BioCentury
ARTICLE | Politics, Policy & Law

Opioids clouding Califf's tenure

How Califf backlash will color PDUFA negotiations, influence FDA opioid reviews

February 1, 2016 8:00 AM UTC

The backlash against confirming Robert Califf as FDA commissioner will color ongoing user fee negotiations, influence FDA's reviews of pending applications for opioid drugs, and intensify pressures on the agency to respond to political pressures on issues such as the regulation of tobacco and genetically engineered foods.

There is still a good chance that Califf will be confirmed. If and when he moves into the top slot from his current position as deputy commissioner for medical products and tobacco, Califf will be under intense pressure to demonstrate independence from regulated industry, as well as sensitivity to politically charged issues such as drug pricing and opioid addiction. ...