FDA chief proposes new rules for providers, pharma to curb opioid addiction: 5 things to know

The Food and Drug Administration is poised to take further regulatory action to combat the nation's opioid crisis, according to a Bloomberg report.

During a public FDA meeting in Silver Springs, Md., Commissioner Scott Gottlieb, MD, discussed plans for new regulations to address the proliferation of immediate-release opioids in the U.S.

Here are five things to know about the FDA's plans to increase opioid regulations.

1. Immediate-release opioids account for 90 percent of the nation's 200 million opioid prescriptions written every year.

2. The FDA plans to require drugmakers to provide physician education programs for clinicians prescribing immediate-release opioids. The agency already requires comparable education programs for extended-release opioids.

3. The regulatory agency is also considering whether pain-management training should be required for physicians, nurses, pharmacists and other healthcare providers.

4. Dr. Gottlieb also said the FDA plans to survey physicians to ensure the term "abuse-deterrent" does not promote a false sense of safety regarding the likelihood of patients developing opioid addiction simply because the medications are more difficult to crush.

"We don't want to improperly convey a perception that a product that's resistant to manipulation and abuse is somehow also less prone to fueling addiction when that's simply not true," Dr. Gottlieb said, according to Bloomberg.

5. The new plans would build on previous actions taken by the FDA under Dr. Gottlieb to address the nation's opioid epidemic. In June, the agency issued a withdrawal request to Endo International to remove its opioid painkiller Opana ER from the market. The move marked the first time the FDA issued such a request for an opioid due to public health concerns. On July 6, Endo announced it would voluntarily recall the product.

More articles on opioids: 
Metro Health – University of Michigan Health to distribute free Narcan kits: 3 things to know 
Maryland governor allocates $22M to fight state opioid epidemic 
NQF launch effort to improve opioid stewardship

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars