FDA Drug-Approval Process Improving, GAO Study Finds

Congressional opponents of the Food and Drug Administration got more than they bargained for last month when Congress’ own watchdog agency released a study showing that the FDA’s much-criticized drug-approval process has improved measurably in recent years.

The General Accounting Office study found that from 1987 to 1992, the agency cut by 40% the time it takes to approve applications for new drugs. The average drug approval time dropped from 33 months in 1987 to just 19 months in 1992.

The study also found that total drug approval is typically faster in the United States than in Britain, where, over the five-year period, it took an average of 30 months to approve drugs, compared to 24 months in the United States.

The report was a bright spot for the FDA in what has been a rather bleak year. Republicans have criticized the agency as overzealous, and the pharmaceutical industry has accused the FDA of holding up breakthrough drugs and medical devices in unnecessary tests and trials.

The Republican-led Congress has made no secret of its hope to scrap the drug-approval system, cutting government regulation and slashing the agency’s budget. At least three plans are on the table to reform agency regulations on drugs, food and other consumer products. An estimated 25 cents of every consumer dollar goes for products requiring FDA approval.

The results of the GAO study are something of a vindication for FDA Commissioner Dr. David A. Kessler, who has been accused of poorly managing the agency.

“Clearly, this reflects well on Dr. Kessler,” said FDA spokesman Jim O’Hara. “The report shows what we’ve known for a while here: That the FDA is a world leader in its field.”

But the gloating didn’t last long after release of the GAO report. FDA officials were immediately back on the defensive as the pharmaceutical lobby teamed up with Republican lawmakers to take exception with the findings.

Gerald Mossinghoff, president of the Pharmaceutical Research and Manufacturers of America, or PhARMA, called the report misleading--citing contrary statistics from an industry-affiliated research center in England.

“According to the Centre for Medicines Research, for the past 10 years FDA review has averaged more than eight months longer than the review time in the U.K. [United Kingdom],” he said. Although the center receives its funding from the Assn. of the British Pharmaceutical Industry, its research is considered independent, said PhARMA spokesman Jeff Trewhitt.

Mossinghoff also took issue with the GAO’s methodology. “If total development time is taken into account, drug approval takes two years longer in the United States than in the United Kingdom,” he said.

The GAO report did find that total new drug development time--from the discovery of a compound through clinical testing--is increasing. The declining statistics mentioned above focus instead on the time it takes the FDA to OK a drug after a pharmaceutical company has developed it and submitted an application for approval.

But O’Hara argued that total drug development time has been increasing worldwide, due partially to the sophistication of drugs necessary to combat diseases like AIDS, cancer and Alzheimer’s. It is unfair to attack the FDA for delays throughout the drug development process, he said.

“When they say ‘total development time,’ they’re talking about discovery to marketing time, and all that the agency can really control is its review time,” O’Hara said. “We have been doing a very good job of implementing timely reviews, but we plan to do even better.”

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Congressional members from both sides of the aisle also were eager to put their own spins on the GAO findings. Sen. Nancy Landon Kassebaum (R-Kan.), who requested the report, fired off statements emphasizing that the findings show “more needs to be done” to improve the agency’s overall approval process.

Sen. Edward M. Kennedy (D-Mass.) called the report a “persuasive case against those who claim that Congress should scrap the current system of FDA review and replace it with a radically different approach.”