GAO says FDA mishandled Lovenox-copy review

The U.S. government has just added its weight to the tug-of-war over generic versions of Lovenox.

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