Advisory info may jeopardize trade secrets

Medical Marketing and Media, Jun 2000 by Dickinson, James G

Public disclosure of information packages provided to advisory committee members prior to a panel meeting could jeopardize trade secret and confidential/ commercial information, industry argues in recently released comments to the FDA. The comments are in response to an agency draft guidance entitled Disclosing Information Provided to Advisory Committees ..., and warn that, if adopted, the FDA could be in violation of the 1905 Trade Secrets Act.

PhRMA contends that many items identified by the FDAs guidance as releasable are exempt from disclosure under the Freedom of Information Act. Merck warns that sponsors would no longer provide much of the "detail and issue-oriented information previously provided in confidential packages."