Allegations of Conflict Dog FDA Official Over Generic Heparin Drug

Washington, DCIn a pharmaceutical world bedeviled by drug side effects, drug defects and even medical device safety inherent with products put out by medical device companies, the US Food and Drug Administration (FDA) has at various times found itself called out for everything from lax oversight to slow response times.

Now there are conflict of interest allegations against the director of the FDA's Center for Drug Evaluation and Research. The inspector general of the Department of Health and Human Sciences is investigating.

The allegation was lodged by Amphastar Pharmaceuticals Inc. the California company is of the view that Dr. Janet Woodcock collaborated with a competitor and thus entered into a conflict.

At the heart of the issue are approvals for a generic version of Lovenox, a form of heparin. Amphastar has been trying to win FDA approval for its formulation for six years.

A competitor, Momenta Pharmaceuticals Inc. is also seeking FDA approval for a generic version of the low-molecular-weight heparin. Lovenox is a biologic drug that realized global sales of $3.5 billion last year.

The Wall Street Journal reported August 12th that Amphastar's application was rejected in November 2007. At the time the FDA told Amphastar that while the application was successful in demonstrating chemical equivalency to Lovenox, the agency required more data to show that the generic drug would not cause dangerous immune reactions.

Momenta was asked to submit the same data.

What lay behind the allegation of conflict was the appointment of Dr. Ram Sasisekharan, a biological engineering professor with the Massachusetts Institute of Technology, to an FDA task force studying tainted heparin from China.

Dr. Sasisekharan is also a founder of Momenta. Drs. Woodcock and Sasisekharan, together with a handful of other Momenta scientists, went on to co-author two medical journal articles in 2008 that identified the Chinese heparin contaminant.

The finding, according to the Wall Street Journal won praise for Momenta. An April, 2008 investment report from Morgan Stanley summed up Momenta's connection with the FDA as a "game-changer" and Momenta's stock jump 17 percent in a single day.

While the FDA encourages publication in journals with noted scientists, it is unusal for FDA officials to co-author journal publications with industry researchers. In this instance, the co-authorship happened in the midst of a drug approval process.

Momenta has gone on record as saying contact between Momenta and Dr. Woodcock has been appropriate.