May 2011

Topic of the Month:  In May, the FDA promulgated two new regulations concerning the safety and security of foods in the United States. The rules are the first to be issued by the FDA under the new authorities granted the agency by the FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in January. Both rules will take effect July 3, 2011.

The first rule strengthens FDA’s ability to prevent potentially unsafe food from entering commerce and allows the FDA to administratively detain food the agency believes has been produced under insanitary or unsafe conditions.  Previously, the FDA’s ability to detain food products applied only when the agency had credible evidence that a food product presented was contaminated or mislabeled in a way that presented a threat of serious adverse health consequences or death to humans or animals.

The second rule requires anyone importing food into the United States to inform the FDA if any country has refused entry to the same product, including food for animals. The new requirement will provide the agency with more information about foods that are being imported, which improves the FDA’s ability to target foods that may pose a significant risk to public health.

I. Food Developments

Administrative detention of food authorized
Under an interim final rule, the FDA amended regulations to change the criteria used in ordering administrative detention of food for human or animal consumption. The FDA will be authorized to order administrative detention if there is reason to believe that an article of food is adulterated or misbranded, which according to the agency will further help it prevent potentially harmful food from reaching U.S. consumers. The prior regulation provided the FDA with the authority to order the detention of an article of food if during an inspection, examination, or investigation, an FDA officer or qualified employee found credible evidence or information indicating that the article of food presented a threat of serious adverse health consequences or death to humans or animals. The new criteria provides the FDA with the authority to detain articles of food that may be adulterated or misbranded for 20 calendar days with a possible 10 calendar day extension if needed to initiate legal action..  FDA Interim Final Rule, ¶40,427

Imported food notification required
An interim final rule (IFR) promulgated by the FDA will require a person submitting prior notice of imported food, including food for animals, to report the name of any country that refused the entry of the food into its borders. The new requirement will allow the FDA to make informed decisions in managing the potential risks of imported foods into the United States especially in the areas of safety and security risks to U.S. consumers.  The new reporting requirement will be administered through the FDA’s prior notice system for incoming shipments of imported food established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.   FDA Interim Final Rule, ¶40,428

II. Drugs and Biologics Developments

Clinical investigator financial disclosure guidance published
The FDA issued a draft guidance titled “Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators” to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators. With the draft document, the FDA notes: (1) the sponsor’s responsibility to collect the financial disclosure information prior to an investigator participating in a study and ensure that all required forms and attachments are submitted in marketing applications; (2) the definition of “due diligence” in obtaining financial disclosures from investigators; and (3) methods the agency will review financial disclosure information. FDA Notice, ¶42,111

Increase in pay-for-delay settlements reported
On May 3, 2011, the Federal Trade Commission (FTC) issued a staff report detailing the increasing number of pharmaceutical companies striking deals in fiscal year (FY) 2010 in which the manufacturers of branded drug products paid potential generic rivals to defer the introduction of lower-cost medicines, known as pay-for-delay settlements. The staff report summarizes data on patent settlements filed with the FTC and the Department of Justice during FY 2010. The FTC report found that the number of these deals increased by more than 60 percent, from 19 in FY 2009 to 31 in FY 2010.

Overall, the agreements brand-name companies paid generic challengers to settle their patent challenges and delay the introduction of lower-cost medicines in the latest fiscal year involved 22 different brand-name pharmaceutical products with combined annual U.S. sales of about $9.3 billion. The FTC noted that settlements that included a payment delayed generic entry by 17 months longer on average than those that did not include a payment..

The FTC has challenged a number of these patent settlement agreements in court, contending that they are anticompetitive and violate U.S. antitrust laws. The agency also has supported legislation in Congress that would prohibit settlements that increase the cost of prescription drugs.  There were also 113 final patent settlements of which 31 settlements contained a payment to a generic manufacturer and restricted the generic’s ability to market its product. Within the 31 payment settlements, 26 involved generics that were so-called “first filers, meaning that the generic manufacturer was the first to seek FDA approval to market a generic version of the  branded drug. Because of the drug product regulatory framework, other generic manufacturers can be blocked from entering the market when the first filers delay entering the market.  FTC News Release

III. Medical Devices Developments

Bacillus species diagnostic device proposed for Class II special controls
The FDA would classify in vitro diagnostic devices for Bacillus species (spp.) detection into Class II (special controls) as a limitation on the distribution of the device. After considering public comments on the proposed classification, the FDA will publish a final regulation classifying this device. Class II special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of the device, and according to the agency there is sufficient information to establish special controls to provide such assurance.

Currently most marketed diagnostic test kits have extremely high predictive values. Sensitivities of these devices (proportion of positive patients correctly identified by the test) have been tested to be over 99 percent and specificities (proportion of negative patients correctly identified by the test) approach 100 percent. Although the agency noted that increased level of public attention and concern towards potential inhalational anthrax exposures that resulted from previous incidents, a majority of device manufacturers were not interested in conducting necessary investigations to ensure the safety and effectiveness of test kits. In the absence of the proposed rule, there would continue to be ambiguity as to the specific testing criteria for the device to be cleared for marketing. In addition, FDA resources will be spent responding to these inquiries for potential products that are not destined to be marketed.

Additionally, a draft guidance titled “Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection” was published by the FDA as the special controls document to support the classification of in vitro  diagnostic devices into Class II devices. The draft special controls guidance document was developed to support the proposed classification of the device, which was a previously unclassified preamendments device.  FDA Proposal, ¶11,891