FDA Updates Guidelines to Prevent Companies From Blocking Generic Drug Competition

Pharmacy TimesAugust 2018 Pain Awareness
Volume 84
Issue 8

The FDA is stepping in to prevent pharmaceutical companies from controlling drug distribution and, as a result, limiting the market entry of generics. New regulation changes will address this issue, encouraging competition and boosting accessibility.

Although FDA officials support market-based rewards for innovation in pharmaceuticals, it also promotes access to effective and safe generic equivalents when a medicine’s patent expires. However, some drug manufacturers have strategies to keep generics from the market, resulting in a lack of competition, according to a statement from the FDA.

For example, the FDA requires a company to develop a Risk Evaluation and Mitigation Strategy (REMS) program to ensure the safe use of drugs that have a high risk of adverse effects, and brand drug makers might take advantage of REMS to prolong the entry process of generic equivalents, according to the statement. Companies can manipulate REMS during drug development by limiting access to a product and prolonging the equivalency testing process. They also can exploit REMS at the end of the process, when testing is completed and FDA approval of a generic version is sought. The FDA’s new policies will address the latter form of entry blockage from brand drug makers, according to the statement.

The issue arises from the requirement that brand and generic drug makers share a REMS program if approval is sought for a generic equivalent of a brand drug with an existing program. This requirement applies to all generic drug applicants, unless the FDA waives it and allows a generic drug maker to produce its own REMS program.

Although a shared REMS program can be convenient for health care providers, it can delay the approval process for the generic drug applicant, according to the FDA. Both companies must nego- tiate on a shared program before the generic drug can be approved, which can significantly extend the approval process and delay entry for generic drugs.

The new FDA policies address REMS’ role as a tool for ensuring safety rather than complicating market entry for generic drugs, according to the statement. The first draft of guidelines and recommendations to assist drug manufacturers in developing shared REMS programs has been released in an effort to improve timeliness in approval and market entry of generic drugs.

The second draft, Waivers of the Single, Shared System REMS Requirement, is geared toward informing generic drug makers on the FDA’s considerations and application process for waiving the requirement. The FDA will consider a waiver if the burden of coming to an agreement with a brand drug maker outweighs the benefit of generic entry.

A waiver will also be considered if part of the REMS is patented or kept secret by the brand-drug maker, and the generic drug maker has unsuccessfully attempted to obtain the information through licensure, according to the statement.

FDA officials said they believe that the new guidelines for negotiation shared REMS programs will discourage misuse by brand drug makers to enter the market more easily


Statement from FDA Commissioner Scott Gottlieb, MD, on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access [news release]. Silver Spring, MD: US Food and Drug Administration; May 31, 2018. fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm609365.htm. Accessed June 29, 2018.

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