Journal Commentary Labels FDA 'Timid and Toothless'

New England Journal of Medicine article claims agency too tied to industry

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HealthDay Reporter

WEDNESDAY, March 16, 2005 (HealthDay News) -- The U.S. Food and Drug Administration continues to sweat under the spotlight as a commentary in the prestigious New England Journal of Medicine accuses the agency of seeming "timid and toothless."

The article, by Dr. Susan Okie, a contributing editor to the journal, appears in the March 17 issue of the publication.

The FDA and the drugs it approves have been under scrutiny for months. Two episodes have drawn particular attention to the agency. In September, the makers of the painkiller Vioxx removed the drug from the market following the revelation it had negative effects on the heart. And there has also been criticism of the FDA's slowness in acknowledging studies linking adolescent use of antidepressants to an increased risk of suicidality.

These controversies, Okie wrote, "have raised questions about the agency's ability to fulfill one of its fundamental missions -- to ensure that the benefits of prescription drugs outweigh their risks."

But, according to the article, the FDA's problems go beyond this to include questions of post-marketing drug safety monitoring, lack of leadership, pressure to approve new drugs quickly and dubious ties to industry.

It hasn't always been this way, she said. "Earlier, it functioned as a pretty effective regulatory agency," Okie said. "It had a much more watchdog posture vis-a-vis the pharmaceutical industry."

What changed?

Part of the problem has been leadership, or lack thereof, Okie claimed. The FDA has lacked a permanent leader for most of the time George W. Bush has been in the Oval Office, since Dr. Mark McClellan, who served from November 2002 until March 2004, was never replaced. Dr. Lester Crawford has served as acting commissioner for a total of almost three years before and after McClellan. Last month, he was nominated to fill that position permanently.

Before McClellan, Okie pointed out, the FDA's highest-ranking appointed administrator was Daniel Troy, who had represented tobacco and drug companies in suits against the FDA's proposed regulation of tobacco and restrictions on the promotion of drugs for unapproved uses.

"You have an administration that is very pro-business, anti-regulatory, and there's been a tendency to manage all of these agencies from the top with a kind of pro-business stance," Okie said.

The Prescription Drug User Fee Act (PDUFA), which Congress passed in 1992 and which requires pharmaceutical companies to pay fees to the FDA, may also have contributed to changes. While the act was initially a response to complaints about the slowness of the FDA's approval process, many critics say it has speeded things up too much.

"PDUFA fees tie the agency to that source of revenue," Okie said. "There's more of a rush to move on things and, I think, more of a client relationship with the pharmaceutical industry."

One scientist, Elizabeth Barbehenn -- who worked for the agency for 13 years -- told Okie, "We were on the clock. We had just so much time to get a review done." Another (unnamed) scientist said that when he first joined the FDA 15 years ago, "there was an absolute emphasis on safety. It is very, very clear that the emphasis now is getting drugs approved."

Along with the emphasis on speed came a discouraging of internal dissent. In February 2004, one medical reviewer was prevented from presenting his findings linking the use of antidepressant drugs in youth with increased suicidality, and FDA whistleblower Dr. David Graham was told to alter the conclusions of his Vioxx study.

Recently, however, there have been some signs of hope in the agency, according to Okie. One of those is the nomination of Crawford to head the agency. "If the new commissioner takes a more activist role and is allowed to take more of a leadership activist role, that could change a lot of things," she said. "A strong leader would do a lot."

Also, Graham's superiors at the FDA allowed him to present his findings on Vioxx at the FDA advisory committee hearings on cox-2 inhibitors.

Health and Human Services Secretary Mike Leavitt has also announced his intention to establish a new Drug Safety Oversight Board within the FDA. This news has been met with mixed feelings as many feel that such an entity needs to be housed outside the agency.

"It's supposed to have some degree of independence, but would still be part of the FDA," Okie said. "A lot of people feel it would be better to have an independent agency outside the FDA to look at drug safety. Setting up an independent agency will seriously get considered. There will be a lot of debate over this next year or two."

The FDA did not respond to a request for comment.

More information

The U.S. Food and Drug Administration has more on the current drug approval process.

SOURCES: Susan Okie, M.D., family physician, Bethesda, Md., and contributing editor, New England Journal of Medicine, Boston; March 17, 2005, New England Journal of Medicine

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