Devices & Diagnostics

Turmoil at the FDA? — MedCity Morning Read, Aug. 13, 2009

The inspector general of the U.S. Department of Health and Human Services is investigating a conflict-of-interest allegation involving the nation’s top drug regulator, Janet Woodcock, according to the U.S. Food and Drug Administration. On Tuesday, the FDA’s top medical-device regulator, Daniel Schultz, said he would resign “by mutual agreement” with FDA Commissioner Margaret Hamburg.

WASHINGTON, D.C. — The inspector general of the U.S. Department of Health and Human Services is investigating a conflict-of-interest allegation involving the nation’s top drug regulator, Janet Woodcock, according to the U.S. Food and Drug Administration, the Wall Street Journal said.

The investigation of Dr. Woodcock, the director of the FDA’s Center for Drug Evaluation and Research and a 23-year veteran of the administration, started with an ethics complaint by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year quest to win approval for a generic form of Lovenox, a multi-billion-dollar blood thinner, the Journal said.

In its complaint, Amphastar said its competitor had special access to Woodcock at critical times during the prolonged approval process, which is ongoing, according to the Journal. Amphastar also points out that Woodcock co-authored a paper with scientists at Momenta Pharmaceuticals Inc. while both companies were battling to win FDA approval for their generic blood thinners, the Journal said.

Momenta says the co-authored paper represents a conflict of interest and asked that Woodcock excuse herself from the blood thinner approval process. The FDA says it’s aware of the complaint, but Woodcock had not removed herself from the process, the Journal said.

On Tuesday, the FDA’s top medical-device regulator, Daniel Schultz, said he would resign “by mutual agreement” with FDA Commissioner Margaret Hamburg, according to the Wall Street Journal.

The departure follows internal dissent over device approval decisions that the regulators’ critics say were too friendly to the industry, the Journal said. An FDA spokesman said Schultz’s resignation has nothing to do with device approvals. Dr. Schultz had worked at the FDA’s Center for Devices and Radiological Health for 15 years and led it for the last five years, the Journal said.

Sen. Chuck Grassley, an Iowa Republican, held hearings two years ago on Schultz’s approval of a nerve stimulation device to treat depression over the objections of several FDA doctors, according to the Journal.

More stories worth a read: