The U.S. Food and Drug Administration (“FDA”) recently announced a “far-reaching action plan” to evaluate and improve the agency’s prescription opioid policies. The announcement came amidst public criticism and mounting political pressure on the FDA to address the country’s “opioid abuse epidemic,” including a hold placed by Senate Democrat Edward J. Markey on President Obama’s nominee to lead the FDA, Dr. Robert M. Califf. In a December 21, 2015 letter to U.S. Department of Health & Human Services (“HHS”) Secretary Sylvia M. Burwell, Senator Markey warned that he would block a vote on Califf’s nomination to be FDA commissioner until the FDA commits to rescinding pediatric OxyContin approval, empaneling advisory committees on any future opioid-approval questions, and immediately ensuring that issues of addiction, abuse, and dependence are considered by the FDA when making a final decision about the approval or indication(s) for an opioid drug.
The FDA’s plan provides agency responses to eight issues relating to opioid abuse:
The primary objective of the FDA’s multi-prong plan is largely information gathering. This likely will mean more extensive post-marketing testing and reporting requirements for pharmaceutical manufacturers, including additional studies and analyses of the health risks and benefits associated with long-term use of ER/LA opioids previously approved for sale by the FDA and opioid alternatives. Providers, meanwhile, may be subject to new CDC and Surgeon General guidelines for opioid prescribing for chronic pain outside of end of life care. Additional, more immediate changes may ensue, as the FDA’s plan came under criticism within hours of its unveiling last week. Senator Markey, for example, complained that the above proposals “fall short of what is needed” and indicated that he would continue to block Dr. Califf’s candidacy until the FDA commits to holding advisory committees of outside experts for all opioid approval decisions.
How the FDA proceeds remains to be seen. Foley will closely monitor and report on any proposed agency action.