Disclosure

Drug companies have the right to keep almost everything about their drug development efforts secret. Trade secret laws and FDA regulations:

• prohibit disclosure of proprietary information
• intended to protect corporate trade secrets and financial information
• permit FDA communication with drug's sponsor prior to approval prohibit FDA communication with the public, including patients and investors, prior to approval

End Result

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FDA regulations create an impenetrable shield behind which the FDA and drug companies hold their discussions. The FDA cannot correct misinformation or offer their perspective on problems in clinical trials to anyone without the drug company's permission. Examples:

• While FDA can halt a clinical trial for safety reasons, the agency cannot communicate directly with the patients in the trial.
• When FDA invites public comment at open meetings, briefing information for the meeting is not publicly available until 24 hours prior to the meeting. This makes it difficult for the public to provide informed comment.

Our Goal

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We challenge both Congress and the FDA to permit public disclosure at critical times in drug development for deadly diseases. When the FDA turns a drug down or stops a trial for a life-threatening disease, the public's right to know must take priority over the protection of proprietary or commercial interests.

First Step

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We urge the FDA to convene an advisory meeting to identify specific conditions — those involving rare situations in deadly diseases — where public disclosure would be a vital public service.

Our Efforts

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• Disclosure Fact Sheet from August 2001 FDA presentation (17K PDF file)
• April 5 2003 presentation by Nancy Roach, MNCF (46K PowerPoint presentation file)
• October 28 2002 letter to Wall Street Journal: Disclosure regulations keep the public out of the loop on all drugs. (HTML)
• April 3 2002 letter to FDA Commissioner requesting public consideration of the disclosure regulations (HTML)
• March 6 2002 letter to Wall Street Journal: Patients Shouldn't Have to Wait for Leaked Letters. (HTML)
• Requests to Representatives Tauzin and Greenwood, requesting consideration of disclosure regulations in the House Subcommittee on Oversight and Investigations hearings on ImClone:
  • Jan. 29, 2002 (20K PDF file)
  • Feb. 11, 2002 (22K PDF file)
  • June 18, 2002 (19K PDF file)