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Comments from the Survey by CDER&CBER Scientists

doi: 10.1097/01.COT.0000295014.57924.e8

Of the 997 scientists who participated in the survey, half wrote narratives in addition to answering direct questions. The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are where oncology drugs are evaluated, studied, and regulated. Following are some comments in the respondents' own words:

  • “The Commissioner's office should be depoliticized. The number of political appointees and related staff has ballooned in the last five years.”
  • “Keep political influence out of here.”
  • “My boss said to me, ‘If you don't approve this application, I am going to reassign it to another medical officer.’”
  • “Computer simulations using clearly erroneous models have been used to approve drugs for political reasons.”
  • “Twice in the past month, a Division Deputy Director stated during a meeting that they were approving a drug, regardless of the medical and statistical review, without ever looking at the data.”
  • “Advisory committee members should be selected on scientific grounds without political influence.”
  • “I've been here over 20 years, and this is the worst. Science is being ignored or abused. Get politics out of here.”
  • “About advisory committee meetings: I've observed that [FDA] management and companies have found ways to manipulate this process in favor of approval. These methods are very subtle and would not easily be recognized, for example: (1) A Division Director may think that a particular person on the committee has a strong opinion because of his or her expertise, and if the Director is worried that the person may vote against a drug, he or she can schedule the committee meeting when the person in question cannot attend. (2) A drug company can hire as consultants just about every expert on the topic being discussed, so there are no expert consultants available to FDA. The company also can hire advisory committee members themselves, thus creating a conflict of interest and making the consultant ineligible to participate in the meeting. (3) A Division Director or Office Director can change the content of the committee meeting briefing document so that potentially damaging but factual information is not included. (4) Management can pressure FDA reviewers to soften their committee presentations.”
© 2006 Lippincott Williams & Wilkins, Inc.
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