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Stride For Life

FDA Public Disclosure Regulations:
Serving the public? Or drug companies?
"People shouldn't have to wait for leaked letters to understand what the bureaucracy is up to ..." 
— Wall Street Journal, Feb. 27 2002

FDA Mission:

Promote the public's health by promptly and efficiently reviewing clinical research and ensure that drugs are safe and effective. Subset of FDA Mission Statement,

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:

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:

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:

This is a complex issue which needs examination by FDA, patients, industry and researchers. 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. In addition, we urge the FDA to set an aggressive timeline for this examination.

Our efforts:

Wall Street Journal letter dated Feb. 7 2002; includes a summary of the ImClone story

Requests to Representatives Tauzin and Greenwood, requesting consideration of disclosure regulations in the House Subcommittee on Oversight and Investigations hearings on ImClone:

Request to FDA Commissioner Lester Crawford dated April 3 2002, requesting public consideration of the disclosure regulations.

Wall Street Journal letter dated October 2002: Disclosure regulations keep the public out of the loop on all drugs.

In addition, we've had meetings with FDA officials and members of Congress to explore ways to change the disclosure regulations. Stay tuned …

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