Critics question FDA's fast-paced drug approval process

WASHINGTON -- The record number of drug recalls in the United States in the past year probably won't slow down approvals for new treatments.

American Home Products decided last month to remove Duract, a pain reliever, from pharmacy shelves less than a year after it was introduced, due to toxic effects on the liver that may have played a role in four deaths. It was the sixth withdrawal of a drug due to safety concerns in the last 12 months, after only 10 between 1980 and 1996.

The recalls put pressure on the U.S. Food and Drug Administration. Congress last year told the agency to accelerate its approval process. Now, critics of the FDA worry that there will be more cases like Duract and claim that the agency, which approved 92 new drugs in the past two years compared to about 25 annually in the past, doesn't screen new drugs carefully enough.

"We're going to see a lot more of this," said Raymond Woosley, chairman of the pharmacology department at Georgetown University. "When we're doubling the number of new drugs approved every year, there will be problems that will show up."

The FDA and its supporters counter that many side effects are so rare they don't emerge in clinical trials, no matter how thorough they are. Also, new drugs may interact with other therapies in unforeseen ways. This underscores the need to monitor drugs closely once they go on sale.

The number of drug withdrawals actually proves that the monitoring system works, they claim.

"A recall isn't a sign that anybody made a mistake, it's a sign that there's increased scientific knowledge about a product," said Richard Samp, general counsel for The Washington Legal Foundation and a sometimes ardent FDA critic.

Common sense suggests that if more new drugs are approved, more will be recalled. A side effect that only occurs in about 1 in 10,000 patients will sometimes be missed in clinical studies.

"It isn't like the FDA has been asleep at the switch all these years," said Ira Loss, an analyst who covers the FDA for HSBC Washington Analysis, a division of HSBC Securities.

The agency has identified dangerous risks from some blockbuster drugs, such as Warner-Lambert's diabetes drug Rezulin, Johnson & Johnson's heartburn drug Propulsid and potent HIV treatments made by Agouron Pharmaceuticals, Merck, Abbott Laboratories and Roche Holding.

The benefits of those drugs are so powerful, however, the agency chose to strengthen their warning labels to highlight concerns rather than pull them off the market entirely.

"For serious and life-threatening illnesses, we're willing to take a higher safety risk," said Murray Lumpkin, deputy director of the FDA's Center for Drug Evaluation and Research.

The FDA's critics complained for years that other countries had access to new therapies first.

In the past, many drugs were on the market in Europe and elsewhere before winning approval in the United States. Sometimes they turned out to be too dangerous and drugmakers withdrew them before they were ever sold in the United States.

Now, Americans are getting the benefit of first access to many new drugs and they, instead of the Europeans, are the guinea pigs for their first large-scale use. It's a mixed blessing, because some risks only emerge with wide use of a drug.

"We're willing as a country, Congress said, to take the chance that there will be unfortunate side effect developments in some products" in return for faster approvals, said HSBC's Loss.

Roche's Posicor drug for high blood pressure, for example, was prescribed to some 200,000 Americans before the FDA and company decided its potential to dangerously interact with other drugs was too great and Roche removed the drug from the market in June.

Vermont Republican Sen. James Jeffords, chairman of the Senate committee that oversees the FDA, is investigating how the FDA monitors new drugs and may hold hearings. He isn't questioning the review process itself, however.

"We don't think that the problem is that drugs are being pushed out on the market too quickly," said Joe Karpinski, spokesman for Jeffords. "You always have to keep remembering drugs are potentially dangerous -- that's why they are administered under the supervision of a trained professional."

In fact, Congress passed its FDA overhaul bill last year just weeks after the notorious withdrawal of two diet drugs.

The sudden, wide-scale use of American Home's fenfluramine, an obesity drug, in an unapproved combination with another drug, phentermine, in the popular "fen-phen" diet treatment, and the quick sales of American Home and Interneuron Pharmaceutical's Redux left thousands of patients subject to potential heart-valve problems.

The FDA recommended the recall of the drugs in September and the companies promptly complied.

Like Roche's Posicor, Hoechst's allergy drug Seldane was withdrawn from the market earlier this year because of the risk from interaction with other drugs.

Pfizer's Viagra, the first pill to treat impotence, met with unprecedented demand when it was introduced in April. From the start, the blockbuster drug had a strong warning not to use it together with nitrate heart medicines. The drugmaker reinforced the warning about nitrates with letters to physicians after reports of deaths of men who had taken Viagra.

Prescriptions for Viagra slowed down after the reports, though there was no evidence directly linking the drug to any deaths. The recalls of Posicor and Duract in June also may have dampened enthusiasm for Viagra and other new drugs.

"There's no question recalls are a negative," said Martin Bukoll, an analyst with Northern Trust, which owns several drug stocks.

"It's not going to stop this great engine of industry growth, but it particularly could dampen new products' growth and acceptance."

Copyright 1998
Provided by ProQuest Information and Learning Company. All rights Reserved.