Statement by Ralph G. Neas, President and CEO, GPhA, Regarding the FDA's and Generic Industry's Shared Commitment to Quality Culture

PRESS RELEASE

MIAMI, FL and WASHINGTON, DC (February 11, 2015) — Today, an expert panel at the 2015 Generic Pharmaceutical Association (GPhA) Annual Meeting, “FDA and Industry Perspectives on Quality Culture,” convened to discuss a shared commitment with industry to the highest standards of manufacturing quality and regulatory processes.

Following Dr. Janet Woodcock’s presentation on the topic, an industry panel moderated by Deborah Autor, Strategic Global Quality and Regulatory Policy, Mylan Inc., featured Frances Zipp, President, Lachman Consultants and Marty Murawski, Vice President, Quality Systems, Hospira, Inc.

“GPhA applauds the FDA commitment to creating and prioritizing a quality culture,” said Ralph G. Neas, President and CEO, GPhA. “We welcome the Agency’s focus on quality, including and its work to enhance inspection protocol. GPhA applauds the Agency’s strides toward process improvements and structural evolution, both of which contribute to more meaningful interaction between industry and regulatory partners.

We are optimistic that these efforts will enhance quality and help reduce the growing backlog of generic drugs awaiting review and approval at FDA, which is now approaching 4,000 applications, according to a keynote speech delivered earlier this week by Dr. Kathleen Uhl, Director, Office of Generic Drugs at the FDA. GPhA looks forward to continuing to collaborate with FDA on a more predictable, transparent process for generic drug review and approval.

GPhA member efforts to sustain a quality culture are at the center of a deep commitment to quality manufacturing. This commitment drives business operations and is integral to the industry’s top priority — patient safety. Today’s panel is a strong testament to our shared goals –enhanced quality management systems and continuous improvement which enables access to safe, effective, high-quality generic medicines for millions of people.”

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.