Regulatory Focus™ > News Articles > FDA Enacts New Class-wide REMS Policies for Opioids

FDA Enacts New Class-wide REMS Policies for Opioids

Posted 09 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) announced 9 July the approval of a new Risk Evaluation and Mitigation Strategy (REMS) for the most potent opioid products on the market, saying in a statement that the new policies are meant to balance patient access and safety measures to improve the safe use of the products.

The new REMS policy will cover all extended-release (ER) and long-acting (LA) opioid products, and will rely primarily on educational products, which the more than 20 sponsors of ER and LA opioid products will need to make available to prescribing entities. Prescribers will be trained using materials FDA estimates will be available by 1 March 2013.

In a statement, FDA said the materials will "include information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients and counseling patients on the safe use of the these drugs." Additional information will cover the drugs' potential for abuse by patients, and how best to respond to misuse, abuse and addiction.

While much of the policy focuses on prescribers, patients will also receive FDA-approved educational materials regarding how to use opioids safely and opioid-specific counseling from physicians.

"Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge," said FDA Commissioner Margaret Hamburg. "The FDA's goal with this REMS approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs."

The Future of REMS?

FDA said in a statement the companies will be required to conduct "periodic assessments" of the programs to ensure they are meeting the program's goals, and FDA will conduct reviews of the assessments and reserves the right to "require additional elements to achieve the goals of the program."

The move has long been anticipated by industry after FDA noted in December 2011 that it would be formulating a class-wide REMS program for all opioid products. The move was announced in a 29 December 2011 news release approving a shared REMS system for transmucosal immediate-release fentanyl (TIRF) products, which was seen as perhaps providing the model for later shared-REMS classes. As with the July 2012 announcement, FDA's December 2011 TIRF REMS focused on "educating prescribers, pharmacists and patients on the potential for misuse, abuse, addition and overdose."

With the release of a class-wide REMS policy, FDA might choose to implement further REMS policies in the future based on the likelihood of abuse, particularly if it knows it can take a result-based approach and require additional elements to ensure compliance.


Read more:

FDA - FDA introduces new safety measures for extended-release and long-acting opioid medications

Regulatory Focus - FDA Releases Shared REMS for TIRF Products, Working on Shared REMS for Other Opioids


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