Regulatory Focus™ > News Articles > 5 > REMS Draft Guidance: FDA Looks to Deal With Exploited Requirements

REMS Draft Guidance: FDA Looks to Deal With Exploited Requirements

Posted 31 May 2018 | By Zachary Brennan 

REMS Draft Guidance: FDA Looks to Deal With Exploited Requirements

With the knowledge that pharmaceutical sponsors can use Risk Evaluation and Mitigation Strategy (REMS) requirements to block generic drugs from making a timely entry to market, the US Food and Drug Administration (FDA) on Thursday released two new draft guidance documents on developing a shared system REMS, and waivers associated with the single, shared system REMS requirement.

The exploitation of REMS requirements was front in center in FDA Commissioner Scott Gottlieb’s comments Thursday. He explained how on both the front and back end, REMS can be abused.

“On the front end, brand drug makers sometimes use REMS as a way to restrict the sale of their drugs, keeping the drug out of the hands of generic firms,” he said. But the guidance seeks to deal with the other obstacle on the back end, or “after a generic drug seeks FDA approval and market entry.”

He acknowledged that in such cases, negotiating a single, shared REMS “can extend for long periods of time.”

To mitigate that issue, the draft guidance says FDA “will initiate discussions about the formation of a shared system REMS” under certain circumstances:

• "When FDA has received an ANDA [abbreviated new drug application] that references an RLD [reference listed drug] that has a REMS with ETASU [elements to assure safe use];
• When FDA has received an NDA [new drug application] or a BLA [biologic license application] for a product that references an NDA or a BLA that is subject to REMS with ETASU, and has determined that the proposed product also would require the same ETASU
• When FDA has determined for drugs and biologics in a class with similar, serious risks that a shared system REMS may minimize the burden of having multiple unique REMS programs."

The agency said it will, according to the 11-page draft, “request that applicants of the pending applications submit an authorization for disclosure that will allow the Agency to hold meetings between multiple applicants. FDA will provide contact information for the product being referenced by the pending applications to facilitate the development of a shared system REMS.”

And though FDA noted that it “does not advise on the business arrangements being negotiated or arbitrate substantive disputes about the terms of contracts,” the agency “will set forth expectations of the applicants for the development of the shared system REMS, which may include suggested timeframes for various milestones in the process of developing the shared system, and the process for submission of the proposed REMS. FDA may facilitate collaborations between applicants when necessary to achieve a shared system REMS. For example, FDA may host teleconferences to encourage communications between applicants.”

Applicants developing a shared system REMS also “should submit their REMS by application midpoint for pending applications, or another time frame specified by the Agency. To facilitate submission tracking, FDA recommends that shared system REMS applicants work together to coordinate their submissions on the same day, if possible,” the draft adds.


The other draft guidance describes how and when FDA will consider waiving a single, shared system requirement, and how generic drug applicants can request a waiver.

“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 (either upon request of the applicant, or on the agency’s own initiative),” Gottlieb said in a statement.

He also said FDA may waive the single, shared system REMS requirement and permit the generic company to use a “different, comparable” aspect of the ETASU “if the agency finds that (1) the burden of forming a single shared system outweighs the benefits of having one, or (2) 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.”

The draft guidance also provides recommendations to generic drug applicants regarding how to submit and what should be included in waiver requests. 

Comments on both draft guidance documents can be submitted in the next 90 days. The generic drug industry's lobbying arm, Association for Accessible Medicines, said in a statement Thursday: "AAM applauds FDA for issuing these guidances to address one form of brand gamesmanship that has delayed generic and biosimilar competition and price reductions for patients. Calls for voluntary action by brand companies to stop their efforts to thwart generic competition are not enough."

Development of a Shared System REMS: Draft Guidance for Industry

Waivers of the Single, Shared System REMS Requirement: Draft Guidance for Industry

Regulatory Focus newsletters

All the biggest regulatory news and happenings.