Establish guidelines for post-market surveillance of controlled substances

A controlled substance is a medically prescribed drug or substance regulated by the government because of its propensity for misuse and addiction.[2] Since all potential side effects of a drug can't be identified during the pre-approval phase, the Food and Drug Administration (FDA) maintains a system of post-marketing surveillance or requiring drug companies to conduct additional studies once a drug has already been approved for marketing.[3] Information the agency obtains from this process is used to update the drug’s label or revisit the approval decision.[3]

Historically, phase three clinical studies of opioid analgesics have examined the drug over a 12-week treatment period, with long-term safety extensions of 6 to 12 months. Accordingly, there are limited controlled study data evaluating the effectiveness of opioids beyond 12 weeks. Due to the paucity of pertinent high-quality data and safety concerns there is a need for more clinical trial data to better inform the benefit-risk balance of long-term opioid use. In April 2023, the FDA held a meeting of its Anesthetic and Analgesic Drug Products Advisory Committee to examine how clinical trials could be designed and executed to fill the knowledge gaps about long-term usage of opioids.[4] The FDA should move forward expeditiously with this work and apply such frameworks to other controlled substances as well.