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Statement by Ralph G. Neas, President and CEO, GPhA, Regarding Proposed Legislation on Generic Drugs


Steve Arnoff



WASHINGTON, DC (November 20, 2014) –

“This legislation once again misses the forest for the trees. In actuality, generic drugs continue to be a resounding success in lowering health care costs and benefiting patients. Indeed, generics saved $239 billion in 2013 (a 14% increase in savings from 2012) and more than $1.46 trillion over the recent decade. Further, the Express Scripts 2013 Drug Trend Report issued in 2014 shows that since 2008, the price of brand drugs has almost doubled, but the price of generic drugs has been cut roughly in half.

Unfortunately the newly proposed legislation makes it clear that the hearing was not intended to be meaningful examination of ways to ensure savings. The proposed bill reflects a basic misunderstanding of the pharmaceutical marketplace, and attempts to impose brand pharmaceutical provisions on generic drugs. This effort is misguided and will threaten patient access to affordable medicines.

We believe that the best way to increase access and lower prices is to encourage competition. Congress should focus on several areas where swift action would facilitate a more competitive marketplace:

• First, in partnership with the industry, Congress should encourage the timely FDA review of the more than 3,000 generic drug applications that have been filed with the agency. Once those are approved, consumers will have more options than ever, and that will help drive down prices.

• Secondly, Congress should increase scrutiny of the misuse of safety programs designed to protect patients that are instead being used to thwart competition from generics. A recent study by Matrix Global Advisors estimates that efforts to subvert the intent of programs like Risk Evaluation Mitigation Strategies (REMS) and use them as a means to prevent competition comes at a cost of $5.4 billion to the health system.

These issues represent concrete ways that Congress could act today to provide American consumers with more choices, greater access to medicines, and billions of dollars in increased generic savings.”

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.