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By Herb Newborg

FDA Device Chief Quits as Ethics Probe Targets CDER Director
The head of the FDA device division leaves amid scandal and the head of the drug division is under investigation.

The head of the U.S. Food and Drug Administration's device center stepped down on Tuesday, a move that follows a raft of scandals over safety recalls, concerns over the agency's device approval process and other controversial issues.

At the same time, the FDA announced that the inspector general of the Department of Health and Human Services is investigating a conflict-of-interest allegation involving Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research (CDER), the nation’s top official in charge of drug approvals at the Food and Drug Administration.

Daniel Schultz, who served at the agency's Center for Devices and Radiological Health (CDRH) for 15 years, resigned after reaching an agreement with FDA Commissioner Margaret Hamburg "that my stepping down at this time would be in the best interest of the center and the agency."

His departure follows a string of problems at the center, such as recalls of various products including those made by top device makers Medtronic Inc and Boston Scientific Corp thought to have met certain standards.

Last year, a group of CDRH staff scientists sent a letter to the House Energy and Commerce Committee complaining that they had concerns about how medical devices were approved without adequate checks for effectiveness and safety and that they had been pressured by their superiors to recommend device approvals against the scientific evidence.

FDA Associate Commissioner Jeff Shuren was picked to run the CDRH on an interim basis.

The investigation of Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, stems from an ethics complaint filed by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner.

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

Both Amphastar and Momenta, which is based in Cambridge, Mass., submitted applications seeking FDA approval of their generic versions of Lovenox heparin sold by Sanofi-Aventis SA. Amphastar applied in 2003, two years before Momenta.

Lovenox, a low-molecular-weight heparin, is a blockbuster biologic drug that brought in $3.5 billion in world-wide sales last year.

Amphastar, in letters sent to the FDA in April and June, cited some public contacts and email between Dr. Woodcock and one of Momenta's founders, Massachusetts Institute of Technology biological engineering professor Ram Sasisekharan, beginning in February 2007. Among those contacts was their attendance at an international medical conference in Thailand in November 2007.

Drs. Woodcock and Sasisekharan, along with other Momenta scientists, then co-authored two medical journal articles last year identifying the cause of the contaminated Chinese heparin imports, a finding that won scientific -- as well as Wall Street -- kudos for Momenta.

It is unusual for FDA officials to co-author journal articles with industry researchers, though the FDA said it encourages publication in journals in collaboration with noted scientists. Dr. Woodcock, who joined the FDA about 20 years ago, has done so only a handful of times in recent years. In addition, this instance occurred in the middle of a drug-approval process.

Dr. Woodcock has held her post since 1994, except for two years as deputy commissioner under George W. Bush.