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Statement from Ralph G. Neas, President and CEO, GPhA, Regarding the FDA’s Public Hearing on GDUFA

Contact: Claire Sheahan 202-249-7110

FOR IMMEDIATE RELEASE

WASHINGTON, DC (September 17, 2014) – “Today, more than 50 individuals representing the generic drug industry and more than 20 Generic Pharmaceutical Association (GPhA) member companies stand together to call attention to areas where the Generic Drug User Fee Act (GDUFA) process and implementation can be strengthened.

Access to generic drugs is a public health good. Generics put life-saving and life-changing medications in reach for millions of Americans. Generic drug savings are a boon for patients, taxpayers, businesses, government and all who rely on access and choice when it comes to more affordable medicine. In fact, in 2013 alone, generic drugs were responsible for $239 billion in savings for the U.S. health system, according to the recently released 2014 Generic Drug Savings in the U.S. report. These savings must be sustained and the voice of the generic drug industry must be heard.

The generic industry works closely with FDA to improve access to generic drugs. GDUFA is a historic achievement for both FDA and the generic pharmaceutical industry. The association and its members fully support GDUFA objectives with 100 percent industry-generated funds. In fact, last year the industry contributed $300 million to support the three core public health aims of GDUFA: safety, access and transparency. For GDUFA to be successful it must be implemented in a way that is mindful of the realities of the generic drug marketplace, and continues to incentivize the development of generic drugs for patients.

Today, GPhA welcomes the opportunity to share collective feedback from its member companies on future FDA policy priorities, a dialogue that is particularly important as GDUFA metrics will apply starting October 1, 2014 and as GDUFA II negotiations draw near.

As the FDA develops fiscal year 2015 priorities, it will be important to accelerate review activities to meet our shared goals. GPhA also urges FDA to dedicate resources to address the enormous and growing backlog of Abbreviated New Drug Application (ANDA) and Prior Approval Supplement (PAS) submissions.

GPhA looks forward to the continued dialogue on improving GDUFA, particularly efforts to make generic drug approvals more predictable and consistent. This could include more communication with applicants and continued meaningful interaction with the generic industry during agency development of new guidance or before agency enforcement of draft guidance as final.

Working together with our regulatory partners, we can ensure that timely access to safe and effective generic drugs continues for millions of people.”

To view the GPhA presentation slides, visit:http://www.gphaonline.org/media/cms/GPhA_GDUFA_Policy_Development_PPT_-_Part_15_Hearing_09-17-2014_1.pdf

For details on the hearing, visit: www.fda.gov/Drugs/NewsEvents/ucm409381.htm

For more information about the generic drug industry and GDUFA, visit www.GDUFAnow.org.

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.