Stephen Mason, a former Director of Government Relations at the Generic Pharmaceutical Association (GPhA) is joining the Food and Drug Administration (FDA) as a Senior Advisor in the agencys Office of Legislation, effective November 13, 2006.

In this role, Stephen will work closely with David Boyer, Assistant Commissioner for Legislation, on a wide variety of issues pending before Congress, most notably generic drug legislation.

Stephen will be a valuable asset to the agency, said Acting Commissioner of Food and Drugs Dr. Andrew C. von Eschenbach. His legislative experience combined with his knowledge of the regulatory process will play a vital role in advancing and communicating the agencys public heath agenda to our nations legislators."


Stephen comes to FDA after an accomplished and diverse career in both regulated industry and on Capitol Hill. While serving at GPhA, he was a leader in advocating for the associations priorities in Congress and the Administration. He was instrumental in the development of generic drug policy issues as well as organizing coalition and outreach efforts surrounding federal policy issues.

Prior to joining GPhA, Stephen held several other positions including Legislative Aide to Congressman John Ensign. In this position he directed legislative issue management and fostered policy development on an array of issues, including health care.

Stephen earned a Bachelor of Science, Business Administration-Finance at Oakland University in Rochester, MI.

Generic drugs play an important role in providing access to affordable products that will benefit the health of consumers and, on average, FDA approves more than one generic drug product a day. Recently FDA has taken a number of significant steps to provide greater access to affordable prescription medications, including a number of technological advances to the generic review process that directly affect sponsor applications and ultimately FDA review time. For example, the agency is now utilizing a cluster approach to reviewing applications submitted at the end of a products 5 - year new chemical entity (NCE) exclusivity to increase efficiency and decrease review time.

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