“We believe that by making the process for developing a shared system REMS more efficient, we’ll discourage brand drug makers from using REMS as a way to block generic entry and help end some of the tactics that can delay access,” Dr. Gottlieb said. “Our safety programs shouldn’t be leveraged as a way to forestall generic entry after lawful IP has lapsed on a brand drug.”
“Today’s FDA guidance is a step in the right direction toward our common goal of lowering out-of-control drug prices,” the Campaign for Sustainable Rx Pricing said in a statement “When generic and biosimilar competition is thwarted by these abusive tactics, brand-name manufacturers, who alone control the price of their drugs, keep those prices artificially high. The problem is the price, and more competition is a proven solution.”
Comments on each of the draft guidance documents are due July 31 at www.regulations.gov.
