Acting FDA Commissioner Offers To Meet With Sen. Chuck Grassley on Intimidation Allegations
Acting FDA Commissioner Lester Crawford on Friday offered to meet with Senate Finance Committee Chair Chuck Grassley (R-Iowa), who has been FDA's "most vocal congressional critic" since an agency "whistleblower" testified that senior agency officials had attempted to intimidate him after he expressed early concerns about Merck's withdrawn painkiller Vioxx, the Washington Post reports (Washington Post, 12/4).
Last month, David Graham, associate director of drug safety in the FDA Office of Drug Safety, testified before the Senate Finance Committee that Merck should have withdrawn Vioxx from the market years earlier and criticized agency actions related to the medication. He also said that FDA, "as currently configured, is incapable of protecting America against another Vioxx" because of ties between agency reviewers and the pharmaceutical industry.
Since his testimony, Graham has said he is facing pressure to change jobs within FDA as a retaliatory measure for his remarks before a Senate Finance Committee hearing on the Vioxx withdrawal. Graham said that he informed Crawford that he was not interested in the new assignment. However, Graham added that he recently heard unofficially that he will be required to accept the new assignment as soon as this week.
In addition, Tom Devine, legal director for the Government Accountability Project -- which is providing legal counsel to Graham -- said that soon after Graham retained GAP attorneys, the group received anonymous phone calls from FDA phone numbers attempting to discredit Graham by accusing him of scientific misconduct.
Grassley called on HHS' Office of Inspector General to investigate Devine's allegations. Grassley last week sent a letter to Crawford requesting that he "address allegations that administrative action may be taken against Dr. Graham, including that he may be terminated or transferred against his wishes to a job other than conducting scientific research" (California Healthline, 11/30).
Crawford on Friday replied to the letter, saying FDA respects "the rights of all employees," adding, "I take all of your concerns very seriously" (Washington Post, 12/4).
Sandra Kweder, director of the FDA Office of New Drugs, on Saturday said that FDA should open its methods to greater public scrutiny, listen to its critics "and be able to respond to their criticism."
Kweder -- responding to an editorial in which BMJ stated, "Something is rotten at the heart of the FDA" -- said the agency "realizes there are a lot of concerns out there about how good a job we are doing of monitoring drug safety" and noted that "the public wants more information." Kweder added, "We have historically done our job by monitoring what's going on and only making announcements when we reach conclusions. But what we are hearing is that there are lots of people who want to be informed along the way about our thinking about particular drugs and potential safety issues."
Larry Sasich of Public Citizen said FDA and the drug industry have become partners in approving new drugs, adding that more oversight is needed over the agency's practices. "One of the things that needs to be changed is for Congress to have regular oversight hearings," Sasich said (Nesmith, Austin American-Statesman, 12/5).
The following are summaries of recent articles that address issues surrounding FDA.
- The Baltimore Sun on Monday looked at how Graham has become an "accidental celebrity" in the three weeks since his Senate testimony, during which time he has lost about 10 pounds and "none of his supervisors has so much as spoken to him" (Kohn, Baltimore Sun, 12/6).
- The New York Times on Monday looked at how FDA has "shifted gears" since the White House and Congress in 1992 "forced a marriage" between the agency and the drug industry, in which drug makers give FDA "millions" that the agency spends in part to fund new drug approvals. FDA's Center for Drug Evaluation and Research last year spent 79% of its budget on new drug reviews, compared with 53% in 1992, and the agency now "has almost no ability" to perform post-approval tests on drugs or "uncover the kind of life-threatening drug side effects that sidelined Vioxx," the Times reports (Harris, New York Times, 12/6).
- The Times on Monday also examined how advertisers and drug makers -- which spend $3.8 billion annually on direct-to-consumer advertising -- "are increasingly concerned" about their ability to reach patients and doctors as "doubts" about drug marketing are "fueled by the intensifying firestorm surrounding Vioxx." While critics have said consumers have in the past "unfairly favor[ed] newer prescription brands over older ones," studies show a declining level of consumer response to direct-to-consumer advertising, which could be evidence of "a potentially momentous change from current attitudes," the Times reports (Elliott, New York Times, 12/6).
NPR's "Talk of the Nation/Science Friday" included a discussion of prescription drug safety. Guests on the program included Jerry Avorn, author of a book titled, "Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs" and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital; Catherine DeAngelis, editor in chief of the Journal of the American Medical Association; and Brian Strom, professor and chair of the Department of Biostatistics and Epidemiology at the University of Pennsylvania School of Medicine (Flatow, "Talk of the Nation/Science Friday," NPR, 12/3). The complete segment is available online in RealPlayer.This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.