FDA official cleared of conflict-of-interest allegations in heparin case
A research collaboration between the Food and Drug Administration’s top drug official and a pharmaceutical company during the 2008 heparin crisis did not constitute a conflict of interest, FDA chief counsel Ralph S. Tyler said in an interview Thursday.
But the official, Dr. Janet Woodcock, voluntarily removed herself from consideration of a pending 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-of-interest allegations in April. The FDA rejected the complaint, and last month Amphastar said it had asked the agency to reconsider. The FDA’s latest pronouncement was that it had rejected Amphastar’s request.
The two companies are vying to develop a generic version of a type of heparin, a $4-billion-per-year blockbuster marketed by Sanofi-Aventis under the name Lovenox. Heparin, an anticoagulant, is primarily used to prevent blood clots.
“We’ve determined that there’s no conflict here,” Tyler said, adding that as an “act of good grace” Woodcock had stepped aside in August from involvement in both companies’ applications.
Tyler also said that an investigation by the Department of Health and Human Services’ inspector general had been dropped.
Woodcock and several Momenta scientists were among a team of researchers who identified a contaminant in heparin imported from China that was sickening, and in some cases killing, patients. Their findings were reported in two science journals in April 2008.
Amphastar alleged that Woodcock’s research with Momenta essentially forged a bond with the company and created the appearance of a conflict of interest.
Amphastar also cited contacts between Woodcock and Momenta-connected scientists in 2007, when they discussed issues that would figure in requirements imposed on both companies’ heparin applications.
Tyler’s statements Thursday, made in a telephone call to The Times, were greeted with disbelief by an Amphastar attorney, who said the company had not been notified by the FDA of its recent decision, but had received a letter from the agency 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 the FDA’s handling of the matter, including contacting a reporter before notifying his company, “flies square in the face of transparency” advocated by the Obama administration. The September letter said Woodcock had no financial tie with Momenta, and therefore no conflict of interest. Amphastar asked the FDA to reconsider.
“This was an appearance issue, an appearance of impropriety,” Shandell said.
Amphastar has not decided how to respond to the FDA decision, he said.
A spokeswoman for Momenta declined to comment.
The FDA declined to make Woodcock available for an interview.
FDA Principal Deputy Commissioner Joshua Sharfstein, who also participated in the telephone call Thursday, said the agency needed to preserve its ability to respond to public health emergencies, such as the heparin crisis, while ensuring the safety of new drugs.
Officials who are involved on both fronts do not necessarily incur conflicts of interest, Sharfstein said.
“It’s not either or,” he said. “We need to be able to do both.”
