Abstract
Faced with an epidemic of drug abuse and overdose deaths involving prescription opioid pain relievers, the Food and Drug Administration (FDA) plans to require opioid makers to provide training for physicians and patient-education materials on the appropriate prescribing and use of extended-release and long-acting versions of these drugs. But since July, FDA officials have been scrambling to revise their proposed Risk Evaluation and Mitigation Strategy (REMS), after an advisory panel (the agency's Anesthetic and Life Support Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee) voted 25 to 10 against the FDA's plan, saying it didn't go far enough. Advisors urged that training in appropriate use of opioids be made mandatory for all physicians who prescribe them.