The bad blood between rival drug developers Amphastar and Momenta has bubbled over into public view. Questions over the firms' competing franchise for a generic version of the blockbuster blood thinner Lovenox has led to allegations of misconduct at the FDA, the hiring of a prominent security firm to investigate those accusations and the announcement of a Congressional investigation into the hiring of said security company.

Amphastar and Momenta are both seeking approval to sell a their own version of the blood thinner heparin. While the companies are neck-in-neck for approval, Amphastar actually applied two years ahead of Momenta. The years of regulatory delays, while billions of dollars hang in the balance, have seen the competition between the two pharmaceutical companies turn decidedly ugly. Squabbling over the fairness of the FDA's drug approval processes has led to charges of favoritism.

Amphastar has gone so far as to file a complaint alleging that Momenta had received preferential treatment from Janet Woodcock, director of the FDA/s Center for Drug Evaluation and Research. The Amphastar complaint sought Woodcock's recusal from the proceedings, and cited supposed special access to Woodcock enjoyed by Momenta and the fact that Woodcock had co-autored a scientific paper with Momenta researchers during the period both companies were pursuing FDA approval for their generic version of the blockbuster blood thinner.

For its part, Momenta contends that the contact with the FDA has been appropriate and that Momenta has certainly lobbied the government to utilize a higher standard for approving a heparin generic - one that presumably Momenta would be able to meet, but Amphastar might not. The FDA has seemed responsive to Momenta's line of argument citing evolving science and the complexity of the drugs in question.

The FDA has defended its neutrality, noting that their calls for more details on immune reactions affected both drug makers.

Not content with the FDA's administrative investigation into Woodcock (the FDA will not even confirm such an investigation) Amphastar sought outside help from noted investigative firm, Kroll. That move has caught the attention of senators Max Baucus and Chuck Grassley. The two informed Amphastar of their probe in late September via a joint letter, citing concerns over a drug company hiring an outside firm to investigate a Federal regulatory agency.

We'll see what comes of it...

Labels: Amphastar, Kroll, Momenta