The US Food and Drug Administration’s Janet Woodcock is under investigation for an alleged conflict of interest involving two generic drugmakers and approval of their drugs.
An official ethics complaint has been filed against the Director of the FDA’s Centre for Drug Evaluation and Research by Amphastar Pharmaceuticals, the Wall Street Journal has reported.
The California-based generics firm claims approval of its generic version of Sanofi-Aventis’ blockbuster blood thinner Lovenox (enoxaparin) has been delayed by six years, while the company’s competitor, Momenta Pharmaceuticals, has had “special access” to the Director during the drug approval process of its generic version of Lovenox, which it submitted for approval two years later.
Amphastar claims Woodcock co-authored two journal articles with Momenta scientists during the same time the company was aiming for drug approval. The company also says one of the founders of Momenta, Ram Sasisekharan, was appointed to lead an FDA task force in 2008, which Amphastar claims put Momenta in constant contact with the FDA.
Amphastar applied for approval of its generic drug in 2003, while Momenta did not submit applications for approval until two years later. However, the FDA rejected Amphastar’s application in 2007 citing more data was required but Momenta also had to submit additional data based on immunogenicity concerns.
An FDA Spokesman told the WSJ: “The FDA is aware of the situation, takes it seriously and is looking into the matter”.
Meanwhile, the Administration’s top medical device regulator Daniel Schultz is reported to be resigning after internal issues.
