FDA taken to task for Vioxx recall handling
United States Senator Charles E. Grassley, Chairman of the Senate Finance Committee is taking a very strong stance on how FDA has handled the Vioxx recall issue. In a previous letter to Office of Inspector General (OIG), Department of Health and Human Services, he had requested that he conduct a complete and thorough investigation into the facts, events, persons, policies, regulations and laws relating to allegations that a number of management level employees at the FDA may have acted to discredit Dr. David Graham who was challenging the FDAs drug safety policies. (Related article: Senator Grassley demands investigation into harassment of FDA critic)
On November 18, 2004, in his opening comments at the Committee's hearing related to Vioxx, Senator Grassley stated that, "[T]he clarifications provided last night by Dr. Crawford appear intended to intimidate a witness on the eve of a hearing. . . . Dr. Crawford knows there's a problem and would better serve the FDA by spending time on the problem, rather than going after congressional witnesses who helped identify the problem in the first place."
As is being reported in several newspapers, rumors have been circulating that the top brass at the FDA is not pleased with Dr. Graham's statements, particularly those that talk about how dysfunctional the organization is and how as many as five drugs on the market may not really be safe. In his harshly worded letter to Crawford, Grassley asks him to cooperate fully with the investigation into the complaints, and adds, "I have requested that FDA employees be advised that they may come to Congress and speak freely without fear of reprisal. Do you believe that FDA employees are free to speak to members of Congress without advising FDA's Office of Legislation? If so, when are you going to act on this request?" He has also directed that all FDA employees must be told about this investigation and be notified that all records and documents relating in any manner whatsoever to this investigation, either directly or indirectly, must be preserved immediately.
It is since being reported that Crawford will be meeting with Grassley to address the concerns raised by the Senator.
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