ARTICLE | Regulation

REMS: Fixing Unintended Consequences

REMS: FDA being pressed to fix unintended consequences of drug risk program

August 9, 2010 7:00 AM UTC

FDA is being pressed to go back to the drawing board when it comes to designing and implementing REMS. After four days of meetings on the topic, physicians, pharmacists and the drug industry seem to agree on one thing: the agency needs to do more work to standardize the process to reduce the burden on the healthcare system and remove roadblocks to treatment.

In a two-day meeting late last month, a joint panel of the Anesthetic and Life Support Drugs Advisory Committee and Drug Safety and Risk Management Committee voted 25-10 against FDA's first proposed classwide REMS, which would cover extended-release and long-acting opioids. Panelists asked FDA to develop a stricter program than the one proposed...