WASHINGTON—The collaboration between the Food and Drug Administration's top drug official and scientists for a pharmaceutical company on research during the 2008 heparin crisis – a time when the firm had a drug application pending -- did not constitute a conflict of interest, FDA legal counsel Ralph Tyler said Thursday.
But the drug official, Dr. Janet Woodcock, has voluntarily removed herself from consideration of the application by the company, Momenta Pharmaceuticals Inc., as well as of a competing application by Amphastar Pharmaceuticals Inc., Tyler said.
Amphastar, of Rancho Cucamonga, raised the conflict allegations in April 2009.
The two companies have been in bruising competition to develop a generic version of low molecular weight heparin, currently a $4 billion per year blockbuster marketed by Sanofi Aventis under the name Lovenox.
"We've determined that there's no conflict here," Tyler said, adding that as an "act of good grace" Woodcock had stepped aside from any involvement in either company's application since August 2009.
Tyler also said that an investigation by the Department of Health and Human Services Inspection General has been dropped.
Tyler's statements, made in a telephone call to The Times, were greeted with disbelief by an Amphastar attorney, who noted that the company received a letter from the FDA in September declaring that Woodcock had no conflict of interest.
"Why did she step aside right before they sent us a letter telling us that she has no conflict?," asked Jason Shandell. "And why didn't they tell us that she stepped aside?"
Shandell said FDA's handling of the matter, including contacting reporter about its resolution before notifying his company, "flies square in the face of transparency" advocated by the Obama Administration.
He said Amphastar has not decided how to respond to the FDA decision.
A spokeswoman for Momenta declined to comment. FDA declined to make Woodcock available for an interview.
Woodcock and several Momenta scientists 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. The findings were reported in a pair of science journals in April 2008.
The version of heparin under development by Amphastar and Momenta is chemically similar but distinct from the form of the Baxter drug.
Amphastar alleged that Woodcock's research work with Momenta essentially forged a bond with the company and created the appearance of a conflict.
In its complaint, Amphastar also cited earlier contacts in 2007 between Woodcock and Momenta-connected scientists discussing issues that would later figure in requirements imposed on both companies' applications.
FDA Principal Deputy Commissioner Joshua Sharfstein, who also participated in the telephone call, said the agency needed to be able preserve its ability to respond to public health emergencies, like the heparin crisis, while also assuring the safety of new drugs.
Officials who have involvements on both fronts do not necessarily incur conflicts, Sharfstein said. "It's not either or. We need to be able to do both," Sharfstein said.
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