Critics Question FDA's Fast-Paced Drug Approval Process
Kristin Jensen Bloomberg News, THE JOURNAL RECORD
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. …