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Regulatory Update, April 2016

Friday, April 1, 2016

Final FDA Guidance on Safety Data Collection in Late-stage Clinical Investigations

In the February 19, 2016 Federal Register, the FDA announced the availability of a fi­nal guidance document titled “Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations.” The guidance is intended to help sponsors determine the amounts and types of safety data to collect in late-stage premarket and post-approval clini­cal investigations (e.g., phase III clinical trials, studies of new uses, long-term outcomes) based on what is al­ready known about a drug’s safety pro­file. Sponsors collect extensive safety data in clinical investiga­tions of drug and biological products conducted to sup­port marketing ap­proval (premarket) and after approval (postapproval). The FDA believes that selective safety data collection may be possible for some late-stage premarket and postapproval clini­cal investigations because certain aspects of a drug’s safety profile will be sufficiently well-established and comprehensive data collec­tion is not needed. This guidance makes final the draft guidance issued in February 2012.

If the drug’s safety profile is well-estab­lished before completion of clinical develop­ment or for marketed drugs used in post­marketing clinical trials, it may no longer be necessary in some cases to collect certain types of safety data. In some cases, collec­tion of data that do not contribute to better characterizing the safety profile of a drug may have negative consequences. Addition­ally, excessive safety data collection practices may discourage the conduct of certain types of trials by increasing the resources needed to perform the trials and might also be a disincentive to investigator and patient par­ticipation in clinical trials. The FDA believes that selective safety data collection may (1) facilitate the conduct of larger trials without compromising the integrity and the validity of trial results or losing important informa­tion, (2) facilitate investigators’ and patients’ participation in clinical trials and (3) help contain costs by making more-effi­cient use of clinical trial resources.

This guidance outlines the circum­stances where selec­tive data collection may be appropri­ate and the types of safety data that may be eligible for selec­tive collection. The guidance provides recommendations on maintaining a balance between eliminating the collection of data that will not be useful and collecting sufficient data to allow adequate characterization of the safety profile of a drug in scenarios where selec­tive safety data collection is appropriate. The guidance also strongly encourages sponsors to work closely with the relevant FDA review division or divisions to establish and imple­ment selective safety data collection.

Interested parties may submit comments on final guidance documents at any time. Submit electronic comments as described above. Identify comments with Docket No. FDA-2012-D-0096.

Draft FDA Guidance on Inhalation Anthrax Prophylaxis

In the February 16, 2016 Federal Regis­ter, the FDA announced the availability of a draft guidance for industry titled “Anthrax: Developing Drugs for Prophylaxis of Inha­lational Anthrax.” The purpose of this draft guidance is to assist sponsors in the devel­opment of new drugs to be administered to persons who have inhaled Bacillus anthracis spores, but who have not yet manifested clini­cal evidence of disease, to prevent develop­ment of inhalational anthrax disease. The FDA refers to this indication as “prophylaxis of inhalational anthrax.” This draft guidance describes approaches for the designs of the animal model efficacy studies and recognizes that drug development for the sole indication of prophylaxis of inhalational anthrax is pos­sible. This draft guidance supersedes the draft guidance for industry titled “Inhalational Anthrax (Post-Exposure) — Developing Antimicrobial Drugs,” published in March 2002. The 2002 draft stated that drugs for the prophylaxis of inhalational anthrax would be approved under the accelerated approval regulations unless the drug already carried an anthrax indication. Shortly after the 2002 draft guidance issued, the FDA amended its regulations to provide a regulatory mecha­nism to approve drugs and biological prod­ucts when human efficacy studies are not ethical or feasible. These regulations are com­monly referred to as the “animal rule.” This draft guidance states that drugs developed for prophylaxis of inhalational anthrax will be considered for approval under the animal rule regulations. Submit electronic or writ­ten comments by April 18, 2016 as instructed above and identify them with Docket No. FDA-2016-D-0412.

The Regulatory Update is excerpted from Re­search Practitioner, Volume 17, Number 2, Mar.-Apr. 2016.

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