Last week, the Senate confirmed Robert Califf to run the FDA by a narrow vote of 50-46. Califf had previously served as the FDA Commissioner in the final months of Obama’s presidency before Janet Woodcock took over as interim chief. After a 13-month holding pattern, placing Califf as a permanent leader will hopefully bring some stability to the agency. A recent POLITICO article (well worth reading the full article) discussed 6 challenges that await Califf as he takes the reins. The include:
- Emergency Use Authorization
- User Fees
- Accelerated Approval Pathways
- Tobacco Regulation
- Opioids
- Abortion Pills