• Worst Pills, Best Pills



• Health Letter



• Health Links



• Activist Courses



• Take Action!



• Drug Safety



• Healthcare Delivery



• Medical Devices



• Food Safety



• Occupational Health

Comments on FDA Draft Guidance on Postmarketing Studies and Clinical Trials (HRG Publication #1894)

October 13, 2009

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Posted at: http://www.regulations.gov

Comments on FDA Draft Guidance “Postmarketing Studies and Clinical Trials--Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act.” (Docket No. FDA-2009-D-0283)

Public Citizen has reviewed the draft guidance in detail and supports its purpose and approach. The guidance makes a sensible distinction between studies that are for efficacy purposes only (“postmarketing commitments”; these may be recommended but not required) and those that have any significant safety element (“postmarketing requirements”; these may be required). The categories of studies that can fall under postmarketing requirements (observational studies, clinical trials, animal studies, in vitro studies, pharmacokinetic studies, and interaction/bioavailability studies) are appropriately broad. We urge you to resist any efforts to weaken the draft guidance.

Peter Lurie, MD, MPH
Deputy Director

Sidney M. Wolfe, MD
Director
Health Research Group at Public Citizen

more resources

Because Public Citizen does not accept funds from corporations, professional associations or government agencies, we can remain independent and follow the truth wherever it may lead. But that means we depend on the generosity of concerned citizens like you for the resources to fight on behalf of the public interest. If you would like to help us in our fight, click here.