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

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 …