Is Amphastar's allegation that FDA CDER chief Janet Woodock has a conflict of interest in looking at its generic Lovenox application genuine or just the maneuvering of a disaffected company that has spent six years failing to get its product through the FDA?
Amphastar applied for a generic Lovenox approval in 2003, two years before Momenta submitted a similar application, the WSJ reports. Neither drug has been approved. Between then and now, Woodcock tapped Momenta founder Ram Sasisekharan for one if its task forces:
... to lead an FDA task force in early 2008, which put him and Momenta in regular contact with the agency. That task force was investigating tainted Chinese-made heparin, a crisis that led to nearly 100 deaths.
Drs. Woodcock and Sasisekharan, along with other Momenta scientists, then co-authored two medical journal articles last year identifying the cause of the contaminated Chinese heparin imports, a finding that won scientific -- as well as Wall Street -- kudos for Momenta.Amphastar alleges that Momenta's unusual access to Woodock during the heparin flap has given Woodock a conflict that favors Momenta over Amphastar.
UPDATED: In a response to BNET's request that it release copies of Amphastar's complaint, FDA said: "FDA can neither confirm nor deny an investigation. As a rule, the agency takes all conflict of interest allegations seriously and deals with them appropriately." If Amphastar's accusations are true, it looks like a firing offense -- the company is essentially suggesting that its application was deliberately delayed for years because Woodcock liked the folks at Momenta better.
Given Woodcock's career at the FDA, that scenario seems unlikely. As the WSJ points out, Woodock has not even been asked to recuse herself while the probe takes place. And even if Woodock does recuse herself, which is all Amphastar is asking happen, how does that help Amphastar? Not much.
Eric Varma - Leerink Swann: And could you comment on where your competitors are generic Lovenox like Teva, Amphastar?
CEO Craig Wheeler: We really can't. I think we have the same information that our investors have at this point and so we really don't know.There are three other variables to consider: One is that Woodock is a re-appointee of the old Bush-era FDA commissioner Andrew von Eschenbach. Second, Woodcock was considered for the FDA commissioner's job and didn't get it. And third, the new FDA commissioner, Margaret A. Hamburg, recently gave a speech in which she hinted that she didn't think much of the old FDA:
In recent years, the Government Accountability Office and others have suggested that the FDA's enforcement efforts may not have always lived up to these principles.
Reports have noted that there has been a steep decline in the FDA's enforcement activity over the past several years. At the same time, many of the enforcement actions that the FDA has undertaken have been hampered by unreasonable delays.None of that directly reflects on Woodcock, of course. But it suggests that life inside the FDA is a lot more complicated than it needs to be.