Markey Looks for Answers on FDA’s Opioid Approval Process

Citing a national opioid crisis and the frequency of deaths associated with OxyContin overdoses, a lawmaker is asking FDA Commissioner Robert Califf about how the agency administers Risk Evaluation and Mitigation Strategies for prescription opioids.

Sen. Edward Markey (D-Mass.) is calling for the FDA to require REMS for immediate-release opioids in addition to those already required for extended-release and long-acting opioids.

The senator also slammed the agency for approving Purdue Pharma’s OxyContin despite an advisory committee finding that its product-specific REMS were not sufficient.