PhRMA'S Citizen's Petition

The Pharmaceutical Research and Manufacturers of America last week filed a Citizens' Petition asking the FDA to reconsider its final regulation requiring product sponsors to disclose the financial interests of investigators involved in clinical studies.

The regulation requires sponsors filing marketing applications with the FDA on or after Feb. 2, 1999, to provide disclosure of all payments made to clinical investigators and subinvestigators participating in trials that support the application, no matter where or when conducted...