FDA's Woodcock draws conflicts-of-interest probe

The FDA's drugs chief has found herself in the crosshairs of a conflict-of-interest probe. The Wall Street Journal reports today that the HHS inspector general is investigating allegations from Amphastar Pharmaceuticals, which claims that CDER director Janet Woodcock has been playing favorites.

Amphastar has been trying for six years to win approval for its version of Lovenox, the Sanofi-Aventis blood-thinner. Momenta Pharmaceuticals was aiming for the agency's OK at the same time (though Amphastar applied two years before Momenta did). And Amphastar alleges that Momenta had "special access" to Woodcock during the approval process, in part because she co-authored a scientific paper with Momenta scientists around the same time. After the paper appeared, Morgan Stanley touted Momenta's connection with the FDA as a "game-changer," sending the company's stock soaring 17 percent, the WSJ reports.

What does Amphastar want? For Woodcock to recuse herself from the approvals of Lovenox copycats. An FDA spokesman told the WSJ that that isn't happening: "The FDA is aware of the situation, takes it seriously and is looking into the matter."

- read the WSJ story [1] 

Related Articles:
FDA chief: Woodcock is a 'change agent' [2]
Momenta backs shorter data exclusivity period [3]
Momenta shares tumble after FDA rejection [4]
Momenta sees delay in generic Lovenox development [5]