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FDA sets record for generic drug approvals
WASHINGTON — 2016 was a record-setting year for the U.S. Food and Drug Administration’s generic drug program, with its Center for Drug Evaluation and Research generating the highest number of approvals in its history — more than 800 generic drug approvals, including both full approvals and tentative approvals.
Last year’s performance surpassed 2015’s previous record of 726. Many of these approvals were for “first-time generic drugs,” meaning the introduction of a generic counterpart for a brand-name product for which there was previously no generic. That’s typically the first step towards lower drug prices because multiple generic versions of brand-name drugs drive price competition, leading to more affordable drugs.
“We also are making a significant effort to spur generic drug development,” according to an FDA report written by Kathleen “Cook” Uhl, M.D. “For example GDUFA Regulatory Science priorities contribute valuable research to generic drug development. Our efforts are geared to helping the generic drug industry develop validated scientific methods for demonstrating bioequivalence and assuring therapeutic equivalence to the brand-name counterpart.”
The FDA did acknowledge much needs to be done regarding generic drugs, however. “Despite these developments in 2016, a lot remains to be done as we approach the end of our first-ever five-year GDUFA program. We look forward to working with industry, the research community, physicians, lawmakers, and other stakeholders to help American consumers and advance use of generic drugs in our nation’s health care system.”
APhA names inaugural Ton Hoek Scholarship winner
WASHINGTON — The American Pharmacists Association named Valerie Nolt, PharmD, as the inaugural recipient of the Ton Hoek Scholarship.
The Ton Hoek Scholarship provides a stipend for a student pharmacist, fellow, resident, or PharmD graduate pursuing graduate studies to attend the International Pharmaceutical Federation World Congress. Nolt, a post-graduate year one pharmacy resident at the University of Kentucky, received her Doctor of Pharmacy degree from the University of Pittsburgh School of Pharmacy. As a student pharmacist, she was actively involved with the International Pharmaceutical Students’ Federation through her membership in APhA-ASP. Nolt fostered her interest in global health through pharmacy practice experiences in Turkey, Portugal, and Guatemala.
“Although I will, unfortunately, never have the opportunity to meet Ton Hoek, it is with great respect that I accept this scholarship in his honor. He has been described as consistently cheerful, deeply committed to the profession, and invested in the promotion of global advancement of pharmacy. The receipt of this scholarship is incredibly meaningful in supporting my attendance at the International Pharmaceutical Federation World Congress, which will allow me to continue exploring the network of international pharmacy and learning how I can advance global health initiatives throughout my career,” said Nolt.
Nolt will be recognized at the APhA Foundation Contributors’ Breakfast during the 2017 APhA Annual Meeting and Exposition in San Francisco on Monday, March 27.
The Ton Hoek Scholarship was established to memorialize Mr. A. J. M. (Ton) Hoek’s commitment to the global community of pharmacists. In his role as CEO and General Secretary of FIP, Hoek (1955-2012) built many global relationships in the pharmacist community. His leadership efforts resulted in positive collaboration for FIP, both within pharmacy and at the broader level of world health.