FDA May Reconsider Policy on Opioid Black Boxes

September 1, 2015

The FDA may be reconsidering its policy of only requiring black box warnings on extended-release opioids, telling lawmakers that a citizen petition to require the same warnings for immediate-release opioids is under “active consideration.”

The Aug. 12 letter, released last week, responds to concerns of bipartisan leaders of the House Energy & Commerce Committee about the agency’s 2013 policy exempting IR opioids from black box warnings and the effectiveness of risk evaluation and mitigation strategies for extended-release versions of the potent painkillers.

On the issue of black box warnings, the FDA suggests new information may warrant rethinking of its policy exempting IR opioids. The agency points to data in a 2014 petition filed by Purdue that shows comparable risks for misuse and abuse with both IR and ER formulations.

Regarding REMS, the FDA says metrics, data sources and methodologies for assessing those strategies is evolving, and notes the 2015 REMS assessment — the first to include prescriber knowledge surveys and evaluate of whether specific milestones for prescriber training had been met — is under review.

On the plus side, a 2014 REMS assessment report showed a statistically significant reduction in the number of prescriptions for both ER and IR opioids, as well as decreases in abuse, misuse, hospitalizations and deaths, the FDA says. However, those changes were not solely due to REMS, as many efforts are ongoing to raise awareness.

In response to another question, the FDA explains that it removed mandatory prescriber training and patient registries from its initial design of REMS because the requirements would have been unduly burdensome for drugmakers, physicians and pharmacists. The agency continues to support mandatory education for prescribers as a component of risk management for all opioids, as called for in the 2011 Prescription Drug Abuse Prevention Plan.

Committee Chairman Rep. Fred Upton (R-Mich.), ranking member Frank Pallone (D-N.J.), Oversight and Investigations Subcommittee Chairman Tim Murphy (R-Pa.) and ranking member Diana DeGette (D-Colo.) requested the information from the FDA.

Read the FDA’s response here: www.fdanews.com/8-15-Opioid-Letter.pdf. — Jonathon Shacat