New policies that aim to help generic drug makers move their products through the development and approval processes more efficiently have been announced by FDA Commissioner Scott Gottlieb, MD.
New policies that aim to help generic drug makers move their products through the development and approval processes more efficiently have been announced by FDA Commissioner Scott Gottlieb, MD. The policies also aim to maintain safety controls sought by the Risk Evaluation and Mitigation Strategy (REMS) requirements.
“The first draft guidance being issued today, Development of a Shared System REMS, describes general principles and recommendations to assist sponsors with developing these programs. The goal is to improve the clarity and efficiency for developing shared system REMS, which will enable timelier market entry for products that are part of these REMS,” Gottlieb said in a statement. “The second draft guidance, Waivers of the Single, Shared System REMS Requirement, describes when and how the FDA will consider waiving the single, shared system requirement, and how generic applicants can request a waiver.”
According to Gottlieb, the FDA may waive the single, shared system REMS requirement, and permit the generic company to use a “different, comparable” aspect of the Elements To Assure Safe Use law if the agency finds that the burden of forming a single shared system outweighs the benefits of having one, or an aspect of the REMS is covered by a patent or is a trade secret and the generic applicant certifies that it sought a license for use of that aspect and was unable to obtain one. This draft guidance describes the factors the FDA will consider in evaluating a request for a waiver of the single, shared system REMS requirement, Gottlieb said in his statement. The guidance makes clear that while the FDA encourages companies to work together to form a single, shared system, the agency will consider a waiver at any time. The draft guidance also provides recommendations to generic drug applicants regarding the submission, and content of waiver requests.
“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,” said Gottlieb in a statement. “We’re also going to be clearer about the circumstances when we’ll issue waivers to let the generic firms develop their own REMS program. Our safety programs shouldn’t be leveraged as a way to forestall generic entry after lawful IP has lapsed on a brand drug. Our market-based system for rewarding innovation is dependent on this kind of legal competition.”
The Association for Accessible Medicines (AMA) applauded the FDA for addressing the issues that have affected generic and biosimilar drug competition, as well as price reductions for patients, in a statement. “Calls for voluntary action by brand companies to stop their efforts to thwart generic competition are not enough. It is time for Congress to pass the CREATES Act which will help put an end to these types of abuses and free up the generic and biosimilar competition the President is prioritizing in his American Patients First platform,” said Chip Davis, president and CEO of the AMA, in the statement.