The Obama administration is going outside the FDA for its new leaders. Obama has settled on former New York health commissioner Margaret A. Hamburg (photo) as the new head of the FDA, sources tell the Washington Post. And in a selection likely to alarm many in the biopharma industry, Joshua Sharfstein (photo) will serve as deputy commissioner. Sharfstein--the Baltimore health commissioner--tackled the drug industry head on in 2007 when he petitioned the agency to restrict cold meds for children.
The selection was a clear mandate for change at the FDA, which has been harshly criticized in recent years for being too close to the drug industry and not concerned enough with patient safety. At the same time, developers have raised a hue and cry of their own, saying that the agency has leaned over too far backwards to compensate, raising the cost of development as it raises the bar on the data it requires for an approval.
Both sides of the debate often concur, though, that the FDA is dysfunctional. Now Hamburg, who faces a Congressional hearing, and Sharfstein will be put to the test to see if they can satisfy an industry hungry for clarity on new approvals and consumer advocates who insist on a more prudent review process.
- read the report from the Washington Post