F.D.A. Official Admits 'Lapses' on Vioxx

By GARDINER HARRIS

Published: March 2, 2005

WASHINGTON, March 1 - After the Food and Drug Administration insisted for months that it did nothing wrong in its oversight of the withdrawn pain pill Vioxx, a top agency official acknowledged "lapses" in the agency's actions before a Senate panel on Tuesday.

The official, Dr. Sandra Kweder, deputy director of the office of new drugs at the agency, also said the power to require label changes "would be very helpful."

Most witnesses testifying before the panel, the Senate Committee on Health, Education, Labor and Pensions, agreed, saying the agency should have the authority to force label changes and make companies conduct tests if safety issues arose after a drug was approved.

Dr. Steven Galson, the director of the new drug center, said after the hearing that the F.D.A. had not requested new authority over labels.

Dr. Kweder said the agency took too long to get information about Vioxx's heart risks into the prescribing label that is provided to physicians. More than a year passed between an advisory panel's conclusion that those risks should be highlighted and the label changes, she said.

Dr. Kweder blamed difficult negotiations with Vioxx's maker, Merck, for the delay. "We don't have the authority to tell a company, 'This is how your label has to look,' " she said. "We have to negotiate with the company the specific language of how things should be worded, the placement, those kinds of things, after talking to them."

The other lapse, Dr. Kweder said, was "the failure of that information somehow to be in the forefront of the consciousness of the prescribing physician."

Millions of people took Vioxx in the years after its risks to the heart became apparent. As a result, as many as 55,000 patients may have died from heart attacks and strokes induced by the drug, according to estimates by drug safety officials at the F.D.A. Merck withdrew the drug from the market in September, after a test showed that it doubled the risk of heart attack and stroke.

Dr. Kweder's admission could cause difficulties for Merck, which is battling more than 800 lawsuits filed by thousands of patients claiming that they were injured by Vioxx.

Casey Stavropoulos, a Merck spokeswoman, responded, "We worked diligently with F.D.A. to do all requested analyses and develop labeling that provided physicians with the most accurate and appropriate information."

An F.D.A. advisory panel concluded last month that Celebrex and Bextra, similar pills made by Pfizer, also cause heart problems. The panel concluded that all of these drugs should have labels with strong warnings about their heart risks.

Senator Michael B. Enzi, a Wyoming Republican who is chairman of the health committee, said he had not decided what changes, if any, he would propose for the agency. But he said examining problems at the F.D.A. was "not only critical, but it's also a hot issue right now."

Senator Patty Murray, Democrat of Washington, asked Dr. Kweder during the hearing if Merck had rejected F.D.A.'s initial proposals to warn of Vioxx's heart risks on its label. "They rejected many of our proposals, and we similarly rejected many of the proposals they sent to us," Dr. Kweder said.

The negotiations began in February 2001 and were not resolved until April 2002, a period that Dr. Kweder said was unusually long. "Usually it's just a matter of a few back-and-forths and getting the language right," she said.

Dr. Kweder also said the Bush administration's proposal to add $5 million to the agency's budget in the 2006 fiscal year for tracking the safety of drugs once they are approved represented "a good down payment."

The F.D.A. has almost no ability to uncover dangers once drugs are approved if risks are common problems like heart attacks, top agency officials have said. Every witness who went before the panel on Tuesday said the agency must do a better job of uncovering such dangers using existing computer databases.

One witness argued that the agency did not need more power. Dr. Scott Gottlieb, a former top official at the agency who is now at the American Enterprise Institute, a conservative research group, said the agency "doesn't use its existing authority very well."

Dr. Gottlieb said that the agency's initial proposals to change drug labels often "aren't worded very well," and that they improve greatly after suggestions from drug companies.

William Schultz, another former top official at the F.D.A., said the agency should be given the power to limit or ban drug advertising for a period after a drug's initial approval and limit prescriptions of some medicines to certain specialists.