Congress Urged to Keep the Current Risk Evaluation and Mitigation Strategies (REMS) Program Intact

New Policy Paper Finds REMS Are Rare; Give Patients Access to Medicines That Would Otherwise Not Be Available

Jan 21, 2016, 11:03 ET from Aimed Alliance

WASHINGTON, Jan. 21, 2016 /PRNewswire-USNewswire/ -- Eight years after Congress gave the U.S. Food and Drug Administration (FDA) authority to require Risk Evaluation and Mitigation Strategies (REMS) for higher risk medicines, a new policy paper credits this drug safety system with bringing to market needed medicines for many serious diseases and rare disorders that would likely never have been approved without REMS protocols to ensure their safe use.

Authored by researchers with the Alliance for the Adoption of Innovations in Medicine (Aimed Alliance) and published in the Journal of Pharmaceutical Policy and Practice, the paper dispels common misperceptions about the need for REMS programs, including the allegation that REMS protocols and, in particular, restricted distribution systems impede generic drug development.

Based on a comprehensive review of FDA's REMS policies since 2007, the paper – Don't Sell out Safety: A Call To Preserve Risk Evaluation and Mitigation Strategies To Reduce Harm To Patients and the Public in the U.S. – documents that REMS are rare and only authorized to prevent life-threatening complications, birth defects, severe allergic reactions, and infections resulting from the inappropriate use or handling of higher risk drugs. Moreover, the paper reports that nearly a dozen medicines subject to REMS have gone generic, including nine requiring stringent safety precautions called "Elements to Assure Safe Use" (ETASU) provisions, and a number of "abbreviated new drug applications" for new generic medicines carrying REMS controls have been filed with FDA.

"Although REMS have become an essential regulatory tool to advance patient safety, enough time has passed that policymakers may have forgotten the sense of urgency that was behind the creation of this program," said Stacey L. Worthy, Public Policy Director for the Aimed Alliance and one of the paper's authors. "It is time for an informed discussion about the meaningful impact of REMS to ensure the safety protections and patient access to innovative medicines afforded through REMS safeguards will remain intact."

Also dispelling the pervasive myth that a large number of new medicines are subject to REMS controls, the paper presents detailed evidence that the REMS program has evolved over time to concentrate on mitigating the public health risks of the most dangerous drugs. The result is that today, 73 medicines – or 6 percent of the 1,161 brand drugs approved by FDA as of October 2015 – have authorized unique REMS programs and six drug classes exist in shared REMS systems. Of these REMS drugs, only 36 are subject to the more restrictive "Elements to Assure Safe Use" (ETASU), and an even smaller number require restricted distribution systems to meet the terms of these REMS programs.  

At the same time, the paper lays out the consequences to patient safety of weakening the current REMS system. Here, the paper focuses on proposed legislation, such as the Fair Access to Safe and Timely (FAST) Generics Act of 2015, to force the sale of medicines carrying serious risks to generic marketers for clinical (bioequivalence) testing, the first step needed for FDA approval.

Cautioning that bills such as the FAST Generics Act present significant safety risks that should not be overlooked, the paper cites a number of provisions that undermine necessary drug safety precautions and make it easier for potentially dangerous drugs to get into the wrong hands. These provisions include:

  • Forcing innovators to sell drugs subject to the most rigorous REM controls (ETASU) without the same safeguards to ensure safe use.
  • Defining an "eligible product developer" able to obtain high-risk branded medicines for bioequivalence testing as any person or entity that seeks to develop a generic drug.
  • Allowing wholesalers and distributors to sell large quantities of REMS drug samples without safety precautions.
  • Preventing brand manufacturers from learning the identity of the company or individual receiving the company's REMS drug and, therefore, impeding the manufacturer's ability to monitor and track the use of this potentially dangerous medicine.
  • Allowing the FDA limited time to authorize the forced sale of drug samples to "eligible product developers." If the agency is not able to act in time, authorization would be automatic.

Guided by the belief that guarding patient safety and increasing generic drug development are not mutually exclusive, the Aimed Alliance paper proposes policies that preserve REMS safeguards while making it easier for brand manufacturers to negotiate with generic companies based on certain agreed upon responsibilities and liabilities under the FDA's continued oversight. Specifically, the paper calls for REMS policies that:

  • Hold all drug manufacturers – branded and generic – to the same safety requirements when designing and conducting drug studies, including bioequivalence testing.
  • Allow brand and generic manufacturers to negotiate the terms under which product samples are provided for bioequivalence testing.
  • Support shared decision-making between brand and generic manufacturers to implement a single, shared REMS program.
  • Preserve the intellectual property rights of innovator companies when implementing REMS policies.

About the Alliance for the Adoption of Innovations in Medicine

The Alliance for the Adoption of Innovations in Medicine (Aimed Alliance) is a tax-exempt, not-for-profit organization that seeks to improve health care in the United States by supporting the development and utilization of novel, evidence-based treatments for rare disorders, chronic diseases, and medical conditions. Aimed Alliance achieves this mission by conducting research and providing analysis on patient access to innovative treatments; developing patient-centered policy recommendations; and collaborating with like-minded patient advocacy and professional groups. For more information, visit and follow @AdoptInnovation on Twitter.


SOURCE Aimed Alliance