Johnson & Johnson Seeks Settlement in for Allegations of Off-Label Promotion of Risperdal

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In 2004, the U.S. Department of Justice (DOJ) Office of the Inspector General (OIG) began investigating Janssen Pharmaceutica Inc. (Janssen), a subsidiary of Johnson & Johnson (J&J), concerning the marketing practices for Risperdal, an antipsychotic prescription drug. Janssen allegedly promoted Risperdal for unapproved off-label uses, a misdemeanor criminal offense. Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act) manufacturers are prohibited from directly marketing a drug for a use other than the U.S. Food and Drug Administration (FDA) approved indication. 21 U.S.C. §§301-97. The FDA approved Risperdal for the treatment of schizophrenia in adults and adolescents. Allegations suggest that Janssen also promoted Risperdal for the treatment of dementia and anxiety disorders. See our previous report here for more information regarding misdemeanor criminal charges resulting from off-label promotion.

On August, 9, 2011, in a quarterly report filed with the Securities and Exchange Commission (SEC), J&J announced efforts to resolve the criminal penalties related to Risperdal marketing. J&J stated that an agreement had been reached with the DOJ regarding the key issues; however, the settlement has yet to be finalized. J&J adjusted its financial statements for the second quarter of 2011 to reflect the financial component of the proposed criminal settlement. 

In addition, J&J announced the settlement of a tolling agreement with approximately 40 states. The tolling agreement allows for the delay of the statute of limitations in order to provide J&J an opportunity negotiate civil claims with states before a state is forced to file a complaint to preserve their rights. J&J states litigation is likely if negotiated resolutions cannot be reached in regards to the civil litigation relating to the allegations of off-label promotion of Risperdal. Pursuant to the False Claims Act, companies who knowingly represent a false approval are subject to civil penalties. 31 U.S.C. § 3729. 

J&J claims that the resolution of the criminal and civil matters is not expected to have a material adverse effect on the Companys financial position, although the resolution in any reporting period could have a material impact on the Companys results of operations and cash flows for that period.

For more information regarding the drug approval process or for any questions regarding how your company can maintain regulatory compliance, please contact us at contact@fidjlaw.com.

FDA Giving the Opportunity to Comment on Possible Changes to the 510(k) Process

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On August 12, 2011, the U.S. Food and Drug Administration (FDA) announced its plans to hold a public meeting, where it will elicit comments from the public concerning the proposed changes to its 510(k) process. The meeting, which will be held next month, will focus primarily on the recommendations proposed in the recent report by the Institute of Medicine (IOM).

Currently, the 510(k) process is the means by which most medical devices are cleared by the FDA in order to be brought to market. While this process has remained relatively unchanged over the last three decades, there has been much attention over the past year of reforming it. As we previously reported, the plans to overhaul the system have been in the works since 2009. However, efforts to revamp the process have gained momentum only recently.

As we recently reported, IOM released its proposed recommendations on updating the 510(k) system. Found here, the report contains a number of changes that IOM suggests could help FDA ensure that medical devices are safer for the public. Because the IOM report suggests significant changes to the 510(k) process, including a total abandonment of the way the process currently operates, FDA is seeking public comment concerning these recommendations.

Fuerst Ittleman will continue to monitor the developments and changes to 510(k) premarket notification process. For more information, please contact us at contact@fidjlaw.com.

FDA Announces Public Workshop for Medical Apps

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On August 12, 2011, the U.S. Food and Drug Administration (FDA) announced its plans to hold a public workshop concerning its newly proposed regulation of mobile medical applications (“apps”). The meeting, which is scheduled for September 12, will focus on the emerging phenomenon of medical apps, defined as those applications used to diagnose or treat conditions.

As we previously reported, the FDA has recently been focusing in on medical apps inasmuch as they are transforming mobile devices into medical devices that are regulated by the Agency. Having issued its draft guidance last month, found here, the FDA is holding this workshop in an effort to gain further feedback from the public. The FDAs proposed oversight of these apps will be through the application of the same regulatory scheme that applies to traditional medical devices, and the workshop will provide the public with a forum to present the FDA with its concerns before the Agency finalizes its position on this new area of medical device regulation.

Fuerst Ittleman will continue to monitor the progress of the FDAs regulation of mobile medical apps. For more information, please contact us at contact@fidjlaw.com.

More Than Half-Dozen Strains of E. Coli are Deadly, One is Illegal

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A growing number of lawmakers, food-safety and consumer advocates are demanding that all lethal strains of Escherichia coli (E. coli) be declared adulterants when present in meat. There are seven known lethal strains of Shiga toxin-producing E. coli. Shiga toxin enters cells and stops the cells from producing proteins needed to function causing the cell to die. Symptoms include abdominal pain, bloody diarrhea, kidney failure and death.

Currently, E. coli O157:H7 (O157) is the only strain of Shiga toxin-producing E. coli to be singled out by the U.S. Department of Agriculture (USDA) as an adulterant when present in meat. Pursuant to the Federal Meat Inspection Act (FMIA), any raw ground meat that tests positive for O157 is declared adulterated and cannot be sold for human consumption. This regulation came in response to the 1993 Jack in the Box E. coli outbreak that sickened over 700 people in the U.S.

However, there are six other non-O157 Shiga toxin-producing strains of E. coli, known as the Big 6, which are not declared adulterants when present in meat. As a result, meat contaminated with the Big 6 can be sold for human consumption. The Big 6 usually require an illness to trigger a recall because the strains are often not tested for. The USDA decided to single out E. coli O157:H7 because it was especially virulent and caused illness when present even in very small amounts of cooked ground meat.

Following the recent E. Coli outbreak in Europe, U.S. Senator Kristen Gillibrand introduced the meat safety bill (S.1157) on June 8, 2011 that would require ground beef manufacturers to test meat for the Big 6 and other high-risk pathogens before and after the meat is ground. The meat safety bill calls for habitual violators to be listed on a public website. The bill is currently in the Senate Committee on Agriculture, Nutrition, and Forestry.

Critics of the meat safety bill argue that bacteria are constantly evolving and therefore requiring additional testing would not solve E. coli food safety issues. For example, the European E. coli variant that sickened more than 4,075 in Europe and killed 50 people was not known before this spring and is not part of the Big 6. Critics also note that contamination can be cooked out of fresh meat and additional testing would increase the price of ground beef for consumers.

Fuerst Ittleman will continue to monitor the progress of the meat safety bill and requirements for E. coli testing. For more information, please contact us at contact@fidjlaw.com

FDA Requests Public Comment on Notification of a Health Claim or Nutrient Content Claim

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Companies seeking to use health claims or nutrient content claims on food labeling must submit notification to the FDA prior to marketing. Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), such claims must be based on current, published, authoritative statements from certain federal scientific bodies. On August 3, 2011, the U.S. Food and Drug Administration (FDA) announced in the Federal Register that the Agency is seeking public comment concerning the collection of information associated with the submission of notifications of health claims or nutrient content claims.

In 1998, the FDA released guidance regarding the submission of health claims and nutrient content claims. At the time, the Agency stated that the notification must contain the exact wording of the claim, description of the basis relied upon, a copy of the statement referred to, a balanced representation of literature in a bibliography, and information on analytical methodology. The Agency estimates that review of the information collection will take 250-450 hours per notification depending upon the nature of the claim. Currently, the notification must be submitted to the FDA via regular mail.

The FDA invites public comment until October 3, 2011, regarding:

  • Whether the proposed collection of information is necessary for the proper performance of FDAs functions, including whether the information will have practical utility
  • The accuracy of FDAs estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used
  • Ways to enhance the quality, utility, and clarity of the information to be collected
  • Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques

Fuerst Ittleman will continue to monitor the FDA for changes to submission requirements for notifications of health claims or nutrient content claims. For more information regarding submission of notifications, contact us at contact@fidjlaw.com.

FDA Announces Updates to Premarket Review Standards

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On August 2, 2011, the U.S. Food and Drug Administration (FDA) published a notice for comment in the Federal Register regarding updated, withdrawn and modified standards for reviewing premarket applications for medical devices. The notice, entitled Modifications to the List of Recognized Standards, Recognition List Number: 027, is intended to “assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.”

This notice describes 1) the withdrawal of standards and their replacement by others; 2) the correction of errors made by the FDA in listing previously recognized standards; and 3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of these standards. The FDA will incorporate these modifications into the list of FDA Recognized Consensus Standards.

Fuerst Ittleman is well-equipped to assist members of FDA-regulated industry navigate the laws and regulations applicable to medical device applications in the United States. For more information about the current regulatory framework surrounding medical devices, please contact us at contact@fidjlaw.com.

FDA Seeks Comment on Food Safety Fees for Facility Reinspections

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On August 1, 2011, the U.S. Food and Drug Administration (FDA) posted a notice for public comment regarding food safety fees associated with facility reinspections. The passage of the Food Safety Modernization Act (FSMA) earlier this year granted the FDA authority to impose and collect fees from food producers when the Agency has to reinspect the facility for compliance with FDA regulations. The Federal Register notice seeks to “obtain information that will be used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small business.” The FDA will accept comments until October 17, 2011.

The FSMA was signed into law to enable the FDA to better protect public health by helping to ensure the safety and security of the food supply. The law provides the FDA with enforcement power intended to boost the rate of compliance with prevention- and risk-based food safety standards. The new section (32 U.S.C. 379j-31) of the Food, Drug, and Cosmetics Act (FDCA), “mandates that FDA assess and collect fees for costs associated with certain domestic and foreign facility reinspections, failure to comply with a recall orderand certain importer reinspections.”

In this Federal Register notice, the FDA is particularly interested in understanding how these costs may impact small business. In order to prepare for and develop guidelines in consideration of the burden of fee amounts on small businesses, the FDA will accept comments on the following questions:

  • Is a fee reduction or other consideration for small business appropriate?
  • How should small business be defined or recognized for the purpose of the proposed guidelines?
  • If FDA considers reduced fee amounts in the proposed set of guidelines, what factors should FDA consider in establishing the amount by which fees could be reduced?

The fees associated with FDA reinspections will be based on an estimation of 100 percent of the costs of the FDAs expenses, such as the inspectors time at the facility, travel expenses, related administrative tasks, and laboratory analysis. The FDA plans to accept public comment on the cost of fees after the fees are established and published in the Federal Register later this year.

Fuerst Ittleman will continue to monitor the developments in the FDAs regulation of food facilities. For more information, please contact us at contact@fidjlaw.com.

FDA to Launch Online Pet Food Tracking System

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Earlier this week, the U.S. Food and Drug Administration (FDA) announced the launch of Pet Event Tracking Network (PETNet), “a secure, web-based information exchange system that will allow FDA and Federal and State Agencies to share initial information about pet-food related incidents, such as illness associated with the consumption of pet food or pet food products.” The new system is intended to improve communication about the safety of pet food products across and within various levels of federal and state government.

This new online system was developed in response to the 2007 melamine pet food recall. (Robert Becerra of Fuerst Ittleman successfully represented the importer of the tainted pet food in the criminal prosecution filed by the U.S. Attorneys Office in Kansas City, Missouri.) At the time, the FDA struggled to effectively communicate information between the Agency and States about the dangers and contamination of certain pet food products. The following year, the FDA created the Partnership for Food Protection, a coalition to “bring federal, state, local, territorial and tribal representatives with expertise in food, feed, epidemiology, laboratory, animal health, environment and public health together to develop an Integrated Food Safety System.”

Together, the FDA and Partnership for Food Protection, launched PETNet. PETNet will function as a voluntary information exchange, surveillance, and alert system. It was designed to make real-time updates about emerging pet food related illnesses available to and accessible by members, government officials responsible for the regulation of pet food products. Members of PETNet can post “events” into the system identifying suspicions or trends in animal food products in their area. The web-based system can quickly and easily transmit information to other regulatory agencies and channels that would benefit from this information. PETNet will enable members able to track individual “events” to determine whether regulatory action needs to be taken in their jurisdiction. PETNet is currently comprised of over 200 representatives from four federal agencies, all 50 states, the District of Columbia and Puerto Rico.

Fuerst Ittleman will continue to track changes in the reporting and regulation of pet food products. For more information, please contact us at contact@fidjlaw.com.

FDA Responds to Requests to Finalize Rule for Gluten-Free Labeling

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On July 21, 2011, United States Senators Ron Wyden (D-OR) and Patrick Leahy (D-VT) urged U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg to take prompt action and finalize the proposed rule for gluten-free labeling. As we previously reported, the FDA has not defined “gluten-free” in over four years following the release of the proposed definition.

Pursuant to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCP), the FDA was tasked with proposing rules for gluten labeling within two years of enactment and finalizing the rules within four. The FDA issued a proposed rule in January of 2007, but has yet to promulgate a final rule. Senators Wyden and Leahy are concerned that the lack of federal standards has caused confusion for consumers. Accurately labeling gluten-free products would help those who suffer from celiac disease, a chronic inflammatory disorder of the small intestine which is triggered by certain proteins known as gluten.

Today, the FDA responded and reopened the public comment period on the proposed rule for “gluten-free” labeling for 60 days beginning August 3, 2011. The FDAs goal is to eliminate uncertainty about food labeling and assure consumers that foods labeled “gluten-free” must meet a clear standard established and enforced by the Agency. The FDA stated that the final rule will also apply to dietary supplements, whereas the proposed rule only applied to conventional food products.
In the proposed rule, a food labeled “gluten-free” does not contain any of the following:

  • Any type of wheat, rye, barley, or crossbreeds of these grains
  • An ingredient derived from these grains and that has not been processed to remove gluten
  • An ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten
  • 20 ppm or more gluten

Until the issuance of the final rule, Quality Assurance International (QAI) and the healthcare nonprofit National Foundation for Celiac Awareness (NFCA) created a “Certified Gluten-Free” label to assure customers about accurate gluten-free labeling. The label certifies that the food contains no more than 10 ppm of gluten.

This is not the first time that specific label terms have been left vague or undefined. For example, before the U.S. Department of Agriculture (USDA) finally took action to define the term “organic,” many consumers relied on third party certifications to ensure that food labels were accurate. USDA officials finally drafted a set definition for the term “organic” after seven years in 1997. See our previous report here for more information regarding this issue.
Fuerst Ittleman will continue to monitor the FDA for changes to gluten-free labeling requirements. For more information regarding the labeling of food products, contact us at contact@fidjlaw.com.

New Head of Global Compliance Seeks Increase of FDA Authority over Drug Imports and Recalls

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Last month, the U.S. Food and Drug Administration (FDA) appointed a new deputy commissioner for global regulatory operations and policy, Deborah Autor. Autor, the former director of the Center for Drug Evaluation and Research (CDER) Office of Compliance, is urging Congress to increase the FDAs authority over imported drugs and the power to mandate recalls of unsafe drug products.

The FDA has recently announced the new “Pathway to Global Product Safety and Quality” in response to mounting problems related to the importation of food and medical devices; however, it does not cover the importation of drugs. See our previous report for more information on the FDAs new global strategy. Autor is seeking more effective regulation of imported drugs to create drug security in a global pharmaceutical economy.

In an effort to ensure that drugs and clinical trials from abroad adhere to standards comparable to those in the U.S., Autor proposed that the FDA have the power to stop imported drugs at the border if the manufacturer has refused FDA inspections. The FDA states 80 percent of the active ingredients in U.S. drugs are manufactured overseas. Additionally, it is estimated that drug imports will triple by 2015, while it is likely that FDA budget will not. The FDA also estimated that it would take nine years for the agency to inspect every high priority pharmaceutical facility just once. Autor claims that having the authority to stop potentially unsafe drugs at the border will prevent risks associated with uninspected products. 

Autor has proposed FDA mandatory drug recall authority since the contaminated blood thinner, heparin, imported from China killed 81 people in 2008.  Pursuant to the Food Safety Modernization Act (FSMA), the FDA has the authority to order mandatory recalls of food but not drugs. Advocates say that the Senate Committee on Health, Education, Labor and Pensions is likely to give the FDA stronger authority over drugs as part of a broader bill to renew FDA industry fees, which will expire next year.

Fuerst Ittleman will continue to monitor the FDAs progress regulating the importation of drugs. For more information, please contact us at contact@fidjlaw.com.