Investigation Opened Into Possible Conflict Of Interest In FDA Case

August 12, 2009

US (ChattahBox) – A pharmaceutical company has accused a senior official within the FDA of a conflict of interest in an ongoing attempt for approval of a generic form of a multi-billion dollar blood thinner.

Amphastar Pharmaceuticals Inc. has accused Janet Woodcock, the director of the Center for Drug Evaluation and Research department, of unfairly fraternizing with a rival company also trying to get approval for a generic version of the drug Lovenox.

Woodcock co-authored a scientific article with someone within the rival company Momenta Pharmaceuticals Inc., and had regular contact with Professor Ram Sasisekharan, the founder of Momenta. This was all during the initial approval process, which Amphastar has alleged is an obvious conflict of interest.

Because of the continued contact of Woodcock and several people within Momenta, Amphastar officials are asking that the director recuse herself from the case.

“The FDA is aware of the situation, takes it seriously, and is looking into the matter,” a spokesperson for the organization was quoted in The Wall Street Journal.

A full investigation into the matter has been launched.


Comments

Got something to say? **Please Note** - Comments may be edited for clarity or obscenity, and all comments are published at the discretion of ChattahBox.com - Comments are the opinions of the individuals leaving them, and not of ChattahBox.com or its partners. - Please do not spam or submit comments that use copyright materials, hearsay or are based on reports where the supposed fact or quote is not a matter of public knowledge are also not permitted.