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Should FDA's Complete Response Letter Be Public Knowledge?


A paper published in the British Medical Journal, authored by FDA staff, compares content from FDA's complete response letter for a rejected drug, with the subsequent press release by drug developers.

A paper published in the April issue of the British Medical Journal, by staff from FDA's Office of Public Health Strategy and Analysis, compared the content of the complete response letter issued by the FDA when they disapprove a product marketing application, with subsequent press releases by the drug developers. The complete response letter is not made public.

For this study, 61 complete response letters issued by the Center for Drug Evaluation and Research were compared with the complementary press releases by the drug sponsor. The study found that while nearly 50% of complete response letters pointed to safety and efficacy problems with the product, no press release was issued subsequent to 18% of the complete response letters. When a press release was issued, 21% did not match any statements from the letters issued by the regulatory body. While merely 14% of press releases matched wording from the letters, 16% addressed efficacy and 15% included language on safety concerns in the letter. Of the press releases subsequent to complete response letters calling for clinical trials to address safety and efficacy issues, 59% had statements matching those in the letter. Finally, the study found, that while 7 of the 61 completer response letters pointed to high mortality rates in the participants, only 1 press release drew attention to the fact of mortality.

The authors conclude that while several drug developers did not issue a press release consequent to receiving a complete response letter from the FDA, those who did omitted important information on safety and efficacy mentioned in the letter. "Press releases are incomplete substitutes for the detailed information contained in complete response letters," they write. Public knowledge of why a drug application was rejected, according to the authors, would better inform the development of new drugs, allow public dialogue, and avoid misconceptions on FDA’s reasons for denial of applications.

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