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Gordon Johnston is Vice President of Regulatory Sciences at the Generic Pharmaceutical Association. In this role, he serves as the primary industry spokesperson on regulatory matters that impact the generic drug industry.
Johnston has more than 25 years of experience in the pharmaceutical industry, beginning with the U.S. Public Health Service, where he served in a number of pharmacist and health care management positions. In 1987, he was assigned to the Food and Drug Administration (FDA) and in 1994, was promoted to be Deputy Director of the FDA’s Office of Generic Drugs (OGD). The OGD is responsible for the review and approval of all generic drugs in the United States. During his tenure at the federal agency, Johnston was a key member of the FDA team that developed and put into practice the regulations implementing the Hatch-Waxman amendments. While at the FDA, Johnston interfaced with a number of foreign governments on generic drug regulatory standards.
Following his retirement from the FDA in 1999, Johnston served as a consultant to the pharmaceutical industry. He also has spoken at numerous national and international meetings on regulatory and technical issues related to generic drugs.
Johnston holds a bachelor’s degree in pharmacy from the University of Nebraska and a master’s degree in health care administration from the University of Oklahoma.