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Statement by Chip Davis, President and CEO, GPhA, Regarding the Strengthening of REMS

Contact: Steve Arnoff  202.249.7113 

WASHINGTON, DC (October 22, 2015) — “The Generic Pharmaceutical Association (GPhA) strongly supports Food and Drug Administration (FDA) approved Risk Evaluation and Mitigation Strategies (REMS) to protect patient safety. GPhA and many patient and disease advocacy groups share a goal to ensure patient access to affordable medicines. However, this goal is compromised each time that a brand drug company exploits REMS or restricted distribution systems to delay access to generic drugs.

GPhA welcomes the opportunity to engage with patient groups and others to see that REMS programs are strengthened and used as intended. Yet, some groups are calling for the preservation of the loopholes that make it harder for the very patients they represent to access affordable medicine.

GPhA and a broad range of industry and health stakeholders continue to urge Congress to pass the Fair Access to Safe and Timely (FAST) Generics Act introduced by Reps. Steve Stivers (R-OH) and Peter Welch (D-VT). This bill strengthens REMS for patients by closing regulatory loopholes used by some brand drug manufacturers to block generic competition without lowering safety standards.

The FAST Generics Act sets forth more explicit legal requirements and processes for the acquisition of product samples by developers of generic drugs and biosimilars, while at the same time enhancing the safeguards in place to protect public health.

REMS misuse costs the U.S. healthcare system $5.4 billion annually. Experts also estimate 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.

GPhA welcomes the new Patients Alliance for Drug Safety Protections to join us in ensuring that REMS and similar programs are not misused as barriers to patient access to affordable medicines, and looks forward to continuing the conversation with members of Congress, the FDA and others to address this issue.”

Resources:
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 www.gphaonline.org. Follow us on twitter: @gpha.