FDA Denies Requests for Reconsideration

Stemming from the recent crackdown on unapproved cough and cold drugs, the U.S. Food and Drug Administration (FDA) recently denied two citizen petitions for reconsideration of the Agencys action. Submitted by the pharmaceutical companies ECR Pharmaceuticals (ECR) and Laser Pharmaceuticals, LLC (Laser), the requests sought review of the FDAs decision to rid the market of these products without permitting the companies the opportunities for hearing and asked the Agency to stay future enforcement action, allowing their products to remain on the market until the issues were resolved. In what ultimately resulted in a dismissal based on procedural grounds, the FDA reaffirmed both its hard-line stance against these over-the-counter (OTC) unapproved medicines as well as the narrow grounds on which the Agency will allow an administrative appeal of its actions.

As we previously reported, the FDA announced early this year that it was going to begin taking action against manufacturers of unapproved cough and cold products that were formerly part of its DESI program. Beginning in the 1980s, the several unapproved drugs were temporarily exempted from FDAs standard approval process through this program because of the drugs similarities to other approved prescription drugs and OTC drugs. Under this program, the FDA allowed these products to be marketed and sold until final DESI determinations were made. Until early this year, when FDA announced it was ending the exempt status of these drugs, many of these drugs remained on the market.

Seeking to prevent future enforcement action against them, ECR and Laser sought hearings from the FDA concerning the safety and effectiveness of the companies respective OTC drugs. Having denied the requests, the companies then each sought reconsideration of FDAs decision to abruptly end their exempt statuses under the DESI program.

Ultimately, the FDA denied both petitions on procedural grounds, citing to the Agencys regulations as limiting the scope of administrative reconsideration to certain specified matters. Referring to its regulations in its denials, the FDA noted that “[t]he Agencys regulation on reconsideration at 21 CFR 10.33 provides that a person may request reconsideration of FDA decisions on certain types of petitions formally submitted to the Agency.”

Provided in this regulation are the matters that may be subject to administrative reconsideration. Under 21 CFR 10.25, the types of actions amenable to administrative reconsideration are listed and include: new drug applications, color additive petitions, etc. Additionally, these actions include citizens petitions requesting that the FDA issue, amend, or revoke a regulation, as well as refraining from taking any other form of action. While the text of the regulation does not provide an exhaustive list of the types of action that may be the subject of administrative reconsideration, these recent denials have made it clear that the FDA is interpreting the availability of this form of review very narrowly.

For more information on FDA enforcement measures or compliance, please contact us at contact@fidjlaw.com.

USDA Proposes Mandatory Livestock Tracking System

On August 9, 2011, the U.S. Department of Agricultures (USDA) Animal and Plant Health Inspection Service (APHIS) issued a proposed rule to establish a mandatory livestock tracking system in order to improve the traceability of U.S. livestock. The proposed rule would require farmers and ranchers to affix unique identification numbers to animals transported interstate. The rule seeks to establish an effective, transparent animal disease traceability system without additional burden on farmers and ranchers. The tracking system would allow federal officials to quickly isolate diseased animals in the event of an outbreak.

In 2004, the USDA began developing a framework for animal disease traceability through the implementation of the National Animal Identification System (NAIS). NAIS is a voluntary registration system established to trace the source of an animal disease within 48 hours. However, in 2009, the USDA estimated that only 36 percent of farmers and ranchers participated in the NAIS. In order to improve traceability, APHIS launched a series of efforts to assess the acceptance of an animal disease traceability system which lead to the development of the proposed rule.   

The proposed rule requires that livestock moved interstate be officially identified and accompanied by an interstate certificate of veterinary inspection or other documentation, such as owner-shipper statements or brand certificates, unless exempt. Official forms of identification include tattoos, metal eartags, or brands with certain exceptions. The proposed rule also allows for States and tribes to develop alternative forms of identification. Livestock subject to the identification requirements include cattle, bison, sheep, goats, swine, horses, captive cervids, and poultry.

The USDA is confident that the new system will be able to trace the source of an animal disease within a few days of an outbreak. Advocates say the implementation of the new mandatory system would be a significant improvement compared to USDA bovine tuberculosis investigations averaging 150-days to trace the source of an outbreak.  

The USDA is currently seeking public comment on the proposed rule for a mandatory livestock tracking system. The deadline for submission is November 9, 2011. Fuerst Ittleman will continue to monitor the development of the USDA APHISs new proposed rule. For more information, please contact us at contact@fidjlaw.com.

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

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

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

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

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

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

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

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

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.