FDA releases new policies on REMS programs used to block generic competition and access

In a May 31 statement, US Food and Drug Administration Commissioner Scott Gottlieb said the agency was reforming its regulations around the Risk Evaluation and Mitigation Strategy (REMS), a method for pharmaceutical companies to control the distribution of drugs that have serious risks and balance drug benefits with hazards.

That system enables market-based rewards for novel innovation as a way to create incentives for the time, risk and capital required to develop new medical advances. At the same time, the law allows for brisk competition from safe and effective generic medicines once the period of patent protection or exclusivity has lapsed on a new medicine.

“But we know that there are situations where that expected competition isn’t materializing in a timely manner. Sometimes this is the result of tactics that brand drug makers adopt,” said Dr Gottlieb.