Docket No. FDA-2009-D-0283
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Posted at: http://www.regulations.gov
Public Citizen has reviewed the draft guidance in detail and supports its purpose and approach.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 We urge you to resist any efforts to weaken the draft guidance.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, M.D., M.P.H.
Sidney M. Wolfe, M.D.
Health Research Group at Public Citizen