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Opioid policy

Recommendation 6c: To promote rapid adoption of treatments for opioid use disorder, regulatory agencies should increase their willingness to approve medications using data from trials conducted abroad rather than re-inventing the wheel. 

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     In developed countries collectively, the range of medications used to treat OUD is broad, including oral methadone, injectable methadone, oral buprenorphine, injectable extended release buprenorphine, implanted buprenorphine, slow release oral morphine, injectable hydromorphone, injectable diacetylmorphine, inhaled/smoked diacetylmorphine, injectable extended release naltrexone, and naltrexone implants. Yet in any given country, only a subset of these medications is approved and available, reducing opportunities to expand the appeal of treatment options to a broader population and to tailor treatment to individual needs.

     Regulatory agencies (e.g., the U.S. FDA) often consider international evidence to a limited extent, but still require extensive in-country data collection before drug approval, including new safety and dosage studies for drugs that have been used for many years in other developed countries. Given the exigency of the opioid epidemic, relaxing these requirements legislatively and administratively could bring more medications to patients with OUD more quickly.