FDA’s Top Medical Device Regulator Steps Down, Another Top Official Under Investigation

As my colleague wrote about in April, the FDA has come under fire from internal dissent over questionable medical device approval. Earlier this month on August 11, Dr. Daniel G. Shultz, the FDA’s Director of the Center for Devices and Radiological Health, announced he is resigning after 15 years on the post. The move comes after a “mutual agreement” with newly appointed FDA Commissioner Margaret Hamburg.

The controversy about Dr. Schultz came to light two years ago when Senator Chuck Grassley (R – Iowa) held hearings over Dr. Schultz’s approval of a nerve stimulation device, an approval that came over the objections of several FDA doctors. Dr. Schultz defended his decision, stating it was based solely on sound scientific data, although critics say he favored the industry over patient health.

Then again in March of this year, Senator Grassley opened an investigation over Dr. Schultz’s approval of a knee-surgery device – Menaflex – manufactured by ReGen Biologics, Inc due to reports of the Wall Street Journal. Dr. Schultz took full control of the process, and again approved a device despite vocal objections by FDA reviewers and doctors. In addition to approving the device, the approval process was even put on the fast track approval route, allowing it to reach the market quicker than normal.

These controversial decisions are not all that will define Dr. Schultz – Dr. Hamburg praised him in a statement, saying he will leave behind a “strong legacy,” but his ethical decisions are in part what has plagued the FDA in recent years. It’s good to see the new commissioner may be taking the steps necessary to preserve the integrity of the FDA.

The departure of Dr. Schultz was made around the same time that the longtime head of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock, came under investigation after a drug company accused her of having inappropriate close professional ties to a rival drug company. The Inspector General’s Office at the Department of Health and Human Services is now investigating these claims.