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FDA Seeks Expert Feedback on REMS for Fentanyl Products

August 3, 2018

FDA Commissioner Scott Gottlieb outlined what the agency hopes to learn from an advisory committee Friday at a meeting about safety measures for transmucosal immediate-release fentanyl (TIRF) products.

The expert group will consider the agency’s REMS with elements to assure safe use of the products. The TIRF REMS were approved in December 2011 to ensure only appropriate patients are prescribed the drugs. It includes provisions designed to limit its use only to opioid-tolerant patients to lessen accidental exposure and describe its potential for misuse, abuse, addiction and overdose to patients, doctors and pharmacists.

Gottlieb said the program appears to be operating as intended (to make sure prescribers and pharmacists are instructed on the meds’ risks and safe uses), but he cautioned there may be more to be done as “a REMS can achieve functional compliance‚Ķbut not fully achieve its intended public health purpose.”

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