Letter asks for more information on Risk Evaluation and Mitigations Strategies, or REMS, process in light of prescription opioid crisis

Washington (April 21, 2016) – Senator Edward J. Markey (D-Mass.) today sent a letter to the Food and Drug Administration (FDA) inquiring about its process for ensuring that the public is protected from the risks of abuse, misuse, addiction and overdose deaths associated with prescription opioid use. The Risk Evaluation and Mitigations Strategies (REMS) are a series of specific actions required by the FDA of a drug manufacturer that is intended to lessen the risks of the drug being sold. REMS actions can include actions such as the creation of patient registries or communications with health providers outlining safety concerns. In some cases, absent a REMS, the FDA might not have approved a drug for sale because without it, the drug’s risks would have outweighed its benefits.Experts have questioned the effectiveness of REMS and FDA’s consistent evaluation of whether the process works as intended to mitigate risk associated with certain drugs. The FDA first required a product-specific REMS for OxyContin in 2010. Then, in 2012, the FDA approved a post-market shared REMS for a group of highly potent prescription opioid painkillers know as extended-release and long-acting formulations. However, 90 percent of all prescription opioids are immediate release formulations and are currently not subject to REMS.

“FDA’s review of these REMS is especially important given the ongoing public health crisis arising from the abuse, misuse, addiction and overdose deaths associated with opioids, and the frequency with which OxyContin is implication, despite having a REMS in place since 2010,” writes Senator Markey in the letter to FDA Commissioner Robert Califf. “The FDA cannot ensure that the public is protected from the known risks of opioids if it is not consistently requiring REMS for every opioid and if it is not effectively monitoring their performance and responding if they are inadequate.”

A copy of Senator Markey’s letter to the FDA can be found HERE.

In his letter, Senator Markey asks questions that include what assessment has the FDA completed of the success of the drug-specific REMS for OxyContin, if the FDA has ever taken an enforcement against an opioid manufacturer subject to REMS, if the FDA plans to make REMS data more transparent and publicly available, and if the FDA anticipates any policy changes regarding the use of REMS for abuse-deterrent formulations.