Merck & Co.’s internal documents about the marketing of the Vioxx painkiller suggest the company may have downplayed the heart risk that later caused the drug’s withdrawal, the House Committee of Government Reform said Wednesday.
The committee today is holding a hearing in Washington about Merck’s marketing of Vioxx and the Food and Drug Administration’s oversight of the company. The House panel said it requested and received from Merck documents about how its more than 3,000 sales representatives promoted Vioxx to doctors.
“A review of the documents supplied to the committee raises questions as to whether Merck was presenting a fair and balanced presentation to physicians on the safety of Vioxx,” the House panel said in a statement posted on its Web site.
Congress has been examining for months whether the FDA and Merck should have done more to warn consumers about Vioxx’s heart risk before the Sept. 30 withdrawal of the drug. The House committee said the hearing today also will examine whether the structure of the FDA’s Center for Drug Evaluation should be changed in response to the Vioxx withdrawal.
The center includes both the Office of New Drugs, or OND, which is responsible for approving medicines, and the Office of Drug Safety, which is responsible for monitoring the risks of drugs sold in the United States.
“During the committee investigation, internal problems between OND and ODS became clear,” the House committee said.
Two senators, Republican Charles Grassley of Iowa and Democrat Christopher Dodd of Connecticut, introduced a bill on April 27 that would create a separate center within FDA for monitoring the safety of drugs.
The FDA declined to comment on the government reform committee’s statement before the hearing, said Suzanne Trevino, an agency spokeswoman.
Merck declined to comment on the House committee’s agenda and report beyond a prepared statement.