The FDA's approval of copycat Lovenox has now spawned two lawsuits. The latest comes from Amphastar Pharmacteuticals, one generics maker that didn't win the agency nod. It is accusing the agency of holding up imports of raw heparin earlier this year, interfering with its application for approval.
Previously, Amphastar accused the FDA of playing favorites with Momenta Pharmaceuticals, the company whose partnership with Sandoz won the race for agency approval earlier this year. Amphastar said the agency was biased, at least in part because of a previous working relationship between CDER chief Janet Woodcock and Momenta's chief scientist. As the Wall Street Journal notes, FDA has since cleared Woodcock of any financial conflicts of interest.
Now, Amphastar alleges that FDA's decision to stop its raw heparin shipments is part of a pattern of "arbitrary, capricious and vindictive behavior" on the agency's part. Amphastar also accuses FDA of scheduling more than a dozen inspections, specifically to harass the company.
The FDA wouldn't comment for the Journal. But the agency has been policing heparin shipments more thoroughly in recent months because of 2008's contamination scandal.
- read the WSJ piece