WASHINGTON, D.C. (July 28, 2022) – The Association for Accessible Medicines (AAM) announced today that David Gaugh has been promoted to Executive Vice President for Sciences & Regulatory Affairs.
David recently represented the generic and biosimilar medicine industries in the complex multilateral negotiations over FDA user fees which will, upon Congressional approval, extend the program that has saved American patients and the health care system over $2 trillion through the increased use of generic and biosimilar medicines over the last decade. This is the third time that David has led Generic Drug User Fee Amendments (GDUFA) and Biosimilar User Fee Act (BsUFA) negotiations on behalf of the industry. David testified before the United States Senate earlier this year regarding the user fee reauthorization and has appeared before Congress and the FDA countless times as an industry expert and resource over the course of the last decade.
David’s leadership through multiple rounds of negotiation and reauthorization of GDUFA and BsUFA have brought incalculable value to both industry and American patients, said Dan Leonard, President & CEO of AAM.
But beyond that, his unparalleled knowledge of the prescription medicine ecosystem, from raw materials to manufacturing to the pharmacy counter, is a tremendous asset to AAM and our ability to advocate effectively for enhanced patient access to safe, affordable, and effective generic and biosimilar medicines. The Board of Directors and I are pleased to announce his promotion to Executive Vice President and look forward to relying on his sage counsel for years to come.
David joined the Association for Accessible Medicines in 2012 as the Senior Vice President for Sciences and Regulatory Affairs, where he is responsible for the professional liaison functions between member companies, agencies of the U.S. government and legislative bodies for all responsible areas. Prior to joining AAM, David was Vice President and General Manager of Bedford Laboratories, a Division of Ben Venue Laboratories and a wholly owned subsidiary of Boehringer Ingelheim.
David is a registered pharmacist and has been engaged in several board-level pharmacy-related activities such as the American Society of Health-system Pharmacists Education and Research Foundation Board of Directors, USP Council of Convention, and American Foundation for Pharmaceutical Education Board of Directors.
AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 18 percent of total drug spending.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.