Establish guidelines for post-market surveillance of controlled substances

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The Food and Drug Administration (FDA) should establish guidelines for post-market surveillance related to diversion, addiction, and other adverse consequences of controlled substances, especially extended release and long-acting opioids.[1]


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.


1. The Kennedy Forum. The President’s Commission On Combating Drug Addiction and the Opioid Crisis. Last Updated October 2017.

2. U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Controlled Substance. Last Accessed July 27, 2023.

3. U.S. Food and Drug Administration. Post Market Surveillance Programs. Last Updated April 2, 2020.

4. U.S. Food and Drug Administration. Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee. Last Updated April 19, 2023.