John Dingell Blasts FDA’s Closed Culture at Today’s Committee Hearing on Drug Safety

If FDA's CMO Dr. Janet Woodcock's goal is to create an atmosphere at FDA in which scientific debate is encouraged, she appears to  have her work cut out for her. This morning, Congressman John Dingell had some harsh criticism for FDA and its Commissioner at the House Energy and Commerce Committe hearing on FDA and Drug Safety.  Citing recent whistleblower cases, he suggested that Dr. von Eschenbach has made it clear that the Agency "does not tolerate public dissent from FDA employees," but that "private dissent doesn't work, either," referring to recent Ketek incident.  Written testimony is not archived or available yet. However, a live videotape will soon be  available via this link. Below, Congressman Dingell's warm introduction:   Mr. Chairman, thank you for holding the second hearing in this Committees investigation of the handling of drug safety issues by the Food and Drug Administration (FDA). I welcome the FDA Commissioner, Dr. von Eschenbach, to the Committee. The Commissioner should know that the FDAs response to this Committees inquiries has been less than acceptable. Responses have been slow to our document requests regarding food safety, drug safety, and conflicts of interest. We do intend to see that all of our questions are answered fully. The Commissioners appearance today was preceded a month ago by former FDA staff members who testified that they were forced to flee the FDA because they feared retaliation from their superiors. These are good doctors and scientists that exposed bad decisions -- decisions that appear to have needlessly cost American lives. Both private statements and public quotes attributed to the Commissioner indicate that he does not tolerate public dissent from FDA employees. Private protests within the FDA do not appear to work either. For example, in the case of the drug Ketek, only after Congress was informed by FDA former employees of the confused dictates of senior FDA officials did the Agency finally rectify its mistakes. We have heard testimony that the Commissioner told these same employees that anyone not willing to be a team player would be traded. Given that their protests went to Congressional offices, including this Committee, I must remind the Commissioner that threatening FDA employees with retaliation for talking to Congress is not only unacceptable, it is illegal. My concern is echoed in a letter dated March 9, 2007, from Senator Chuck Grassley to Commissioner von Eschenbach, which I believe my colleagues should review. I ask that the letter be placed in the hearing record. Dr. von Eschenbach has been invited to tell us why the Agencys new Drug Safety Initiative will adequately address the cultural problems identified by a number of experts on FDA drug safety policies. That cultural problem comes down to what Senator Grassley calls having grown too cozy with industry “ preferring drug approvals over swift action when clear safety signals manifest post-market problems. At our last hearing, Dr. David Graham framed the question for todays hearing as What in the FDA proposals would prevent another Vioxx? For example, what in the new FDA proposal would ensure that FDA reviewers would not negotiate for more than 14 months on label changes, even after receiving substantial evidence of serious cardiac side effects as they apparently did with Vioxx? Would the newly proposed Office of New Drugs act any differently upon the clear warnings regarding Vioxx from the epidemiological work performed in the Office of Drug Safety? Under the new proposal, would the FDA medical officers in the Anti-Infectives Division been allowed to present their findings to the Advisory Committee? Under the new proposal, are the Advisory Committees more likely to hear about potential fraud or errors in pivotal safety studies? Moreover, where in the new FDA proposal is there any provision to fully inform the public of the case risks and benefits prior to a drugs approval? I, for one, do not see anything in the new FDA proposal that effectively responds to the many problems identified by this Committee over the last few years. None of these reforms impose structural guarantees to stop the cultural bias that has skewed the Agencys judgment. In the end, what the Administration proposal really boils down to is trust us. That would be easier to accept if the FDA and the Department of Health and Human Services were not resisting Congressional oversight and threatening whistle blowers. Regardless, drug safety continues to be the central concern of this Committee as the reauthorization of the Prescription Drug User Fee Act (PUDUFA) goes forward. And you can trust us that, with the strong support of my colleagues across the aisle, we will come up with legislative changes to ensure against another Vioxx. I thank both Chairman Stupak and Ranking Member Whitfield for holding this hearing, and I look forward to the testimony of todays witnesses.