-P Device Indications:

Previously Approved by FDA:

Patients with moderate to severe heart failure symptoms (NYHA Functional Class III and IV) despite stable, optimal heart failure medical therapy
PLUS severe heart damage (cardiac ejection fraction [LVEF] less than or equal to 35%) PLUS electrocardiogram (EKG) signs of poor synchronization of the ventricles

New BLOCK HF Indication:

slow or absent ventricular heart beating (atrioventricular block [AV block] expected to require a high percentage of ventricular pacing that would traditionally require a conventional pacemaker PLUS mild to moderate heart failure symptoms (NYHA Functional Class I, II or III) PLUS at least mild heart muscle damage (cardiac ejection fraction [LVEF] less than or equal to 50%)

NOTE: heart failure medications must be optimized after the device is implanted.
CRT-D Device Indications:

Previously Approved by FDA:

The primary use of a CRT-D system is for automated treatment of life-threatening ventricular arrhythmias. They also provide CRT in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the following heart failure classifications:

Patients with moderate to severe heart failure symptoms (NYHA Functional Class III and IV)

PLUS severe heart damage (cardiac ejection fraction [LVEF] less than or equal to 35%)

PLUS EKG signs of poor synchronization of the ventricles

OR

Patients with mild to moderate heart failure symptoms (NYHA Functional Class II)

PLUS EKG signs of very poor synchronization of the ventricles (Left bundle branch block (LBBB) with a ventricular stimulation time greater than or equal to130 ms)

PLUS severe heart damage (cardiac ejection fraction [LVEF] less than or equal to 30%)

New BLOCK HF CRT-D Indication:
The primary use of a CRT-D system is for automated treatment of life-threatening ventricular arrhythmias. They also provide CRT in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the following heart failure classifications:  slow or absent ventricular heart beating (atrioventricular block [AV block] expected to require a high percentage of ventricular pacing that would traditionally require a conventional pacemaker PLUS mild to moderate heart failure symptoms (NYHA Functional Class I, II or III)

PLUS at least mild heart muscle damage (cardiac ejection fraction [LVEF] less than or equal to 50%)

NOTE: heart failure medications must be optimized after the device is implanted.
What will it accomplish? Based on the results of the BLOCK HF clinical study, when used in the new population as described above, patients may benefit by experiencing less frequent heart failure worsening or need for urgent treatment.
When should it not be used? The contraindications for the CRT-P and CRT-D devices are listed below.

CRT-P Devices:

implantation with another bradycardia device
implantation with an implantable cardioverter defibrillator
There are no known contraindications for the use of pacing as a therapy to control heart rate. The patient’s age and medical condition, however, may determine the particular pacing system, mode of operation, and implant procedure used by the doctor.

automatic adjustment of pacing rate may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate.

Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter.
Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms.

Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance.

Anti-tachycardia pacing (ATP) therapy is contraindicated in patients with an accessory antegrade pathwayCRT-D Devices:

Patients experiencing tachyarrhythmia with transient or reversible causes including, but not limited to, the following: heart attack (acute myocardial infarction), drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia disclaimer icon , or sepsis.

Patients who have a unipolar pacemaker implanted.
Patients with continuous ventricular tachycardia (VT) or ventricular fibrillation (VF).

Patients whose primary disorder is chronic atrial tachyarrhythmia in the absence of VT or VF. (NOTE: This contraindication does not apply to the Maximo II devices).

Friday, April 25, 2014

FDA POINTS OUT SEVERAL TYPES OF TOBACCO PRODUCTS

FROM:  FEDERAL FOOD AND DRUG ADMINISTRATION 
Recognize Tobacco in its Many Forms

Tobacco use is the single largest preventable cause of disease and death in the United States, but can you recognize all the different forms of a tobacco product? The marketplace includes an array of new products, with many looking very different from the traditional tobacco products you may know about.
To attract users, tobacco companies regularly modify their products and introduce novel tobacco products to the market. “Parents should stay updated on the various products available and, discuss the dangers of tobacco use with their children,” says Ii-Lun Chen, M.D., a pediatrician and medical branch chief in the Office of Science at FDA’s Center for Tobacco Products.

The basic components of most cigarettes are tobacco, a filter, and paper wrapping. Although smokers use cigarettes to get nicotine, they are exposed to toxic and cancer-causing chemicals that are created when the cigarette is burned.

Cigars, Little Cigars, Cigarillos

Generally, cigars are cured tobacco wrapped in leaf tobacco or a substance containing tobacco. Cigars vary in size — with smaller sizes sometimes referred to as little cigars or cigarillos. Large cigars can deliver as much as 10 times the nicotine, 2 times more tar, and more than 5 times the carbon monoxide than a filtered cigarette. Although cigarettes with characterizing flavors are illegal, there are products available on the market that look like cigarettes but are labeled as “little cigars,” and some include candy and fruit flavors that appeal to adolescents and youth adults. Cigars also may appeal to youth because they may be less expensive than cigarettes. In addition, young adults may think that cigars are less addictive and present fewer health risks than cigarettes.

Dissolvable Products

In the past, smokeless tobacco products have required spitting or discarding the product remains. There are new tobacco products that are not smoked and are often called “dissolvables.” These products can be more easily concealed as no product disposal is needed. They are sold as lozenges, strips, or sticks, and may look like candy. The advertised appealing flavor and discreet forms of these products may encourage young people to take them up, but the nicotine content can lead to addiction and may also present an accidental poisoning risk for children.


Electronic Cigarettes (Also Referred to as: Vape Pen, e-Hookah, Hookah Pen)

Electronic cigarettes often resemble traditional cigarettes but they use a heat source, usually powered by a battery, to turn “e-liquid,” a liquid that usually contains nicotine from tobacco and flavorings, into an aerosol that is inhaled by the user. The amount of nicotine in the aerosol may vary by brand. Little information about the safety of electronic cigarettes exists.

Traditional Smokeless Tobacco Products

There are two main types of smokeless tobacco that have been traditionally marketed in the United States: chewing tobacco and moist snuff. Chewing tobacco is cured tobacco in the form of loose leaf, plug, or twist. Snuff is finely cut or powdered, cured tobacco that can be dry, moist, or packaged in sachets. Snus is a finely ground moist snuff that can be loose or packaged. Most smokeless tobacco use involves placing the product between the cheek or lip and the gum.

The availability of flavored, lower-nicotine, smokeless tobacco products lacking harsh attributes promoted by manufacturers may allow for experimentation by new users, but may also lead to nicotine addiction and continued use of smokeless or other tobacco products. Over time, smokeless tobacco users may switch from lower-nicotine smokeless tobacco products to products that deliver more nicotine.

Waterpipes (Also Referred to as: Hookah, Shisha, Narghile, Argileh)

Waterpipes (also known as hookah, shisha, narghile, or argileh) are used to smoke specially made tobacco that comes in a variety of flavors like mint, cherry and licorice. Waterpipe smoking delivers the addictive drug nicotine and the smoke from a waterpipe is at least as toxic as, or more toxic than cigarette smoke. In fact, research shows that waterpipe smokers may absorb even more of the harmful components found in cigarette smoke because smoking sessions are longer. A typical one-hour hookah session involves inhaling 100–200 times the volume of smoke from a single cigarette. Waterpipe tobacco flavoring, exotic paraphernalia, and social use at hookah bars have increased its popularity with people who don’t already smoke cigarettes and younger people in the United States.

What FDA Currently Regulates

Currently, FDA regulates the manufacture, marketing and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. However, FDA has recently issued a proposed rule to bring additional products that meet the Tobacco Control Act’s definition of a tobacco product under FDA’s regulatory authority, including electronic cigarettes, some or all cigars, pipe tobacco, dissolvables, and waterpipe tobacco. The proposed rule will be available for public comment for 75 days and FDA encourages the public to submit comments, data, research, or other information related to the proposed rule.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

April 24, 2014

Thursday, April 24, 2014

FDA TOUTS ADULT STEM CELL RESEARCH

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
Adult Stem Cell Research Shows Promise
So What Are Stem Cells?
Why Is FDA Studying These Cells?
What's Being Done?

Scientists sporting white coats and safety gloves are working in a bright Food and Drug Administration (FDA) lab on an incredible project.

They are part of FDA’s MSC Consortium, a large team of FDA scientists studying adult mesenchymal stem cells (MSCs)—cells that could eventually be used to repair, replace, restore or regenerate cells in the body, including those needed for heart and bone repair.

The scientists’ investigational work is unprecedented: Seven labs at FDA's Center for Biologics Evaluation and Research formed the consortium to fill in gaps in knowledge about how stem cells function.

“This research aims to facilitate development of this important class of innovative medical products,” explains Carolyn A. Wilson, Ph.D., associate director for research at the center. “It’s the first time we’ve done anything like this, and it’s proven to be a very useful approach. It’s worked so well because this is a huge, complicated project that requires expertise in many different technologies and methods.”

The research could ultimately be key to the advancement of personalized medicine, the practice in which medical treatment is tailored to the needs of an individual patient. “It’s not science fiction,” says Steven R. Bauer, Ph.D., chief of the Cellular and Tissue Therapy Branch in FDA’s Office of Cellular Tissue and Gene Therapies. “For me, regenerative medicine is the most exciting part of what we regulate in our office.”

So What Are Stem Cells?
There are two basic kinds of stem cells that are currently useful in the field of regenerative medicine: multipotent and pluripotent stem cells. Multipotent stem cells are generally taken from adults and can divide and develop into many different cell types. Pluripotent stem cells can develop into any type of cell in the body. Both types could divide to replenish cells damaged by injury, illness or normal wear. When stem cells divide, the new cells can either remain stem cells or develop into a new type of cell with a more specific function.
Two types of pluripotent stem cells exist: human embryonic stem cells and induced pluripotent stem cells, which are created by reprogramming adult cells that had already changed into a mature type of cell.

FDA’s MSC Consortium is not studying stem cells taken from embryos. “We’re looking at a particular kind of multipotent adult stem cell—the MSC—which is being used in a lot of regenerative medicine clinical trials,” adds Bauer.

The group is currently studying eight unique cell lines, each acquired from commercial sources and sourced to one of eight distinct, adult donors. (Males and females age 22 to 47 donated stem cells from bone marrow.)

The cells under study are multipotent: “They can differentiate (mature into) at least three cell types: bone, fat and cartilage, primarily,” Bauer explains. “They can also differentiate into nerve cells, liver cells and a kind of cell called ‘stroma’ that is in the bone marrow and supports blood forming cells. Then, for investigational clinical uses, they’ve been used for repairing hearts, repairing bone and repairing cartilage.”

Why Is FDA Studying These Cells?
In addition to differentiating into a variety of replacement cell types, MSCs can limit a patient’s immune response. So they can potentially be taken from one human donor and placed into a different recipient with less possibility of rejection.

But growing stem cells and making sure they are safe and effective is challenging, which is one reason why stem-cell based clinical trials have not yet resulted in a marketed product.

“The major challenge is that cells are much more complex than traditional products that FDA regulates. And they have the ability to respond to their environment,” Bauer explains. “Taking them out of the body and manufacturing them—that is, growing large numbers of them—or isolating them can change their biology. And it can change the way they behave if they are put back into the patient.”

For instance, if cells are manufactured in large quantities outside their natural environment, they may become ineffective or develop harmful characteristics. For example, they can produce tumors, severe immune reactions or growth of unwanted tissue. So FDA is trying to develop methods that would predict with more certainty how manufactured or isolated adult stem cells will behave in patients.

What's Being Done?
In the labs, cells are suspended in a nutrient liquid solution and grown in sterile containers called tissue culture flasks. Cells then multiply and go through three, five or seven generations of growth.
FDA scientists are using a variety of cutting-edge methods to characterize cells and then determine if any of these characteristics can predict the behavior of the cells in biological assays or in animal models. The next step will be to determine if any characteristics they measure will predict the safety or effectiveness of stem-cell based products in patients.

Specifically, scientists will continue studying whether factors such as different methods of growing the cells, donor age or gender affects the cells’ quality and performance. This research will ultimately provide new tools to the community of academic and private industry scientists who are interested in evaluating and developing stem cells into new clinical treatments.

“The consortium has shown that widely accepted ways to identify and characterize MSCs do not reveal some important biological differences between batches of these cells,” Bauer says. So the consortium seeks to demonstrate ways to better characterize MSCs that will be used in clinical trials. That’s important because, if investigators can improve the tools used to characterize MSCs used for clinical trials, the data generated from their studies could also improve because their MSC products will be more predictable, he adds.

And the improved predictability of their products will, in turn, allow FDA scientists to more easily evaluate the safety and effectiveness of new stem cell technologies—a key part of the regulatory science that is the foundation of FDA decisions.

Agency scientists already have published six papers in scientific journals such as Tissue Engineering and Cytotherapy. “We’re hoping this project will inspire people to do more research in this area,” Bauer says.

Stem cells, like other medical products intended to treat, cure or prevent disease, require FDA approval before they can be marketed. “It is important for FDA to maintain a sound regulatory science research program to promote the development of safe and effective products in emerging areas that hold great promise,” Bauer says.

“My colleagues and I hope our scientific findings will be helpful in the field of regenerative medicine, including the ability to repair or even replace organs and tissues more safely and effectively than traditional means,” he adds. “Although there are many scientific hurdles to overcome before the use of stem cells reaches its full potential, I think this medicine will eventually have the capacity to do that.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Wednesday, April 23, 2014

CYRAMZA APPROVED BY FDA FOR TREATMENT OF STOMACH CANCER

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
For Immediate Release: April 21, 2014

Consumer Inquiries: 888-INFO-FDA

FDA approves Cyramza for stomach cancer

The U.S. Food and Drug Administration today approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.

Stomach cancer forms in the tissues lining the stomach and mostly affects older adults. According to the National Cancer Institute, an estimated 22,220 Americans will be diagnosed with stomach cancer and 10,990 will die from the disease, this year.

Cyramza is an angiogenesis inhibitor that blocks the blood supply to tumors. It is intended for patients whose cancer cannot be surgically removed (unresectable) or has spread (metastatic) after being treated with a fluoropyrimidine- or platinum-containing therapy.

“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Cyramza is new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.”

Cyramza’s safety and effectiveness were evaluated in a clinical trial of 355 participants with unresectable or metastatic stomach or gastroesophageal junction cancer. Two-thirds of trial participants received Cyramza while the remaining participants received a placebo. The trial was designed to measure the length of time participants lived before death (overall survival).

Results showed participants treated with Cyramza experienced a median overall survival of 5.2 months compared to 3.8 months in participants receiving placebo. Additionally, participants who took Cyramza experienced a delay in tumor growth (progression-free survival) compared to participants who were given placebo. Results from a second clinical trial that evaluated the efficacy of Cyramza plus paclitaxel (another cancer drug) versus paclitaxel alone also showed an improvement in overall survival.

Common side effects experienced by Cyramza-treated participants during clinical testing include diarrhea and high blood pressure.

The FDA reviewed Cyramza under its priority review program, which provides an expedited review for drugs that have the potential, at the time the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition. Cyramza was also granted orphan product designation because it is intended to treat a rare disease or condition.

Cyramza is marketed by Indianapolis-based Eli Lilly.

For more information:

FDA: Office of Hematology and Oncology Products

FDA: Approved Drugs: Questions and Answers

FDA: Drug Innovation

NCI: Stomach Cancer

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Tuesday, April 22, 2014

FDA SCIENTIST WORKING TO CREATE DNA BAR-CODES TO IDENTIFY FISH SPECIES

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

Have you sometimes wondered if that "wild caught" salmon actually came from an aqua farm? Or if the "U.S. catfish" in the display case might have been born and raised in Vietnam?

Is that "red snapper" actually red snapper and worth the premium price?

Scientists at the Food and Drug Administration (FDA) are able to answer those questions through a project that creates DNA barcodes to identify individual fish species. The massive project is part of an effort aimed at solving the problem of species substitution.

Species substitution can result in cheap fish being labeled as pricy ones, but mislabeling can also threaten public health. For example, in 2007, a prohibited and highly toxic variety of puffer fish, also known as fugu or blowfish, was smuggled into the U.S. in boxes labeled as "headless monkfish." This deception resulted in illnesses in multiple states.

A series of cutting-edge tests must be conducted to create the barcodes, which look much like the lines of different thicknesses on Universal Product Code (UPC) labels used to identify and scan manufactured products. However, unlike the barcodes you see on packages in the supermarket, the barcodes that identify different fish species will not be attached to the fish.

Instead, once a fish species is identified through DNA testing and other high-tech techniques in FDA labs, the newly created barcode unique to that species is entered into a database, which could be thought of as a library or catalogue of commercial fish species.

When encountering a fish or fish product (fillets, fish sticks, sushi, etc.) whose species is unknown, inspectors with the equipment and know-how can create a barcode for that fish and compare it against FDA's database to seek a known match.

The agency has trained more than 20 FDA analysts around the country to use that procedure in many of its regional field laboratories and are now performing the analysis on a regular basis.

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