Institute of Medicine to Advise FDA on Post-marketing Drug Safety Trials

Inspired by the Institute of Medicine's landmark report The Future of Drug Safety - Section 901 of the 2007 Amendments to the Food Drug and Cosmetic Act empowers the FDA to " require a responsible person for a drug to conduct a postapproval study or studies of the drug, or a postapproval clinical trial or trials of the drug...

‘‘(i) To assess a known serious risk related to the use of the drug involved.

‘‘(ii) To assess signals of serious risk related to the use of the drug.

‘‘(iii) To identify an unexpected serious risk when available data indicates the potential for a serious risk."

This new regulatory power is consistent with my 2007 article Punctuated Equilibrium.   I call for courts to recognize a negligence-based common law duty of "product stewardship" owed to consumers by manufacturers - to follow the actual impact of their drugs and medical devices when people start using them after marketing.  Post-approval study of actual conditions of patient use may yield or confirm effects only suspected (or slighted) by the product proponent while obtaining FDA approval to market.  


Now the FDA has asked the Institute of Medicine to advise it on practical implementation of the statuory grant of power.

Studies of Drug Safety and Post-Marketing Requirements

Type:

Consensus Study

Topics:

Quality and Patient Safety, Biomedical and Health Research

Boards:

Board on Population Health and Public Health Practice

Activity Description

The Food and Drug Administration has requested that the IOM convene a committee to evaluate the scientific and ethical issues involved in conducting studies of the safety of approved drugs.

Questions to be explored by a committee include:

1. What are the ethical and informed consent issues that must be considered when designing randomized clinical trials to evaluate potential safety risks?
2. What are the strengths and weaknesses of various approaches, including observational studies, including patient registries, meta-analyses, including patient-level data meta-analyses, and randomized controlled trials, to generate evidence about safety questions?
3. Considering the speed, cost, and value of studies, what types of follow-up studies are appropriate to investigate different kinds of signals (detected pre-approval or post-marketing) and in what temporal order?
4. Under what circumstances should head-to-head randomized clinical trials for safety be required?
5. How should FDA factor in different kinds of safety evidence in considering different kinds of regulatory actions?