Statement by Ralph G. Neas, President and CEO, GPhA, Regarding the Selection of Kathleen Uhl, M.D. as Director, Office of Generic Drugs (OGD)

PRESS RELEASE

WASHINGTON, DC (January 16, 2015) —

“The Generic Pharmaceutical Association (GPhA) and its members congratulate Kathleen “Cook” Uhl, M.D. on her selection as permanent director of the Office of Generic Drugs (OGD).

In Dr. Uhl’s capacity as Acting Director thus far, she has worked tirelessly to ensure the building of a strong foundation that will lead to timely access to safe and effective generic drugs. GPhA is hopeful that under Dr. Uhl’s leadership the FDA will continue to improve communications and transparency between the agency and generic drug manufacturers, particularly as we collaborate on the implementation of the Generic Drug User Fee Act (GDUFA), among other priorities.

The Association looks forward to Dr. Uhl’s ambitious plans translating to meaningful action in 2015, particularly the establishing of target action dates for more than 3,500 filings. As always, GPhA and its member companies remain an enthusiastic partner in FDA efforts to boost generic drug safety, transparency and access — the core goals of GDUFA. We look forward to continuing our work together in order to ensure generic drug quality and availability, and improve the process responsible for delivering more affordable generic medicines to people who need them.”

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