- Two lawmakers have reintroduced the Fair Access for Safe and Timely Generics Act, which explicitly addresses Risk Evaluation and Mitigation Strategies (REMS) abuse, according to the WSJ's Ed Silverman.
- The bill, which was introduced by Reps. Steve Stivers (R-OH) and Peter Welch (D-VT), was also brought up last year, but failed.
- Generic drug makers have claimed that their ability to copycat brand name drugs is often compromised by brand name drug manufacturers that deny them access to samples needed to conduct product testing.
When BioPharma Dive first covered this issue in December 2014, the conversation around this topic was just starting to gain momentum. Risk Evaluation and Mitigation Strategy (REMS) is a program set up by the FDA to ensure safe use of potentially dangerous drugs—but the goal of this program has been subverted.
According to a 2014 study from the Generic Pharmaceutical Association (GPhA), REMS abuse costs the U.S. healthcare system $5.4 billion per year in pharmaceutical spending. However, Stivers and Welch aim to address the problem of REMS abuse with a bill that positions the Department of Health and Human Services (DHHS) as the intermediary between the generic and the brand manufacturers. Under the proposed scenario, generics companies would seek authorization from the DHHS and then submit a request to a brand manufacturer, along with the authorization.
In a statement issued by the GPhA on June 18, Ralph Neas, President and CEO of GPhA, said, "The FAST Generics Act sets forth more explicit legal requirements and processes for the acquisition of product samples by generic and biosimilar developers, at the same time putting safeguards in place to protect public health."
A previous iteration of the same bill failed last fall; however, since then, the issue has been gaining momentum. There is also a greater awareness on the part of generics manufacturers that responding to REMS abuse agressively is not inappropriate—and that may help advance the bill.