GAO: FDA risked conflict during heparin scare
The U.S. government has just added its weight to the tug-of-war over generic versions of Lovenox. Momenta Pharmaceuticals ($MNTA) won the high-stakes race to sell its generic form of the Sanofi-Aventis ($SNY) blood thinner earlier this year, in partnership with the Novartis ($NVS) copycat drugs unit Sandoz. But that OK came only after conflict-of-interest accusations from other generics makers also seeking FDA approval for their Lovenox knock-offs.
As Amphastar Pharmaceuticals and Teva Pharmaceutical Industries ($TEVA) saw it, Momenta had a too-cozy relationship with CDER Chief Janet Woodcock in particular and the FDA in general. During the heparin scandal in 2008, Momenta pitched in on the investigation at no charge--at the same time the agency was considering its application to sell a Lovenox copycat. The agency investigated and recently announced that Woodcock had no financial conflicts in the generic-Lovenox review.
Now, however, Congress' watchdog group, the Government Accountability Office, says the agency's actions made it appear to show favoritism to Momenta, even if it really didn't. Momenta's free consulting work, coming at the same time as its application review, "ran the risk of undermining public confidence in the integrity of FDA's operations," the GAO says in a new report obtained by the Wall Street Journal.
Responding to GAO's report, the FDA told the Journal that it needed Momenta's help in identifying the source of heparin contamination that killed or seriously injured more than 100 people. But, the agency said, it should have considered the appearance of conflict--and should have done more to disclose the possibility.
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