After Criticism, FDA Will Strengthen Drug Safety Checks

As part of its effort to strengthen safety monitoring, the FDA will establish a formal program for agency scientists who disagree with decisions about specific drugs. The scientists will be able to present their views to a panel of FDA and outside experts, who will be required to come back with a recommendation within 30 days.

In addition, the FDA will contract with the National Academy's Institute of Medicine for a review of the safety system and an assessment of how it can learn more about potential harmful side effects before drugs become widely used. While defending the FDA's safety record, Galson said that the agency would be open to recommendations for changes.

Public health advocates generally supported the FDA's initiatives, but Sam Kazman, the chief counsel of the Competitive Enterprise Institute, a nonprofit public policy organization dedicated to the principle of limited government, said that the proposals were potentially harmful to the public health. He said he feared the agency would slow its drug review process and possibly keep useful drugs off the market.

"There's a real danger that the Vioxx situation will make the agency less willing to take any risk," he said. "Historically, the agency suffers from deadly overcaution rather than recklessness and has only been coming out of its shell in recent years. We don't want them to retreat again."

The controversy surrounding the withdrawal of Vioxx has battered Merck, which has long had the reputation of being one of the most ethical drug companies. Merck's stock closed at $26.21 Friday, down 81 cents or 3 percent for the day and down nearly 42 percent since Vioxx was withdrawn.

Merck officials declined to comment on the FDA's reform proposal, but they argued that the agency's initial news releases about the Vioxx withdrawal were very supportive of Merck's handling of the drug.

"Now people are looking at this through the prism of hindsight, and there are people with agendas who leak information to influence the process," said general counsel Kenneth C. Frazier.

Frazier and chief Merck spokeswoman Joan Wainwright said the company continues to believe it handled Vioxx appropriately. They said the company followed the FDA's guidelines for advertising and pointed out that the company promptly shared all its Vioxx studies -- including the 2000 study that first suggested a heart attack risk -- with the public.

"I think we still are the good drug company. We still have the same ethics," Wainwright said. "Is [the negative publicity] something I like to see every day? No, but it doesn't change the fundamentals of the company."

Merck is facing hundreds of lawsuits from Vioxx users who claim the drug harmed their health. Judges in the California and New Jersey state courts have already ruled that Vioxx-related lawsuits can be treated as class actions involving hundreds of plaintiffs. Hundreds of plaintiffs' lawyers are scheduled to gather next week in Las Vegas to coordinate efforts to bring additional cases in federal and state courts.

An estimated 20 million Americans have taken Vioxx since the drug was approved, making the number of potential plaintiffs enormous. Some Wall Street research analysts have put Merck's potential liability at more than $10 billion, fueled in part by an FDA study that estimated Vioxx could be responsible for 27,000 deaths and the conclusion in this month's Lancet, a British medical journal, that the drug should have been pulled in 2001.