FDA Announces Public Meeting on Approval Pathways for Biosimilars

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The U.S. Food and Drug Administration (FDA) has announced that it will hold a two-day public hearing on November 2-3, 2010 for the purpose of gathering “input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).”

The Patient Protection and Affordable Care Act (Pub. L. 111-148), signed into law by President Obama in March of this year, contains the BPCI Act. The BPCI Act amends the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products. In order to take advantage of this abbreviated pathway, these biological products must be shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product.

Biosimilarity may be demonstrated through the use of scientific support (clinical trials, animal studies, etc.) with the appropriate number of trials and appropriate types of studies. The appropriate number and type required will be determined by the FDA. For a product to be considered biosimilar, data collected from the requisite study/studies must show that the biological product is “highly similar to the reference product, notwithstanding minor differences in clinically inactive components.” While it is unclear what level of clinical similarity is required to reach the finding of “highly similar”, The Agency intends to address this issue during the November hearing.

For more information on biologics or the BPCI Act, contact us at contact@fidjlaw.com.

More News on the Coming Wave of FDA Enforcement Actions

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Yesterday we reported the comments of Eric Blumberg, FDA Deputy Chief Counsel for Litigation, who said that the FDA will increase misdemeanor criminal prosecutions for pharmaceutical executives whose companies are promoting off-label uses of their products. At this same conference, sponsored by the Food and Drug Law Institute, additional guidance was provided for the pharma industry with respect to coming trends in FDA enforcement and how companies can achieve compliance now.

In addition to prosecuting off-label marketing of pharmaceutical products, Blumberg also warned that criminal investigations will increase and be focused on the distribution of unapproved new drugs as well as the failure to report unexpected adverse events caused by these products.

Eugene Thirolf, Director of the Office of Consumer Litigation at the Department of Justice (the FDAs government prosecutor), echoed Blumbergs comments stating that he foresees more criminal prosecutions arising from safety issues related to pharmaceutical products; e.g., distribution of defective products, adverse event reporting failures and fraudulent use or reporting of testing data.

This increased emphasis on criminal investigations and prosecutions by the FDA and the Justice Department are not just confined to consumer issues, however. Blumberg, Thirolf and several other speakers also discussed holding pharma companies accountable for regulatory issues arising from manufacturing. Company executives were admonished to adhere to current Good Manufacturing Practice (cGMP) regulations and standards, and cautioned not to ignore (or cover-up) safety issues discovered in the manufacturing and testing of pharmaceutical products. Thirolf stated that criminal prosecutions could arise from false documentation of manufacturing processes and procedures.

Much of the impetus for these new investigations and prosecutions will come from the FDAs Office of Criminal Investigations, which the agency has pledged to revamp and refocus.

The message from the FDA is clear “ not only for pharmaceutical companies, but for dietary supplement companies, medical device manufacturers, food producers, cosmetic companies and other FDA regulated industries as well:

Now is the time to proactively implement FDA compliance programs, to perform audits of your existing compliance programs, and to review your manufacturing processes, distribution networks, advertising, websites, and promotional activities to ensure compliance with FDA laws and regulations. Failure to do so now will result in even greater problems “ including criminal investigations and prosecutions “ later.

FDA Message to Pharma: Misdemeanor Criminal Charges can Result from Promoting Off-Label Drug Uses

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The FDA should target for misdemeanor criminal prosecution the executives of pharmaceutical companies which promote unauthorized uses of their medicines.

This is the latest message from Eric Blumberg, Deputy Chief for Litigation for the U.S. Food and Drug Administration. Speaking at the “Enforcement and Litigation Conference” for the Food and Drug Law Institute on October 13, 2010, Blumberg said, “Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion.”

Blumberg cited a recent case involving Pfizer in which the company agreed to pay a $2.3 billion fine for the off-label marketing of several products. Some industry analysts point to the Pfizer case as evidence that big pharma increasingly sees FDA fines and settlement agreements referencing “corporate integrity” as nothing more than a cost of doing business, and not changing industry practices. “Its clear were not getting the job done with large, monetary settlements,” Blumberg added.

This is not the first time Blumberg “ and the FDA “ has talked about getting tough with criminal prosecutions for drug law violations.

Not long after his appointment as the FDAs top litigator in 2005, Blumberg stated that senior executives should be held accountable for company actions under Federal Food, Drug and Cosmetic Act (FD&C Act). He warned that ignorance is not bliss, and also is not a defense in court. “The FD&C Act is a strict liability statute,” Blumberg said to a conference of pharmaceutical companies. “That means you may be found criminally responsible for a violation of the FD&C Act, even though you did not participate in the violation, you were not aware of the violation, or you did not act with criminal intent, or even negligence.”

Blumbergs words echo the so-called Park Doctrine, named after the Supreme Court decision in United States v. Park, 421 U.S. 658 (1975). This doctrine allows the government to seek criminal convictions against company officials for alleged violations of the FD&C Act.

In that case, the conviction of John Park, President of a national retail food chain, was upheld by the Supreme Court. The Court ruled that senior executives of companies manufacturing or selling FDA-regulated products have an affirmative duty to ensure the safety of those products. The Court further held that the U.S. Government can criminally prosecute corporate officers who are in a “responsible relationship” to an illegal activity by a company even if the person did not take part in, or even know of, the companys activities. The FD&C Act, according to the Court, imposes a positive duty on senior company officers to seek out and remedy violations when they occur as well as implement processes to prevent violations in the first place.

The Doctrine was used extensively by the FDA in the 1970s in strict liability cases usually involving “dirty warehouses” “ unsanitary facilities maintained by a company. But by the early 1980s, use of the Park Doctrine in criminal prosecutions had fallen off, due in part perhaps, to the meager penalties for misdemeanor convictions, which often were as low as $50.

Then in 2008, the U.S. Sentencing Commission adopted new guidelines that increased the likelihood that misdemeanor convictions under the Doctrine will result in prison time. These changes, along with higher penalties and the passage of new laws increasing the FDAs enforcement authorities and postures seem to have resurrected use of the Park Doctrine.

While Blumberg stated yesterday that his comments did not reflect FDA policy, they do reflect the thinking of the agencys senior management. In a March 2010 letter from FDA Administrator Margaret Hamburg to the Senate Finance Committee, Hamburg also stated that the FDA plans to increase misdemeanor prosecutions of pharma industry executives as it refocuses its Office of Criminal Investigations on stricter enforcement measures.

Blumberg added yesterday that pharmaceutical company officials shouldnt wait until they are criminally charged to begin bringing their marketing campaigns into compliance with FDA regulations. “If youre a corporate executive or are advising a corporate executive, now is the time to comply,” he said. “That conduct may already be under the criminal microscope.”

And quite a microscope it is. Under current law, misdemeanor cases carry sentences for company execs of up to a year in prison and/or a maximum fine of $100,000 per count. If the crime results in death, however, the maximum fine for an individual is $250,000. The FDA also can bar individuals from working in the industry.

FDA and CMS Consider Parallel Review of Medical Products

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The U.S. Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) recently announced in a Federal Register Notice that they are considering establishing a parallel review process for medical products, including pharmaceuticals, biologics, and medical devices. The goal of the parallel review process is to reduce the time between FDA marketing approval or clearance decisions and CMS national coverage decisions (“NCDs”). Currently, FDA will first conduct a premarket review that assesses the safety and effectiveness of the medical products. CMS conducts a second review to determine whether the medical product will be covered by Medicare.

The agencies envision that the manufacturer of a specific medical product will request that the agencies undertake the parallel review process and the agencies will then both provide their agreement to participate in the parallel review process. The FDA would make its approval or clearance determination first because CMS would not normally provide coverage to a medical product that was not approved or cleared by the FDA. Each agency will continue to use its own regulatory and evidentiary standards for decision-making. The medical product sponsor would be expected to meet the legal requirements for both the FDA and CMS.

The agencies are seeking comments from the public on what products would be appropriate for parallel review, what procedures should be developed, how a parallel review process should be implemented, and any other issues related to operation of the process. In addition, the agencies are announcing the intent to begin a pilot program for parallel review of medical devices. All electronic or written comments must be submitted by December 16, 2010.

For more information on how FDA and CMS review medical products and how the parallel review process may be beneficial to your product, please contact us at contact@fidjlaw.com.

Allergan Pleads Guilty To Misbranding Charge Agrees To Pay $600 Million In Fines And Penalties

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Allergan, Inc., the manufacturer of Botox ® Cosmetic, has agreed to plead guilty to one count of misbranding, a violation under the Food, Drug, and Cosmetic Act (“FDCA”). The company pled guilty to misbranding for its off-label promotion of Botox for unapproved uses.

Botox is an injectable neurotoxin commonly used in cosmetic procedures to smooth wrinkles. The FDA has also approved the use of Botox to treat certain muscle spasms and excessive underarm sweating. However, authorities allege that from 2000 to 2005 Allergan marketed Botox for use in treating headaches, pain, muscle stiffness, and cerebral palsy in juveniles, none of which were ever approved by the Food and Drug Administration (“FDA”). Under Federal law, although doctors can prescribe drugs for unapproved uses, pharmaceutical companies are prohibited from advertising or promoting unapproved uses for drugs currently on the market. Authorities also allege Allergan paid kickbacks to doctors who used Botox for off-label purposes and taught doctors how to miscode Botox claims when submitting these claims for Medicare and Medicaid billing.

Under the terms of the plea agreement, Allergan agreed to plead guilty to one count of misbranding and will pay $375 million in criminal penalties. The company also agreed to a five year compliance plan that will require it to disclose payments to doctors on its website and have senior executives and board members annually certify that the company is complying with federal regulation. The plea agreement also required the company to drop its lawsuit against the FDA which it filed in October 2009 that challenged an FDA rule that prohibits pharmaceutical companies from marketing drugs for off-label uses. Allergan also agreed to pay $225 million to resolve the civil claims against the company filed by five whistle-blowers in Georgia under the False Claims Act. The $600 million settlement is the fifth largest amount paid by a single defendant in a misbranding case.

In the wake of the companys guilty plea and $600 million penalty, a shareholder of Allergan has filed suit against the members of Allergans board of directors. The suit, filed in Delaware state court, alleges breaches of fiduciary duties and is seeking to shift settlement costs to the members of the Allergan board of directors in an effort to hold board members responsible for the $600 million in penalties the company now faces.

For more information on FDA regulations, labeling guidelines, and acceptable pharmaceutical marketing practices please contact us at contact@fidjlaw.com.

Forest Pharmaceuticals To Plead Guilty For Food, Drug, And Cosmetic Act Violations

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On September 15, 2010, the Food and Drug Administration (“FDA”) announced that Forest Pharmaceuticals (“Forest”) has agreed to plead guilty to two violations of the Food, Drug, and Cosmetic Act (“FDCA”). Forest has agreed to plead guilty to one count of distributing an unapproved drug in interstate commerce and one count of distributing a misbranded drug in interstate commerce. Additionally, Forest has agreed to plead guilty to one count of obstruction of justice. Charges stem from Forests marketing of two drugs, Levothroid and Celexa.

In 1997, the FDA announced that Levothroid, though already on the market, would be considered a new drug within the meaning of the FDCA. At that time, the FDA advised drug manufacturers that in order to continue to market Levothroid they would have seek new drug approval by the FDA. However, Forest failed to obtain drug approval, continued to market unapproved Levothroid, and disregarded an FDA warning letter ordering Forest to stop production and distribution. As a result of these actions, Forest was charged with distribution of an unapproved drug in violation of the FDCA.

U.S. authorities also charged Forest with distributing a misbranded drug based on its off-label marketing of Celexa to treat depression in children though the drug was only approved for use in adults. Prosecutors allege that Forest paid doctors to prescribe Celexa and failed to inform prescribing doctors of negative studies regarding the effects of Celexa on adolescents. Forest was also charged with obstruction of justice because of false statements made by employees during the FDA investigation.

As part of the plea agreement, Forest has agreed to plead guilty to all three counts and pay $164 million in criminal penalties. Additionally, Forest has agreed to resolve a civil complaint against it by paying $149 million in civil fines and entering into a Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services.

For more information on FDA regulation and labeling guidelines, please contact us at contact@fidjlaw.com.

FDA Cracks Down On Nutrition And Health Claims By Green Tea Makers

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The Food and Drug Administration has issued warning letters to two large producers of green tea drinks to discontinue unauthorized and unproven health and nutrient claims on their labels and websites. The warning letters were issued to the Dr. Pepper Snapple Group for its Canada Dry Sparking Green Tea Ginger Ale (“Canada Dry”) and to Unilever Inc. for its Lipton Green Tea 100% Naturally Decaffeinated product (“Lipton”). The warning letters are part of a larger campaign by the FDA to improve the accuracy and useful information of food labeling.

In its warning letter to Canada Dry, the FDA stated that the company’s sparkling green tea ginger ale made improper claims to be “enhanced” with antioxidants. Canada Dry’s label claims its green tea ginger ale is “enhanced with 200mg of antioxidants from green tea and vitamin C.” However, because Canada Dry is a carbonated drink, the FDA classifies it as a snack food. Current FDA policy does not consider it appropriate to fortify snack foods. As a result, Canada Dry cannot claim that its product is enhanced with antioxidants. Additionally, the FDA also warned Canada Dry that the ingredients claiming to contain antioxidants “are not nutrients with recognized antioxidant activity” under FDA regulations. As a result of these violations the FDA has found Canada Dry to be misbranded under the Food Drug and Cosmetic Act (“FDCA”).The full warning letter to Canada Dry can be read at: FDA Warning Letter To Canada Dry.

Unilever, the manufacturer of Lipton, was warned that its website for its Lipton product made misleading health claims and that Lipton’s antioxidant labeling did not follow FDA guidelines. In its warning letter, the FDA takes issue with Lipton’s website’s reference to four studies that showed a cholesterol-lowering effect of drinking green tea. The FDA found that the therapeutic claims are misleading because it suggests that Lipton is designed to treat or prevent disease. The FDA stated that these claims would result in Lipton being classified as a drug under the FDCA and subject Lipton to requirements for proving the safety and effectiveness of the cholesterol-lowering claims before the product could be legally marketed in the US. The FDA also stated that Lipton’s antioxidant labeling claims violate several federal guidelines. Due to these violations, the FDA has found Lipton to be misbranded under the FDCA.  A full copy of the FDA’s warning to Lipton can be read at: FDA Warning Letter To Lipton.

As the nutrient-enriched beverage market continues to grow into a multibillion dollar business, the FDA will continue its efforts to crack down on companies that overstate the benefits of their products. For more information on FDA regulation and labeling guidelines, please contact us at contact@fidjlaw.com.

FDA Closer To Approving Genetically Modified Salmon

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The Food and Drug Administration (“FDA”) has moved one step closer to approving the first genetically modified animal food for human consumption, genetically modified Atlantic salmon. The impending decision has caught the eye of investors, biotechnology companies, consumer groups and environmental organizations.

On September 3, 2010, a panel of scientists advised the FDA that AquaAdvantage salmon, a genetically modified version of Atlantic salmon, was safe to eat. The panel also found that genetically modified salmon have no biologically relevant differences from ordinary farm raised Atlantic salmon and both contain the same amount of nutrients.

The key difference between the genetically modified salmon and the ordinary salmon is its rate of growth. Normally, Atlantic salmon take close to 3 years to fully develop because its growth rate slows during cold weather. However, genetically modified Atlantic salmon have been modified by adding growth hormone genes from Chinook salmon and ocean pout, allowing these fish to grow to full size in only 18 months. The quicker growth rates allow farmers to increase production and yields.

The FDA is evaluating the genetically modified salmon as it does new veterinary drugs. As a result, much of the research and data gathered to determine the safety of these fish has been kept confidential. This has drawn criticism from consumer groups and independent labs concerned that an overworked and understaffed FDA may be missing something in its evaluation. Consumer groups are also concerned the genetically modified salmon could escape breeding tanks and breed with wild salmon. The FDA believes that genetically modified salmon will not pose a threat to the environment because 99% of all genetically modified salmon will be sterile and, unlike traditional farmed raised salmon which are raised in ocean based tanks, genetically modified salmon will be raised in inland tanks, minimizing the chances of escape.

An approval of genetically modified salmon for human consumption could open the door for other genetically modified animals to receive approval for human consumption. Currently, scientists are seeking FDA approval for a genetically modified hog, and are developing genetically modified cows that are resistant to mad cow disease.

The FDA is scheduled to hold public hearings on genetically modified salmon from September 19-21, 2010. The hearings will include discussions on the technology used to produce genetically modified animals and FDAs regulatory procedures for evaluating these animals, a discussion on the animal health, food safety, and environmental concerns associated with genetically modified salmon, and a discussion on potential labeling issues should the FDA approve genetically modified salmon for human consumption. More information regarding the upcoming hearings can be found on FDAs website at FDA Announces Public Meeting on Genetically Engineered Atlantic Salmon.

For more information regarding current FDA authority, procedure, or regulations please contact us at contact@fidjlaw.com.

FDA Begins Crackdown On E-Cigarette Industry Announces Intent To Regulate E-Cigarettes

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On September 9, 2010, the Food and Drug Administration (“FDA”) announced its intent to regulate electronic cigarettes and issued warning letters to five e-cigarette manufacturers for violations of the Food, Drug, and Cosmetic Act (“FDCA”). Warning letters were issued for various violations of the FDCA including violations of good manufacturing practices, making unsubstantiated drug claims, and using the devices as delivery mechanisms for active pharmaceutical ingredients. A copy of the FDAs press release can be read here: FDA Acts Against E-Cigarette Distributors.

E-cigarettes are battery-powered devices that allow users to inhale vaporized liquid nicotine instead of tobacco smoke. As these devices have become more popular, the FDA has become increasingly concerned with the safety and effectiveness of these devices as smoking cessation aids. In July, the FDA issued a press release expressing its concerns with the e-cigarette stating that because e-cigarettes have not been submitted to the FDA for evaluation or approval, the levels of nicotine and other chemicals that the products deliver to its users are unknown. The press release regarding safety concerns with the e-cigarettes can be read at FDA Warns of Health Risks Posed by E-Cigarettes.

In a letter to the Electronic Cigarette Association on September 8, 2010, the FDA advised the e-cigarette industry of its intent to regulate e-cigarettes. The FDA has determined that e-cigarettes “meet the definitions of both a drug and a device under the [FDCA] and the definition of a combination product in 21 C.F.R. Part 3, with a drug primary mode of action.” A full copy of the FDAs letter to the Electronic Cigarette Association can be read at FDAs Letter to the E-Cigarette Association.

As a result of this new classification by the FDA, e-cigarette manufacturers will have to comply with the FDCA and numerous regulations regarding the marketing and approval of drugs. Under the FDCA, a company must demonstrate that a drug is safe and effective for its intended use before that product will gain FDA approval. This will require e-cigarette manufacturers to provide proof that e-cigarettes safely and effectively reduce its users dependence on nicotine. Additionally, manufacturers must demonstrate that its manufacturing practices preserve the strength, quality, and purity of the drug. The FDCA also prohibits a company from claiming that a drug can treat or mitigate a disease, including nicotine addiction, unless the drugs safety and effectiveness has been proven.

For more information regarding current FDA authority, procedure, or regulations please contact us at contact@fidjlaw.com.

FDA Busy Crafting Calorie Court Regulations

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The FDA has begun the process of establishing regulations to implement recent federal law that mandates calorie information be posted at many chain restaurants and vending machines throughout the United States. The mandate was signed into law on March 23, 2010, as part of the Patient Protection and Affordable Care Act, (“PPACA”) and requires that all restaurants with 20 or more locations post calorie counts of their products on menus, menu boards, and drive-through menus. Other nutritional information, including amounts of sodium, saturated fats and cholesterol must be made available to consumers in written form upon request. Additionally, all chain restaurants must include on their menus the Secretary of the Department of Health and Human Services statement on suggested daily calorie intake.

The PPACA requires chain restaurants to label the calorie content for standard menu items and self-service foods, such as buffets and salad bars. However, foods that are daily specials, limited-time offerings, or seasonal items are exempt from the calorie count legislation. Also, vending machines must display calorie disclosures for each item offered for sale unless the Nutritional Facts panel for a food is available for the customer to view prior to purchasing.

The federal calorie count legislation is intended to create a uniform national policy on nutritional information available on chain restaurant menus. PPACA is similar in design and purpose to several state laws and local ordinances requiring calorie count displays at chain restaurants. New York City currently has such a calorie count display law in effect. The National Restaurant Association supported the implementation of a federal guideline as an alternative to numerous labeling schemes that could vary from state to state.

The FDA has until March 2011, one year from the passage of the PPACA, to develop and implement regulations to enforce the calorie count mandate. Once implemented, the FDA will be in charge of enforcement and penalties for violations. On July 7, 2010, the FDA began receiving public comments on how to implement section 4205 of the PPACA. The comment period runs for 60 days and will close on September 5, 2010.

For more information regarding current FDA authority, procedure, or regulations please contact us at contact@fidjlaw.com.