FDA Panels Vote Against Plan to Reduce Opioid Abuse

Key issue cited by an FDA official was lack of mandatory training for prescribing doctors
By Beth Gilbert
HealthDay Reporter

MONDAY, July 26 (HealthDay News) -- On July 23, two U.S. Food and Drug Administration advisory panels voted against the FDA's plan for reducing abuse of long-acting and extended-release opioid drugs.

In February, the FDA issued a Risk Evaluation and Mitigation Strategy (REMS) for all extended-release and long-acting opioid drugs in an attempt to rein in the growing misuse and abuse of the drugs by educating physicians and patients about associated risks. Extended-release and long-acting opioids pose an increased risk of serious adverse events compared with shorter-acting formulations due to their formulations and chemical properties.

However, during the joint meeting of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees, committee members voted 25 to 10 against the FDA's proposal. John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said at a news conference that the members who voted no believe a REMS is needed but that the FDA's proposal did not go far enough. Specifically, he said those who voted no wanted the training for prescribing physicians to be mandatory, not voluntary. He noted that the magnitude of such a training program would be extremely large.

"There are concerns about the burden that would place on the health care system. Because of the size of the program, there were concerns that some prescribers might choose to opt out of the program, and that might impact on patients' access to care for relief of their pain," Jenkins added.

More Information

Copyright © 2010 HealthDay. All rights reserved.

Powered by

jQuery UI Accordion - Default functionality

For life-long learning and continuing professional development, come to Lippincott's NursingCenter.

Nursing Jobs Plus
Featured Jobs
Recommended CE Articles

Blunt Chest Trauma
Journal of Trauma Nursing, November/December 2014
Expires: 12/31/2016 CE:2 $21.95

The School Age Child with Congenital Heart Disease
MCN, The American Journal of Maternal/Child Nursing, January/February 2015
Expires: 2/28/2017 CE:2.5 $24.95

Understanding multiple myeloma
Nursing Made Incredibly Easy!, January/February 2015
Expires: 2/28/2017 CE:2 $21.95

More CE Articles

Subscribe to Recommended CE

Recommended Nursing Articles

Comprehensive Care: Looking Beyond the Presenting Problem
Journal of Christian Nursing, January/March 2015
Free access will expire on March 2, 2015.

Pain and Alzheimer dementia: A largely unrecognized problem
Nursing Made Incredibly Easy!, January/February 2015
Free access will expire on February 16, 2015.

Glycemic control in hospitalized patients
Nursing2015 Critical Care, January 2015
Free access will expire on February 16, 2015.

More Recommended Articles

Subscribe to Recommended Articles

Evidence Based Practice Skin Care Network NursingCenter Quick Links What’s Trending Events