The FDA's new effort to make it easier to create generics of risky drugs
- Risk Evaluation and Mitigation Strategy (REMS) is a program set up by the FDA to ensure safe use of potentially dangerous drug. Elements of the program include a communication plan, medication guides, and elements to ensure safe use of the drug (ETASU).
- As RAPS' Alec Gaffney explains, one of REMS' overarching goals is to keep drugs out of the hands of patients who won't benefit from them. However, some companies that manufacture brand-name drugs have used REMS to stifle market competition, by using ETASUs to tightly control access to the drugs. Without access, generic manufacturers cannot copycat the drugs.
- FTC regulators have not chosen to intervene. But there's legislation working its way through Congress that would require brand name companies to make products available to generic manufacturers. The legislation would also allow generics companies to request that the FDA intervene on their behalf—and now, as RAPS reports, the FDA is also moving forward with its own draft guidance that would allow companies to ask the agency to review whether certain protocols are similar to those necessary under REMS.
This past summer, BioPharma Dive reported on how the misuse of REMS was subverting competition. When the FDA initiated REMS programs in 2007, the goal was to encourage physicians and patients to use drugs safely. Attaching a REMS requirement to a drug unlikely to receive approval allows the FDA to green light treatments that come with safety concerns, yet may still benefit patients. In addition, many of the REMS programs—including education programs, access programs, and prescription dispensing restrictions—are beneficial for the industry at large.
Ralph Neas, president and CEO of the Generic Pharmaceutical Association (GPhA), explained to BioPharma Dive that subversion of REMS translated into $5.4 billion in annual losses due to generic drugs not allowed to come to market.
Four months later, change is already underway at the FDA.