Vioxx Case Puts Spotlight on FDA's Monitoring of Emerging Drug Side Effects
At a July 26, 2005 hearing before a House of Representatives appropriations subcommittee, Dr. Lester Crawford, the new head of the FDA, was criticized by several members of Congress over the Vioxx debacle. In particular, the lawmakers complained that it took the FDA 14 months to negotiate a new warning with Merck & Co. Inc. about cardiovascular risks linked to arthritis drug Vioxx. The Vioxx retrospective caused some members of Congress to propose legislation to bolster FDA authority so that they are able to mandate increased warnings on package insert labels more quickly.
In reaction to the suggestion that the FDA needs more power to order safety warnings on prescription drugs, Dr. Crawford -- who was confirmed as FDA commissioner just the week before this hearing (albeit, Dr. Crawford had been the acting commissioner for an extended period before) -- said he was "open to discussions on that, but we don't have any administration position" on that idea.
"The system works as it is," Dr. Crawford said several times, which drew this reply: "It shocks me to hear you say that. How can you say the system works?" said Rep. Maurice Hinchey, a Congressman from New York, adding, "You're not getting the job done." This prompted Dr. Steven Galson, acting director of the FDA's drugs center, to reply "we're not proud of how long (the Vioxx label change) took."
The Vioxx case has put a spotlight on the FDA's monitoring of emerging drug side effects. Since the Vioxx recall in September 2004, Dr. Crawford has repeatedly defended the FDA's performance. More recently, Dr. Crawford has asserted that newly formed drug safety board should work to make more drug-safety information available to the public. "I pledge to you we will be a much more transparent and open organization," he said. But Congresswoman Rosa DeLauro, of Connecticut, retorted "it flies in the face of openness" to keep private the business meetings of this new drug safety board. Moreover, DeLauro also said she was not satisfied with many of Crawford's responses to questions from lawmakers during the July 26 session. "It truly is difficult to get straight answers, Doctor Crawford. We are entitled to get answers," she said.
On the other hand, Congressman Henry Bonilla, the Texas Republican who chairs the House of Representatives appropriations subcommittee, came to Crawford's defense, saying that "the FDA has a very tough job" and that FDA staff generally "do a great job.
(Posted by: Tom Lamb)