FDA external report recommends actions to address US opioid crisis

The US Food and Drug Administration (FDA) has published a new external report recommending three actions the agency should take to address the US drug overdose and substance use disorder  crisis, primarily relating to opioids.

More than 107,000 Americans died from a drug overdose in 2021, according to the US Centers for Disease Control and Prevention, of which over 70,000 were as a result of using synthetic opioids containing fentanyl.

The External Review of FDA Regulation of Opioid Analgesics Final Report analysed the FDA’s implementation of the 2017 National Academies for Sciences, Engineering, and Medicine’s (NASEM) recommendations – a project also related to opioid prescribing issues – along with key regulatory policies and decisions.

Opioids are commonly used for the treatment of pain and include medicines such as morphine, fentanyl and tramadol. However, due to their pharmacological effects, the drugs can cause breathing difficulties and opioid overdose can lead to death.

The number of overdoses has increased in recent years, causing the US Department of Health and Human Services to renew its previously declared public health emergency in December 2022.

“As an agency focused on protecting public health, combatting this evolving emergency is an issue of particular urgency for us,” said FDA commissioner of food and drugs, Robert Califf, in a written statement.

The new report recommends the FDA continue its efforts to implement the recommendations in the NASEM report, including evaluating study designs to inform an approach for regulatory decision-making that incorporates public health considerations.

It is also recommended that the agency considers seeking certain additional government authorities regarding opioid approvals and review of the advertising and promotion for such products.

The third recommendation advises the FDA be ‘as transparent as possible’ regarding decision-making for opioids in order to encourage appropriate use, promote innovation in pain management and enhance public trust.

Responding to the points made in the report, Califf said: "We have reviewed these recommendations and while we are thoughtfully considering our actions to implement them, I am encouraged that the agency is already moving forward on multiple work streams, while also adapting to the changing epidemiology of the ongoing public health emergency.

“I look forward to continuing to work across the agency to advance solutions that encourage appropriate prescribing, promote innovation in pain management, prioritise overdose prevention, reduce opioid and other substance use disorders, and champion effective treatment and support for those with substance use disorder.”