Pharmacy News Article

Washington Roundup

In the latest salvo against the growing problem of prescription drug abuse and misuse, the FDA approved a classwide risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioid drugs.

A key part of the REMS, which will impact more than 20 drugmakers and 30 brand and generic products such as OxyContin, is a requirement to provide continuing education for prescribers of the drugs.

The agency has developed a content blueprint for the training and will audit the programs to ensure they follow that plan, FDA Commissioner Margaret Hamburg said during a media call Monday.

The agency expects sponsors will award educational grants to accredited continuing education providers so they can offer the training to prescribers at no or nominal cost. The first courses, which will test prescribers on what they have learned, are to be offered by March 1.

The training program will be voluntary for prescribers, at least for now.

The FDA is working with Congress to make the training a mandated part of a prescriber's registration with the Drug Enforcement Administration, Hamburg said.

The REMS also will require drugmakers to distribute educational materials to prescribers and patients on the safe use of the powerful pain medications.

The REMS has been in the works for more than three years. In February 2009, the agency first informed manufacturers of certain products containing buprenorphine, fentanyl, hydromorphone, methadone, morphine, oxycodone and oxymorphone that their drugs would be required to have a REMS, citing an increase over the past decade in the misuse, abuse and accidental overdose of opioids. (See BioWorld Today, Feb. 17, 2009, and April 21, 2011.)

Obama Signs PDUFA

With little fanfare, the president signed the FDA Safety and Innovation Act Monday, reauthorizing PDUFA and creating new user fees for generic drugs and biosimilars. The law will go into effect Oct. 1, setting the user fees for the next five years, making two pediatric programs permanent and offering incentives for new antibiotics. The House and Senate passed the bipartisan bill last month. (See BioWorld Today, June 21, 2012, June 27, 2012, and July 6, 2012.)