The Food and Drug Administration (FDA) on May 31 issued two draft guidance documents aimed at helping get more generic drugs with safety restrictions onto the market faster, a key principle of the Trump administration’s plan to lower prices.
One new guidance outlines the process in which brand and generic drugmakers must share the risk evaluation and mitigation strategies (REMS) that the FDA places on certain drugs whose safety monitoring is mandatory. Generics are required to carry the same REMS as the brands they are mimicking — but reaching a deal on a so-called shared REMS has been a tool used by brand drug companies to delay generic equivalents.
A second guidance outlines when and how the FDA will consider waivers from required single shared REMS, and how generic drugmakers can request the waivers. The FDA will waive the requirement if the generic’s REMS is different but comparable to that for the brand if the burden for a single REMS outweighs the benefit or an aspect of the REMS is covered by a patent or trade secret.
Read statements from FDA Commissioner Scott Gottlieb, MD, here.