The Institute for International Research held its annual Generic Drugs Summit on June 18-20, 2008, in Washington, DC. With billions of dollars in patent expirations looming over the next couple of years, the pharmaceutical industry as a whole is at an inflection point. With the scarcity of the next blockbuster drug on the horizon, what impact will this have on the future of generic drugs firms’ bottom line? How do the latest outcomes in patent settlements between innovators and generic firms affect business? What does Wall Street have to say about the current and future outlook on the generic drugs industry? The conference will address these and other issues that are driving the industry.
On June 20, Foley Partner and Life Sciences Industry Team Co-chair David Rosen participated in the session, “Examine the Past, Present and Possible Future of Proving Equivalency for Topical and Locally Acting Oral Generics.” This session offered an understanding of the FDA’s methods and practices of determining bioequivalence for topical and locally acting oral generics. Historically, these products have created more of a challenge than would be expected given the scientific methods employed by the agency. This panel investigated how the regulatory approval procedure has evolved and provided insight regarding how the process may progress moving forward.
For more information about the Generic Drugs Summit, please visit the Institute for International Research Web site.
