Jill Wechsler

The opioid REMS project reflects FDA's interest in building on the host of provisions in FDAAA designed to ensure drug safety through the entire product life cycle. In addition to the REMS program, the statute gives the agency the power to require postapproval label changes when new safety issues arise and to crack down on manufacturers that fail to conduct agreed-on postmarketing studies. FDAAA also requires companies to list extensive clinical trial information and study results on the ClinicalTrials.gov public website. The listing is another way to ensure that safety issues that arise during clinical research are fully disclosed to regulatory authorities and to the public.

Implementing the FDAAA REMS program has been complex and time-consuming because it has required FDA to assess and update existing risk-management programs for dozens of drugs, while also developing new policies to fit its enhanced authorities. In March 2008, FDA identified some 24 manufacturers with marketed drugs such as isotretinoin, thalidomide, mifepristone, alosetron, and clozapine, that already had risk-management plans in place and thus were deemed to have REMS.