Drug Regulatory FDA publishes draft guidance for comments on Section 505(o) – Post marketing Clinical Trials

This guidance provides information on the implementation of new section 505(o) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355(o)), added by section 901 of the Food, and Drug Administration Amendments Act of 2007 (FDAAA). Section 505(o) authorizes FDA to require certain postmarketing studies and clinical trials2 for prescription drug and biological products approved under section 505 of the Act or section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262).

In the past, FDA has used the term postmarketing commitment (PMC) to refer to studies (including clinical trials), conducted by an applicant after FDA has approved a drug for  marketing or licensing, that were intended to further refine the safety, efficacy, or optimal use of a product or to ensure consistency and reliability of product quality. These PMCs were either agreed upon by FDA and the applicant or, under certain circumstances, required by FDA. Prior to the passage of FDAAA, FDA required PMCs in the following situations:

• Subpart H and subpart E accelerated approvals for products approved under 505(b) of the Act or section 351 of the PHS Act, respectively, which require postmarketing studies to demonstrate clinical benefit (21 CFR 314.510 and 601.41);
• Deferred pediatric studies, where studies are required under the Pediatric Research Equity  Act (PREA) (21 CFR 314.55(b) and 601.27(b)); and
• Animal Efficacy Rule approvals, where studies to demonstrate safety and efficacy in humans are required at the time of use (21 CFR 314.610(b)(1) and 601.91(b)(1)).

Section 506B of the Act provides FDA with additional authority to monitor the progress of a PMC by requiring the applicant to submit a report annually providing information on the status of the PMC.

New FDAAA Authority and Requirements

FDA May Require Applicants to Conduct Studies and Clinical Trials. Section 505(o) of the Act authorizes FDA to require postmarketing studies or clinical trials at the time of approval or after approval if FDA becomes aware of new safety information.

Applicants Are Required to Report on the Status of Studies and Clinical Trials, this information must include:

• a timetable for completion
• periodic reports on the status of the study, including whether any difficulties in completing the study have been encountered, whether enrollment has begun, the number of participants enrolled, the expected completion date.

The Guidance goes on in detail to discuss the regulations and how the FDA intends to interpret them, this guidance is for comment and the FDA would like to hear from you.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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