Conflicts brewing at the FDA

The US Food and Drug Administration's chief drug approver has been hit with allegations of a conflict of interest, and the head of the agency's division on medical devices is resigning amid claims that he was making decisions that betrayed close ties to industry.Image: FDA linkurl:Janet Woodcock,;http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/FacesBehindCriticalPath/ucm077470.htmthe director of FDA's Center for Drug Evaluation and Research, has apparently landed under

Bob Grant

| 2 min read

Image: FDA

linkurl:Janet Woodcock,;http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/FacesBehindCriticalPath/ucm077470.htmthe director of FDA's Center for Drug Evaluation and Research, has apparently landed under the microscope of the inspector general in the Department of Health and Human Services (HHS) at the behest of California-based drug maker Amphastar Pharmaceuticals, linkurl:according;http://online.wsj.com/article/SB125003545637224263.html?mod=googlenews_wsj to __The Wall Street Journal__. The company, which manufactures the popular over-the-counter asthma medication Primatene Mist, alleges that Woodcock is playing favorites with another drug company, Boston-area Momenta Pharmaceuticals. Amphastar's complaint involves a 2008 linkurl:paper;http://content.nejm.org/cgi/content/abstract/358/23/2457 about contaminated lots of the blood thinner heparin. Woodcock coauthored that article, which was published in the __New England Journal of Medicine__, with Momenta scientists and other researchers. Momenta was asked by the FDA to help in investigating tainted shipments of heparin from China. Amphastar claims that Woodcock's connection to Momenta is garnering the East Coast company special access to the FDA regulator in the ongoing approval process for competing blood thinners made by the two companies. The two drugs, both generic versions of Sanofi-Aventis's blockbuster blood thinner Lovenox, are currently under consideration for approval at the FDA. Amphastar is asking that Woodcock recuse herself from the approval process due to her links with Momenta, according to a spokesperson for the company. "She should step aside from this review process," he told __The Scientist__. In late 2007, the FDA rejected Amphastar's application, telling the company that it needed to submit more safety data concerning the drug's immune system effects. Amphastar submitted its application for approval in 2003, and Momenta submitted an application in 2005. Momenta, too, was asked to provide additional safety data. Mark Wolfson, spokesperson for the HHS's Office of the Inspector General, told __The Scientist__ that he could neither confirm nor deny that an investigation of Woodcock was taking place. But an FDA spokesperson told __The Scientist__ that the agency is looking into the matter. "We are aware of some complaints by Amphastar, we're taking these very seriously, and we're taking a look at them," he said. On Tuesday, the FDA's top medical device regulator, Daniel Schultz, announced his resignation after FDA scientists claimed he pressured them into approving certain products against their professional judgment.
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[February 2008]

Conflicts brewing at the FDA

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