Is The Opioid REMS Too Big To Study?

06 Jan 2021

• By Michael McCaughan

US FDA’s workshop to discuss new ideas to assess the impact of the opioid REMS comes after the industry collaboration behind the REMS has deemed the task essentially impossible.

The opioid analgesic Risk Evaluation & Mitigation Strategy is by far the largest effort to use the regulatory tools granted to the US FDA in the 2007 drug safety law (FDAAA) – and the uncomfortable truth is that there is still no evidence that it has had a measurable impact.

In fact, there is still no agreement on how its impact could even be measured.