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Statement by Chip Davis, President and CEO, GPhA, Regarding REMS Misuse

Contact: Steve Arnoff 202.249.7113

WASHINGTON DC, (October 6, 2015) – “The Generic Pharmaceutical Association (GPhA) strongly supports the use of Food and Drug Administration (FDA) approved Risk Evaluation and Mitigation Strategies (REMS) to protect patient safety and to take precautions against severe side effects or adverse events. GPhA also supports FDA efforts to engage in a dialogue on ways to improve REMS and ensure patient access to drugs that are subject to REMS programs.

When used as intended by brand and generic manufacturers, REMS programs are important to safeguard patients against potential risk factors that may be associated with new medicines. However, some brand companies abuse REMS and other restricted access programs to prevent generic companies from gaining access to brand drug samples needed for the bioequivalence testing that is necessary to gain FDA approval, creating barriers to patient access to affordable medicines.

Exploiting regulatory loopholes at patients’ expense is a maneuver that costs the U.S. health system $5.4 billion annually. It is estimated that delayed biosimilar entry from restricted access could result in $140 million in lost savings for every $1 billion in biologics sales, according to a report by Matrix Global Advisors.

That is why GPhA and a diverse group of industry and health stakeholders continue to urge passage of the FAST Generics Act, a bill introduced by Rep. Steve Stivers (R-OH) and Rep. Peter Welch (D-VT) that would strengthen REMS, closing these loopholes without lowering FDA safety standards. The FAST Generics Act sets forth more explicit legal requirements and processes for the acquisition of product samples by generic and biosimilar developers, at the same time enhancing the safeguards in place to protect public health.

Congress, the FDA, the generic drug industry and a broad range of partners from all corners of the supply chain agree on the need to address these abuses. The FAST Generics Act equips FDA with the tools to ensure that this happens.”

Industry and Stakeholder Support for the FAST Generics Act
Lost Prescription Drug Savings from Use of REMS Programs to Delay Generic Market Entry (Matrix Global Advisors, July 2014)

About GPhA
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at Follow us on twitter: @gpha.