House Panel Joins Vioxx Inquiry

An influential House committee has joined in the congressional investigation of U.S. prescription drug safety, issuing extensive records requests Tuesday to the Food and Drug Administration and the drug manufacturer Merck & Co.

The House Energy and Commerce Committee said it was seeking to understand how the heart risks of Merck’s painkiller Vioxx were not addressed before the FDA approved the drug in 1999. Merck withdrew Vioxx from the market Sept. 30 after a company-sponsored study confirmed problems that critics had warned about.

The Energy and Commerce Committee has broad jurisdiction over the healthcare industry and a reputation for carrying out high-profile investigations of corporate and regulatory failures.

The request for documents was signed by the committee’s chairman, Rep. Joe Barton (R-Texas), and the panel’s ranking Democratic member, Rep. John D. Dingell of Michigan.

The FDA and Merck were asked to submit, by Dec. 7, volumes of documents that traced the drug’s history from development, approval by the FDA and use by patients. The agency and the company were asked to submit internal communications about possible safety problems.

There was no immediate response from the FDA or Merck, although the company has pledged to cooperate with official inquiries.

A spokesman said the committee was in a fact-finding stage and that hearings could follow early next year.

Several critics of the FDA have urged reforms to strengthen oversight of drugs already on the market, but the committee spokesman said no decisions had been made on whether legislation was needed.

Last week, an FDA drug safety reviewer, Dr. David J. Graham, told the Senate Finance Committee that the agency’s oversight had broken down and that there was no guarantee the public would be protected from medications with lethal side effects.