Last week Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA was cleared of a conflict of interest allegation. The charge came from her engagement of a firm developing a low molecular weight heparin generic, to find the source of the 2008 heparin contamination.
In 2008, Dr. Woodcock, and scientists at Momenta Pharmaceuticals were among a team of researchers that identified a contaminant in Chinese-imported heparin marketed by Deerfield, Illinois-base Baxter International that was sickening and, in some cases, killing patients. According to The Baltimore Sun, the findings were reported in a pair of science journals in April 2008.
In competition with Momenta to develop the drug was Amphastar Pharmaceuticals, Inc., located in Rancho Cucamonga. Both the version of heparin under development by Amphastar and Momenta is chemically similar but distinct from the form of the Baxter drug, according to the Sun.
Problems arose in April 2009, when Amphastar raised conflict allegations against Dr. Woodcock’s work with the drug. “Amphastar alleged that Woodcock’s research work with Momenta essentially forged a bond with the company and created the appearance of a conflict.” Amphastar also alleged in its complaint that “earlier contacts in 2007 between Woodcock and Momenta-connected scientists discussing issues that would later figure in requirements imposed on both companies’ applications.”
Eventually, Dr. Woodcock “voluntarily removed herself from considering the application, as well as a competing one filed by Amphastar Pharmaceuticals.”
Last week however, FDA legal counsel Ralph Tyler announced that “the research collaboration between Janet Woodcock, and scientists at Momenta Pharmaceuticals during the 2008 heparin crisis did not constitute a conflict, even though the drugmaker had an application pending before the agency.”
Mr. Tyler asserted that there was “no conflict” and that “as an act of good grace Woodcock stepped aside from any involvement in both applications last August.” In addition to this announcement, Mr. Tyler also acknowledged that the investigation by the Department of Health and Human Services Inspection General was dropped.
An attorney for Amphastar, Jason Shandell, was not happy with the announcement. He questioned the timing of Woodcock’s withdrawal from the study, and how the FDA contacted reporters before notifying his company. He asserted that that agency had handled the matter contrary to the “face of transparency” advocated by the Obama Administration.
In defending the stance of the FDA, principal deputy commissioner Josha Sharfstein told the Sun that “the agency needed to be able preserve its ability to respond to public health emergencies and also assure safety of new products.” Mr. Sharfstein further added that just because officials are involved in “both activities, does not mean they are automatically conflicted.
Ultimately, this case demonstrates an extremely important consideration: there is a difference between conflict and confluence.
In this case, it is clearly in the nation’s best interest that FDA officials have access to the most knowledgeable scientists to solve public health issues, and that means access to company scientists and technologies.