FDA more cautious about drug safety

Recent withdrawals put approval, monitoring process under scrutiny

April 17, 2005|By Susan Baer | Susan Baer,SUN NATIONAL STAFF

WASHINGTON - Not so long ago, the Food and Drug Administration could be counted on to approve a new drug or medical device - and approve it with some speed - if its advisory committee recommended it do so.

But these days, facing intense scrutiny, political pressure and criticism that it has rushed harmful drugs to market and cozied up to the pharmaceutical industry, the agency appears to be adopting a more cautious, conservative stance and shifting its calculus in evaluating a drug's risks versus its benefits.

Because of high-stakes, high-profile controversies over the safety of arthritis drugs such as Vioxx and antidepressants prescribed for teenagers, the FDA has recently taken a tougher stand on a number of drugs.

Early this month, it pressed Pfizer to pull its arthritis drug, Bextra, off the market. It required severe safety warnings on nearly all anti-inflammatory drugs, including such popular over-the-counter medications as Aleve and Motrin. In March, it required two popular topical treatments for eczema to carry a "black box," the strongest warning available, advising consumers of a possible link to cancer even though the data are far from clear.

Whether the FDA will follow last week's recommendation by an advisory panel to allow certain silicone breast implants back on the market is anyone's guess - but certainly not a slam-dunk in the current climate.

"You're seeing a very typical pendulum reaction," says Arthur A. Levin, director of the Center for Medical Consumers and a member of the FDA's advisory panel on Drug Safety and Risk Management. He is heartened by the more cautious approach. "Where there's uncertainty, you err on the side of safety. That's not the rule usually."

William B. Schultz, a Washington lawyer and former deputy FDA commissioner for policy, says the underlying current in the agency's approach these days appears to be a desire to get longer-term data in evaluating the safety of drugs.

Indeed, the cardiovascular problems associated with Vioxx didn't show up in studies until after 18 months of use. Similarly, the agency found that the ruptures and other problems from silicone breast implants typically occurred after three years.

Last week, the FDA panel evaluating silicone implants made by two Santa Barbara, Calif., companies rejected an application by one company, Inamed, saying the manufacturer needed to present longer-term safety data.

But Schultz says it is not clear the FDA will follow the advice of its panel to allow implants made by a rival company, Mentor, back on the market. In late 2003, the last time the agency considered silicone implants, the FDA staff "expressed a lot of doubts about the data," Schultz said. This time around, the companies did not provide that much more proof of safety than they had before.

"Vioxx was a wake-up warning," says Schultz. "The absence of problems isn't enough. You have to have a strong showing of safety."

But not everyone thinks erring on the side of caution is a move in the right direction. "People tend to think caution is a good thing," says Sam Kazman, chief counsel of the Competitive Enterprise Institute, a public policy group that advocates free enterprise and limited government. "If you're drowning and I'm about to throw you a rope, but people want to first see the paperwork on that rope, by the time I get that rope to you, you may be gone."

Kazman says the FDA is reverting to what he calls "deadly overcaution" and bowing to political heat in the aftermath of unexpected side effects in some widely used drugs. "The flip side is that people don't get the medicines they need," he says.

He would like to see the agency transformed from what he calls a "veto agency" into an advisory agency in which doctors would be allowed access to unapproved therapies as long as they and their patients understood the risks.

The Pharmaceutical Research and Manufacturers of America, which represents most brand-name drugmakers, has also expressed concern about the recent drug withdrawals. "It's important to make sure the benefits of a product are given equal weight as the risks," says spokesman Jeff Truitt. "It's patients who benefit from the products."

He says he hopes the FDA does not get "stampeded into hasty, premature action" to reform its drug approval process in response to the recent, highly publicized problems.

Kathleen K. Quinn, a spokeswoman for the FDA, says the agency is approaching decisions on drug approvals as it always has: "Do the benefits outweigh the risks for the intended use in the intended population?"

But she notes that the agency is trying to evaluate its procedures in a number of ways and is awaiting the recommendations of the Institute of Medicine, which is reviewing the FDA's drug safety system, especially for drugs already on the market.

For much of its recent history, the nearly century-old FDA was criticized as too sluggish in approving new drugs.

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