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FDA approves drugs even when experts on its advisory panels raise safety questions

BMJ 1999; 318 doi: (Published 03 April 1999) Cite this as: BMJ 1999;318:944
  1. Laurence Landow, Instructor in anesthesia, Harvard Medical School (
  1. Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA

    EDITOR—After reading the editorial questioning whether the Food and Drug Administration is approving drugs too fast I was perplexed by the conclusion—”probably not.”1 Apparently the authors failed to read the transcript of the meeting of the administration's advisory committee for mibefradil (NDA 20-689), which is on the administration's websiteK—one of three drugs recently recalled by the administration because of deaths and serious morbidity.

    If they had read this transcript they would have been overwhelmed by the …

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