GPhA Annual Meeting - Ramping Up to Take On Specialty Pharmaceuticals and Biologics Without Sacrificing Quality But Holding Onto Pay-for-Delay and Labeling Preemption - Day Two (Part One of Three)
On February 20-22, 2013, the Generic Pharmaceutical Association ("GPhA") held its 2013 Annual Meeting attracting over 600 attendees to see how the nation's health and regulatory issues will impact the generic industry and consumers who use generic medicines. While some events are for GPhA members only, a majority of the events are open to all attendees and were held in a single room or exhibit hall. Most of the main events were held in a slickly-decorated room filled with stars, comets, and planets.
While the Meeting covered a lot of territory, recurrent themes appeared to emphasize that the generic industry has come of age, where it joins its big-pharma brothers in having an office on par level with the Office of New Drugs ("OND") in FDA's Center for Drug Evaluation and Research ("CDER") and now pays user fees to speed up generic drug approvals. GPhA's members announced that they are ready to develop high quality generic versions of specialty pharmaceuticals and biologics, some of which may require the expenditure of hundreds or more millions of dollars to develop, obtain approval for, and market. At the same time, GPhA appears to hold onto the notions that that they can continue to settle cases with reverse payments that the Federal Trade Commission ("FTC") views as so-called "pay-for-delay" settlements that are presumptively anticompetitive. GPhA also believes that manufacturers should be allowed to sell generic versions of products with the same labeling as the innovator, when the innovator or generic companies that manufacture and sell the product are aware of safety information not presently included in the FDA-approved labeling.
Kicking off the meeting with a "State of the Association", GPhA President and CEO Ralph G. Neas described generic drugs as the "backbone of the pharmaceutical industry." Neas expressed the Association's confidence that FDA will "come through" and help the industry understand what will be expected of it to develop biosimilars and interchangeable biosimilars, which are the future to save lives and money.