FDA and SAMHSA Issue Joint Statement in Support of Reducing Barriers to Evidence Based Treatments

On May 9, 2023, the U.S. Food and Drug Administration (FDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a joint statement regarding both agencies’ commitment to providing evidence-based treatments for opioid use disorder (OUD).

In the letter, the agencies summarize their commitment to increasing access to safe and effective medication for OUD through highlighting some recent changes in the field including the removal of the DATA Waiver (also known as the X-waiver) registration requirement. As explained in a previous blog, this change allows providers to dispense certain medications that are controlled substances without a separate registration process as previously required.

The agencies clarified that while counseling services play an incredibly important role in treatment, they do not believe that problems accessing behavioral health resources or counseling should prevent a prescriber from prescribing medication to patients when necessary. The agencies acknowledge that when other resources are not available, medication alone, such as buprenorphine, can still benefit the patient and should be accessible.

Finally, the letter explained that every patient’s treatment plan should be person-centered and may differ based on each person’s place in the recovery process. The agencies emphasized that they are committed to addressing the overdose epidemic through a combination of person-centered care and reducing barriers to evidence based treatments.

While this letter does not disclose any changes in laws or regulations related to OUD, this letter is notable as a policy statement highlighting the agencies’ stance on intended flexibilities associated with the opioid epidemic and increasing access to safe and effective medicines. Additionally, the letter is of interest insofar as it was jointly issued by both agencies.

Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group with any questions.

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