An FDA director has come under fire by a generics firm claiming that the director of the Center for Drug Evaluation and Research favored a competitor in a wanton act of conflict of interest. The Wall Street Journal this morning broke the story that Janet Woodcock is under investigation by FDA officials, and that an official ethics complaint has been filed against the director.
The generic firm leading the charge, Amphastar, submitted an application in 2003 for approval of a generic version of the blood-thinner Levenox. In 2007, FDA rejected the drug due to potential immunogenicity concerns.Â After sifting through public records, Amphastar discovered a conflict of interest between Woodcock and Momenta Pharmaceuticalsâ€”a rival firm that filed for a similar blood thinner two years after Levenox.
â€œIt appeared [that] one of the founders of Momenta and the vice president of Sandoz, in February of 2007, were working together to define the immunogenicity standards at MIT,â€ Amphastar spokesperson Dan Dichner told Pharm Exec. â€œThey sent these emails to Janet Woodcock urging FDA not to approve a generic equivalent hastily.â€
Additionally, Amphastar claims that during the heparin crisis Woodcock turned to Momenta to identify the contaminant instead of using its own internal labs. Both companiesâ€™ blood thinners include Heparin, but neither firm was found to have the tainted heparin in its drugs.
The clincher was that Woodcock penned journal articles for two publications in tandem with Momenta scientists, which, according to Amphastar, caused Momentaâ€™s stock to spike 17 percent.
â€œWe just summarized public information, and asked Woodcock to recuse herself from the review process based on this information,â€ Dichner said. â€œThe ballâ€™s in [FDAâ€™s] court. Weâ€™ve done everything theyâ€™ve asked. Weâ€™ve been inspected 12 times in the last year, which is unbelievable. The correspondence with the new leadership has been positive. They claim that they donâ€™t encourage these types of industry relationships, and we hope that thatâ€™s true.â€
FDA did not respond to comment by deadline.