FDA Gives Update on Actions to Address Opioid Crisis

On Oct. 24, 2019, FDA Acting Commissioner Ned Sharpless, MD issued a statement regarding the progress the agency has made in combating the opioid crisis in the United States. The agency’s implementation of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), which was passed in October 2018, has included guidance documents, prescribing guidelines, drug tracking and protection, and packaging recommendations.

One of the first steps in implementing the SUPPORT Act was the assessment of the use of non-opioid drugs to treat pain that would otherwise be treated by opioids. The agency held an advisory committee meeting and issued draft guidance on the issue that describes the benefit-risk assessment framework FDA uses to evaluate applications for opioid drugs. In addition, input was requested by FDA on potential new preapproval incentives for the development of new pain treatments.

To strengthen and protect the US market, FDA and the US Customs and Border Protection (CBP) worked with the US Postal Service to present Congress with enhancements to improve screening of packages coming into the US from international mail facilities. A Letter of Intent was signed by FDA and CBP to establish strategies for collaboration between the agencies to develop procedures for information and operation sharing. The agencies plan to establish a list of controlled substances imported into the US. Since October 2018, FDA identified 9800 drugs processed through international mailing facilities that contained ingredients determined to be a health concern. Most of these, according to FDA, were refused entry.

The agency has also proposed packaging opioids in fixed-quantity, unit-of-use blister packaging, possibly reducing the number of unused opioids that could be abused. FDA opened the suggestion to public comment and is evaluating the responses.

Additional actions included guidance on postmarketing studies and clinical trials “to assess the potential reduction in effectiveness of a drug and how such reduction in effectiveness could result in a change to the benefits of the drug and the risks to the patient.” The agency is also working on a report for Congress on access barriers to abuse-deterrent opioid formulations under Medicare. Ongoing efforts also include guidance documents on the development of non-opioid pain treatments.

“While we are proud of these accomplishments, we know that there is still more to do. We will continue to implement the SUPPORT Act to build upon our efforts and adapt our responses to confront the changing nature of the opioid crisis. The FDA remains committed to addressing this national crisis on all fronts, with a continued focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies; and taking action against those who contribute to the illegal importation and sale of opioid products. The agency will continue to use its regulatory authority to address this crisis, and the additional tools that the SUPPORT Act provides are helping us accomplish this vital work,” said Sharpless in the statement.

Source: FDA