Food Drug & Devices – February 2010

I. Agency Developments

Food safety and medical regulations highlight 2011 budget request

The FDA requested $4.03 billion to promote and protect public health as part of the fiscal year (FY) 2011 budget – a 23 percent increase over the agency’s current $3.28 billion budget. According to the FDA, the budget request reflects the agency’s resolve to transform food safety practices, improve medical product safety, protect patients, and modernize FDA regulatory science to advance public health. A portion of the funding in the FY 2011 request also would support new regulatory authority over cigarettes and other tobacco products under the Family Smoking Prevention and Tobacco Control Act (Public Law 111-31, ¶2006).

The FDA identified major initiatives that the funds would be allocated towards, including:

l an additional $318.3 million requested for food safety measures to set standards, expand laboratory capacity, pilot track and trace technology, strengthen import safety, improve data collection and risk analysis, and begin to establish an integrated national food safety system with strengthened inspection and response capacity;

l $215 million funded by an increase in tobacco user fees to promote public understanding of the harmful constituents of tobacco products, develop the foundation of science for regulating tobacco, and regulate tobacco to reduce the toll of tobacco-related disease, disability and mortality; and

l an additional $100.8 million to protect patients through prioritizing the safety of drugs, devices, and vaccines, as well as the national blood supply.

The FY 2011 request, which covers the period of October 1, 2010, through September 30, 2011, includes increases of $146 million in budget authority and $601 million in industry user fees.  FDA News Release



Data falsification reporting requirement proposed

Under an FDA proposed rule, sponsors would be required to report to the FDA within 45 days information regarding individuals engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. The proposed requirement for a sponsor to report information regarding falsification of data would be ongoing and cover the periods before and after study completion, including after the review approval, or authorization of the affected product or labeling. Sponsors would be defined to additionally include, beyond as currently defined in the regulations: (1) petitioners submitting food additive, color additive, nutrient content claim, and health claim petitions; and (2) manufacturers or distributors submitting new dietary ingredient notifications. Sponsors would not include a federal agency that sponsors research or investigations through funding or contracts or an entity identified as a sponsor under other federal programs.

According to the FDA, ambiguity in the current reporting scheme has caused confusion among sponsors and the proposed rule would help ensure the validity of data that the agency receives. Although the agency’s inspections sometimes uncover falsification of data, sponsors of studies are responsible for ensuring the integrity of study data and are in a better position to discover possible falsification of data through their monitoring, auditing, and reviewing of data. The FDA recognized that in the process of reviewing and monitoring studies, some sponsors have discovered falsification of data and have been reluctant, or uncertain as to whether it was necessary, to report the information to agency.

Specifically, the proposed rule would amend regulations that govern the conduct of FDA-regulated research and the submission of information in support of applications and petitions for FDA product approvals for: (1) good laboratory practice for nonclinical laboratory studies; (2) color additive petitions; (3) petitions for nutrient content claims and petitions for health claims; (4) information in a premarket notification for a food contact substance; (5) food additive petitions; (6) dietary supplements; (7) investigational new drug applications; (8) new animal drugs for investigational use; (9) food additive petitions; and (10) investigational device exemptions. The FDA would use the information collected from sponsors to identify patterns, potential signals, or other indications of misconduct, to conduct further investigations. The investigations, in turn, would form the basis of administrative or enforcement actions, such as excluding clinical trials from consideration by the FDA, placing a clinical trial on hold, or initiating disqualification of investigators or criminal proceedings. FDA Proposal, ¶46,149.

II. Drug and Biologics Developments



Proprietary names usage for drug products, guidance

Recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary names for drugs, including biological products, and other factors that, in association with the name, can contribute to medication errors are provided in a guidance published by the agency. Titled “Contents of a Complete Submission for the Evaluation of Proprietary Names,” the guidance applies to prescription drug products that are the subject of an investigational new drug application (IND), new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or any nonprescription drug products that are the subject of an IND, NDA, or ANDA.

The information will be used in the assessment of promotional aspects of proposed proprietary names. The guidance revises a November 2008 draft guidance (¶41,862) to include: (1) clarifying that the purpose of the guidance is to provide a complete listing of the information the FDA needs to evaluate a proposed proprietary name; (2) adding the respective Prescription Drug User Fee Act review performance time frames for complete submissions of a proposed proprietary name submitted during the IND phase or with an NDA, BLA, or supplement; and (3) referencing the concept paper for a complete discussion of the tools and methods used for FDA’s safety evaluation that are mentioned in the proprietary names submission guidance.  FDA Notice, ¶41,996.

Drug abuse potential assessment requested

A draft guidance for sponsors developing drugs and medical products was published by the FDA to help assess abuse potential as part of the general evaluation of the safety and efficacy of the drug or drugs. Titled “Assessment of Abuse Potential of Drugs,” the draft guidance defines “abuse potential,” discusses how to submit an abuse potential assessment including a proposal for scheduling, and describes what constitutes an adequate abuse potential assessment. Currently, if a drug has abuse potential the Secretary of Health and Human Services is required to make a recommendation for scheduling to the Drug Enforcement Administration, and the FDA performs the scientific evaluation of the abuse potential. Drugs with abuse potential generally include drugs that affect the central nervous system, drugs that are similar to other drugs with known abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria or mood change. These drugs must be submitted with an assessment of the studies related to the potential abuse and include a proposal for scheduling.

An assessment should include all primary data related to the abuse potential characterization of the drug, organized under the subheadings: (1) chemistry; (2) preclinical pharmacology; (3) animal behavioral and dependence pharmacology; (4) pharmacokinetics and pharmacodynamics; (5) human abuse potential laboratory studies; (6) clinical trial data relative to abuse and dependence potential; (7) integrated summaries of safety and efficacy; and (8) foreign experience with drug. The FDA also suggests that drug sponsors consider studying and incorporating abuse deterrent formulations into their products, including formulations with physical barriers to tampering, combinations of an agonist with an antagonist, components that cause adverse events, and alternative methods of administration. Submit written or electronic comments by March 29, 2010.  FDA Notice, ¶41,992.


III. Devices Developments


Lack of authority to regulate electronic cigarettes

The FDA does not have the authority to regulate electronic cigarettes as a drug-device combination, because the intended use of the product was akin to traditional cigarettes. Two electronic cigarette manufacturers sought a preliminary injunction against the FDA, enjoining the FDA from regulating electronic cigarettes as a drug-device, after the FDA had detained inbound shipments to the U.S. as unapproved drug-device combinations under the FDC Act. According to the U.S. District Court for the District of Columbia, the manufacturers intended to sell their products for customary recreational use, thus, the products were properly excluded from the meaning of drug or device under the FDC Act. The electronic cigarettes were advertised as an alternative to traditional tobacco products and functioned by vaporizing a liquid nicotine mixture without fire, flame, tar, or carbon monoxide. The district court rejected the FDA’s reasoning that based on the labeling and promotional materials claiming to “prevent or alleviate nicotine withdrawal symptoms” the electronic cigarettes fell within the FDC Act’s definition of a drug-device combination and could be regulated, because the product was intended for use in the mitigation of disease. The inability to import the electronic cigarettes into the U.S. for distribution would deprive the manufacturers of needed revenue and threaten their continued viability. The motion for preliminary injunction was granted.  Smoking Everywhere, Inc. v. FDA, ¶39,120.