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Two leaders at the U.S. Food and Drug Administration (FDA) have recently found themselves in hot water at the agency. The director of drug approval has been named in an ethics investigation and a head medical device regulator has resigned.

The agency's director of the medical device division, Daniel Schultz, resigned yesterday after 15 years with the group. He had been accused of siding with industry suppliers, against scientific recommendations, during his five-year tenure leading the division, the Wall Street Journal reported today.

Schultz was involved in several controversial approvals, including a ReGen Biologics device used in knee surgery, which, according the Journal, had been permitted despite years of opposition from reviewers and scientists. Agency researchers reportedly described internal pressure to approve devices despite questionable safety or efficacy.

"There are too many devices on the market that are not proven safe and not proven effective," Diana Zuckerman, of the National Research Center for Women and Families in Washington, told Reuters.

Schultz said his departure "would be in the best interest of the center and the agency," an FDA memo said, according to the Associated Press. FDA Commissioner Margaret Hamburg named Jeff Shuren, the associate commissioner, as a temporary replacement.

Meanwhile, the FDA's head of drug evaluation is now under investigation by the Department of Health and Human Services' inspector general for a conflict-of-interest allegation.

While leading the drug evaluation and research division, Janet Woodcock has occasionally collaborated with a senior scientist from Momenta Pharmaceuticals, a company that is in competition with Amphastar Pharmaceuticals to gain approval for a generic version of the $3.5 billion-a-year blood-thinning drug Lovenox (sold by Sanofi-Aventis SA), the Journal reports.

Despite having filed for approval six years ago—two years ahead of Momenta—Amphastar's generic version of the drug has not yet been approved.

Amphastar representatives claim that competitors at Momenta have had special access to Woodstock, who appointed one of Momenta's founders, Ram Sasisekharan, to an FDA task force last year to investigate potentially contaminated heparin. Woodstock and Sasisekharan went on to help author journal articles that reported the findings, notes the Journal, the publication of which launched Momenta's stock 17 percent in just a day.

But company representatives told the Journal that Momenta, too, is suffering from the lengthy approval process yet still supports the agency's requirement of more data about both companies' drugs.

"I'm not sure why having lower [generic] standards would be in the public interest," Craig Wheeler, Momenta's chief executive, told the Journal.

Although the two staffing snafus seem to be isolated, the FDA has been a target of criticism this year, including scrutiny from the Obama Administration after a Salmonella outbreak and a late push to review older high-risk medical devices.

Image courtesy of the FDA via Wikimedia Commons

5 Comments

1. 1. anabolyst 07:32 PM 8/12/09

   Tends to confirm perceptions by non-scientists that scientific research is subject to the pressures of various interest groups and big industry. Science is a human activity and as such cannot escape the legacy of cultural and moral bias.

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2. 2. robert schmidt in reply to anabolyst 08:43 PM 8/12/09

   @anabolyst that science is under pressure from third parties that want specific outcomes to be confirmed is no surprise. That has always been the case. Over the past eight years, In an effort to increase personal profits and advance an archaic world view, the Bush administration has perpetrated some of the most grotesque manipulation and censorship of science in the modern age. Science itself is designed to compensate for the failings of mankind by standardizing and objectifying analyses but it cannot do this effectively when the watchdogs are corrupt and are acting on their own agenda. Fortunately, the US is not the only country doing science so the truth will eventually find its way out.
   
   The lesson here is not to distrust science but to be especially critical of "scientific" results that have either been created or filtered by Politicians or Commercial Interests. The mainstream media is also a terrible source of scientific information as their only interest is to sell papers so the more controversial the better, facts are irrelevant. At the same time, while a critical mind is healthy, a cynical mind is no better than a gullible one. Don’t let paranoia be your guide.The rule of thumb I try to follow is; the hypothesis I should be most critical of is the one I find easiest to believe.

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3. 3. Bops in reply to robert schmidt 03:31 AM 8/13/09

   robert schmidt,
   I agree with everything you said. The mess we're in is big. We need to set politics aside and work together.

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4. 4. Frosty46 06:01 AM 8/13/09

   Republicans, with their penchant for greed and corruption, are the black hole of knowledge and growth.
   The Bush years will be known later in human history as the second DARK AGES!

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5. 5. drafter 02:41 PM 8/13/09

   The BDS continues. This type of corruption occures all the time and during all administrations. there is nothing in this article that correlates to the Bush administration as being behind this and if you read the article the person under investigation got his start during the Clinton years and I won't blame him either because this person could have been acting on his own for all we know, so far.

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