Now, some manufacturers are complaining to Wall Street that the FDA began slowing drug approvals to a crawl last year, reluctant to let new medicines sell for fear of more such problems.
Who is right?
The latest government records show no major slowdown: Breakthrough drugs still are speeding through the FDA. One, a major advance in leukemia therapy called Gleevec, even set a record this spring when it won FDA approval in less than three months.
Total approval time, counting less important drugs and breakthroughs, did go up by four months last year. But that was largely because long-languishing products like the abortion pill RU-486, which the FDA delayed for four years until its sponsor found an acceptable manufacturer finally were approved, skewing the statistics.
Plus, there are not many breakthroughs each year. Drug companies actually are sending fewer novel medicines to the FDA today, instead creating more "me-too" drugs similar to ones already sold. Federal law gives the FDA longer to review those kind of drugs.
"We're not slowing down," said the FDA's drug chief, Dr. Janet Woodcock.
She challenged the industry to create more groundbreaking medicines.
In 1999, half the drugs the FDA approved were priority drugs, breakthroughs or medicines deemed to advance public health. Last year, just one-third were. The agency expects to receive applications for just 28 entirely new chemicals this year, 15 fewer than in 1998.
"That's not our slowdown," Woodcock said. "We're sitting here with open arms."
Still, some recent high-profile rejections such as the experimental treatment Zelnorm for irritable bowel syndrome suggest the FDA is being more cautious.
Some FDA watchers say that is because drug makers may over-promise products to investors and patients in some cases touting drugs with clear regulatory problems.
A report by the investment research company UBS Warburg cited some evidence the agency is taking a tougher stance on safety.
"However, it could be argued that companies had been adopting a more laissez-faire attitude with the FDA," it says, adding: "A cynic might suggest that it is easier to blame the FDA than admit that the clinical information submitted was not adequate."
Ira Loss, a pharmaceutical analyst at HSBC Washington Analysis, says some companies "began to think that anything you throw at FDA they're going to approve, and some of them started throwing anything there. If it doesn't work, the FDA's not going to approve it."
Last year, the median approval time for priority drugs was six months, unchanged since the late 1990s.
Overall drug approval time was 15.6 months, up from 11.6 months in 1999.
The drug industry's main trade group agrees the FDA did not appreciably slow own last year. But the Pharmaceutical Research and Manufacturers of America group is tracking this year's approvals to see if reviews are lagging.
A separate look at biotechnology drugs shows these more complex products have taken longer than regular pharmaceuticals to be approved.
Median approval time for biotech drugs went from 11.5 months in 1998 to 16.5 months in 1999, and rose by an additional month last year.
Biotech review chief Robert Yetter attributes the 1999 jump to companies submitting applications before they finished properly studying the medicines.
The FDA scheduled 1,000 meetings with companies last year to improve understanding of federal requirements and avoid incomplete applications.
Amgen Inc., the world's largest independent biotechnology company, got an initial thumbs down from the FDA earlier this year for its prostate cancer drug Abarelix, and has found approval taking longer than expected for the anemia treatment Aranesp.
"We are frustrated, no doubt about it," Amgen chief executive Kevin Sharer said recently. "It is taking too long."
Some drug makers cite a variety of recent rejections in complaining the FDA is too harsh. Among them:
- The FDA is requiring more safety testing of Novartis' Zelnorm because a small number of patients using it needed gall bladder surgery, a possible red flag. The only other irritable bowel treatment, Lotronex, was pulled last winter after causing at least four deaths from a different abdominal problem. Separately, Novartis withdrew its application to sell the drug in Europe after regulators there questioned its effectiveness.
- Pfizer Inc. is delaying filing its application for inhaled insulin called Exubera. The FDA almost certainly would have demanded more safety data to explain a puzzling study conclusion four times as many diabetics who inhaled Exubera developed antibodies against insulin than did diabetics who injected insulin.
- The FDA is delaying approval of Clarinex, a successor to the popular allergy pill Claritin, until maker Schering-Plough Corp. addresses federal violations at its manufacturing plants.
By Lauran Neergaard
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