To include your compound in the COVID-19 Resource Center, submit it here.

Weaving new threads into FDA

FDA reorganization removes political appointees; adds industry perspective

FDA organizational changes and personnel appointments announced last week could help depoliticize the agency's decision making, increase its understanding of the way industry operates, and, possibly, improve coordination of drug, biologics and device oversight.

The reorganization, which was set in motion by the January departure of Joshua Sharfstein as principal deputy commissioner, also could deepen the bench of managerial talent at an agency that has traditionally valued technical competence over management skills.

The new structure wipes the principal deputy commissioner box off the organizational chart, eliminating a powerful White House appointment. The creation of four directorates also creates a new layer of management between the commissioner and the directors of the centers that conduct product reviews and oversight (see "FDA's Directorates").

Commissioner Margaret Hamburg's decision to break an unspoken taboo against hiring senior officials with industry experience is probably more important than the new structure. She selected Stephen Spielberg, a pediatric pharmacologist whose career includes over a decade at Johnson & Johnson and Merck & Co. Inc., to manage the centers responsible for medical products and tobacco (see "Stephen, not Steven," A10).

Another personnel decision also breaks new ground and could have an important impact on industry.

In a memo to FDA's legal staff, HHS acting chief counsel William Schultz

Read the full 2053 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE