Grassley To Propose Independent Drug Safety Board for FDA
Senate Finance Committee Chair Chuck Grassley (R-Iowa) said during a Consumer Federation of America meeting on Thursday that he is drafting legislation to create an independent FDA office to monitor the safety of drugs on the market and to warn the public of emerging risks, the Los Angeles Times reports. Grassley is collaborating with Sen. Christopher Dodd (D-Conn.) -- a member of the Senate Health, Education, Labor and Pensions Committee, which has direct jurisdiction over FDA -- to propose establishing an office headed by an independent director that would have the legal authority to require drug makers to alter prescribing information.
Grassley said he also is considering whether the office should have the power to suspend drug advertising or sales during an investigation. Grassley -- whose committee does not have direct authority over FDA -- has "hinted he may use his committee's jurisdiction over Medicare and Medicaid to force changes," the Times reports. Grassley said that FDA has become "too complacent" about safety and "too cozy" with drug companies. He said, "When the FDA approves a drug, it should be a Good Housekeeping seal of approval. Americans should be able to bank on the benefits outweighing the risks. Consumers shouldn't have to second-guess the safety of what's in their medicine cabinet."
Grassley added, "If you want accountability, it doesn't make sense to have the office that reviews the safety of drugs to be under the thumb of the office that puts the drug on the market in the first place" (Alonso-Zaldivar, Los Angeles Times, 3/11). "We need reforms, both administrative and legislative, to bring greater responsiveness and transparency to the FDA," Grassley said (Washington Post, 3/11).
Craig Orfield, spokesperson for HELP committee Chair Sen. Michael Enzi (R-Wyo.), said, "Enzi is not in favor of creating a separate (or) independent officer, either within or outside FDA" (Los Angeles Times, 3/11). Grassley said he plans to introduce the bill "in the next few days," CongressDaily reports.
Also during the meeting, Grassley said he has not decided whether to endorse FDA Acting Commissioner Lester Crawford as permanent commissioner of the agency. Grassley said that FDA "under (Crawford's) watch" was slow to publicly disclose information about an increased suicide risk in children who take antidepressants. He also noted that Merck, citing safety concerns, withdrew its COX-2 inhibitor Vioxx in September 2004 after it had been FDA-approved (CongressDaily, 3/10).
Grassley said that FDA has missed several deadlines to provide information related to COX-2 inhibitors in a finance committee investigation. Grassley said he was unsure whether Crawford should be confirmed "if he can't control these people down below that aren't responding" to the committee. Grassley said he will decide on his vote after the confirmation process (CQ HealthBeat, 3/10). The HELP committee had not set a date for the hearing (Congress Daily, 3/10).
An HHS spokesperson said, "Things have not changed as far as Dr. Crawford being an outstanding choice to be FDA commissioner. We're working with Sen. Grassley to fulfill his many requests" (CQ HealthBeat, 3/10).
In related news, 12 consumer groups on Thursday wrote to Crawford to demand that the agency "more closely scrutinize" the members of FDA advisory committees to "exclude those with close industry ties," Reuters/Washington Post reports. Among the groups sending the letter was the Center for Science in the Public Interest, which recently raised concerns about ties to industry among 10 members of the agency's COX-2 inhibitor advisory committee.
The letter suggested that the agency limit the number of experts with industry ties to half the number of panelists; bar from committee meetings any doctors or researchers who have a direct financial relationship to companies that would be influenced by their recommendations; post the names of proposed panel members 30 days before a scheduled meeting; and allow the public to comment on proposed members before a meeting. The letter states that FDA "must put an end to its promiscuous use of scientists with conflicts of interest and expand the public's opportunities to participate in the process" (Reuters/Washington Post, 3/11).