Food, Drug & Devices Update – October 2010

Subscribers to the Food, Drugs, and Cosmetics and Medical Devices Reporter will now have access to the full text of the Public Health Service Act (PHSA) on IntelliConnect, instead of select excerpts.  Access to this title is especially important after enactment of health care reform in 2010, since the introduction of biosimilar pathway, drug labeling, and nutrition information were introduced in the reform law.
Topic of the Month: Investigational new drug applications were addressed by the FDA this past month. Regulations governing the safety reporting requirements were amended in consideration of bioavailability and bioequivalence studies.

I. Agency Developments

Enforcement action plan for tobacco promotion restrictions

A description of the FDA’s plan to enforce the restrictions on promotion and advertising of menthol and other cigarettes to youth and other requirements relating to tobacco product promotion and advertising established by the Family Smoking Prevention and Tobacco Control Act (Public Law No. 111-31, ¶ 2006) was published by the agency. Titled “Enforcement Action Plan for Promotion and Advertising Restrictions,” the plan outlines a multipronged approach including surveillance, inspections, enforcement actions, and education to enforce and facilitate compliance with these new restrictions and requirements. The action plan also includes provisions designed to ensure enforcement of the restrictions on promotion and advertising of menthol and other cigarettes to youth in minority communities. FDA Notice, ¶43,943

Comments opened on strategic priorities for FY 2011-2015

The FDA is seeking public comment on its draft Strategic Priorities for fiscal years (FY) 2011–2015. The FDA has identified these strategic priorities and goals that will guide its efforts to achieve its public health mission and is seeking public comment to help further refine these priorities and goals. FDA Notice, ¶43,944

II. Drug and Biologics Developments

IND safety reporting requirements amended

Regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND) were amended by the FDA in a final rule to codify the agency’s expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The agency clarified definitions, provided examples of the types of evidence that suggest a causal relationship for purposes of reporting a suspected adverse reaction to the IND and participating investigators, and revised the requirements for expedited reporting of serious and unexpected suspected adverse reactions to the IND.

Sponsors will be permitted to arrange alternative formats or frequencies for reporting.
Additionally, study endpoints must not be submitted as IND safety reports except in unusual cases. According to the FDA, the amendments to the regulations will not only have an impact on which reports are sent to the agency and participating investigators, but also affect the reports that are sent by investigators to Institutional Review Boards (IRBs). These revisions and clarifications will minimize reports that do not contribute to FDA’s understanding of the developing safety profile of the drug and decrease the number of uninterpretable reports in the system. The final rule is effective March 28, 2011.
Additionally, a draft guidance titled “Safety Reporting Requirements for INDs and BA/BE Studies to help sponsors and investigators comply with the new requirements for investigational new drug applications (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies was published by the FDA. The new requirements: (1) revise the definitions used for IND safety reporting; (2) clarify the submissions of IND safety reports; and (3) subject BA and BE studies to safety reporting requirements. The draft guidance provides examples and explanations of the definitions used for IND safety reporting, makes recommendations for determining when and how to submit a safety report, and provides advice on other safety reporting issues that have generated questions from sponsors and investigators. FDA Order, ¶40,406 and FDA Notice, ¶42,062

Live biotherapeutic products usage draft guidance published

A draft guidance titled “Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information_ published by the FDA provides investigational new drug application (IND) sponsors with recommendations on the submission of INDs for early clinical trials with live biotherapeutic products (LBPs). The draft guidance focuses on the chemistry, manufacturing, and control information that should be provided in an IND in order to meet the regulatory requirements for early clinical trials evaluating LBPs. The draft guidance is applicable to all INDs of LBPs, whether clinical trials are conducted commercially, in an academic setting, or otherwise. FDA Notice, ¶42,064