PharmExec Blog

Woodcock Under Investigation

WASHINGTON - APRIL 29:  Janet Woodcock, direct...
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An FDA director has come under fire by a generics firm claiming that the director of the Center for Drug Evaluation and Research favored a competitor in a wanton act of conflict of interest. The Wall Street Journal this morning broke the story that Janet Woodcock is under investigation by FDA officials, and that an official ethics complaint has been filed against the director.

The generic firm leading the charge, Amphastar, submitted an application in 2003 for approval of a generic version of the blood-thinner Levenox. In 2007, FDA rejected the drug due to potential immunogenicity concerns.  After sifting through public records, Amphastar discovered a conflict of interest between Woodcock and Momenta Pharmaceuticals—a rival firm that filed for a similar blood thinner two years after Levenox.

“It appeared [that] one of the founders of Momenta and the vice president of Sandoz, in February of 2007, were working together to define the immunogenicity standards at MIT,” Amphastar spokesperson Dan Dichner told Pharm Exec. “They sent these emails to Janet Woodcock urging FDA not to approve a generic equivalent hastily.”

Additionally, Amphastar claims that during the heparin crisis Woodcock turned to Momenta to identify the contaminant instead of using its own internal labs. Both companies’ blood thinners include Heparin, but neither firm was found to have the tainted heparin in its drugs.

The clincher was that Woodcock penned journal articles for two publications in tandem with Momenta scientists, which, according to Amphastar, caused Momenta’s stock to spike 17 percent.

“We just summarized public information, and asked Woodcock to recuse herself from the review process based on this information,” Dichner said. “The ball’s in [FDA’s] court. We’ve done everything they’ve asked. We’ve been inspected 12 times in the last year, which is unbelievable. The correspondence with the new leadership has been positive. They claim that they don’t encourage these types of industry relationships, and we hope that that’s true.”

FDA did not respond to comment by deadline.

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