FDA Fires Back at Study Critiquing Opioid REMS Strategy

The FDA is taking issue with a new study that says the agency can’t tell if its risk evaluation and mitigation strategy (REMS) program for extended-release and long-acting opioids is effective.

In an article in the journal JAMA Internal Medicine, researchers at the Johns Hopkins Bloomberg School of Public Health concluded that the FDA couldn’t determine if the REMS program has been successful. The article was based on an analysis of more than 9,700 REMS-related documents from inside the agency.

In a three-page response emailed to FDAnews, the FDA defended the REMS program, saying the study’s authors “erroneously state that FDA abandoned efforts to evaluate the impact of the ER/long-acting REMS program on prescriber behavior and patient outcomes.”