FDA will stay course post-Sharfstein

Don't expect a relaxation of the FDA's crackdown on sloppy manufacturing in the wake of Joshua Sharfstein's departure. The Deputy Commissioner is often credited with setting the agency agenda following his review of approval processes for medical devices and drugs.

Although frequently cited as the driver of FDA's stepped-up enforcement of manufacturing, safety and marketing regulations, the Obama appointee is the left lead in a one-two punch that includes like-minded Commissioner Margaret Hamburg. She told Reuters last November that she's not going anywhere.

Sharfstein was never a behind-the-scenes number 2. Congress certainly got to know him during his two-year tenure, particularly at hearings last fall on the Johnson & Johnson Tylenol recalls that also probed the FDA's relationship with the healthcare products giant.

He's also credited as a driver in the regulator's efforts to be more forthcoming to the public about its decision-making.

- see the article
- here's more