U.S. Government and Generic Drugs: Faster and Cheaper

On June 12, 2003, President Bush, the Food and Drug Administration Commissioner and the Secretary of Health and Human Services announced new regulations and review procedures to expedite the process for bringing generic drugs to market. The new regulations - termed the Final Rule – are designed to accelerate the availability of generic versions of brand name drugs to consumers. Coming into force on August 1, 2003, the Final Rule: (a) allows a maximum of one 30-month stay for a brand name, or innovator, drug manufacturer to resolve allegations that a generic drug maker is infringing a listed drug patent; (b) clarifies the types of patents that can and cannot be submitted to the FDA for listing in the Orange Book; and (c) revises the information required to be submitted on patents. The new review procedures are also intended to reduce the time for determining the safety and efficacy of a new generic drug. The FDA estimates that over the next few years the total time to approve most new generic drugs will be reduced by 3 months. President Bush's announcement came one day after the Senate Committee on Health, Education, Labor, and Pensions approved The Greater Access to Affordable Pharmaceuticals Act of 2003 ("GAAP"). Similar to the FDA's new regulations, GAAP limits innovator drug manufacturers to one 30-month stay of FDA approval for any new generic drug subject to a patent infringement action by the innovator. GAAP also requires pharmaceutical companies to register their patents with the FDA within 30 days of approval. The failure to do so is a bar to civil actions for patent infringement. Similarly, the GAAP makes the failure to timely file a civil action for infringement a bar to a later action. Anti-competitive deals between generic and brand name manufacturers are specifically penalized. Evidence of such deals results in the forfeiture of the 180-day marketing exclusivity period traditionally granted to generic manufacturers first to apply for FDA approval. For more information on this topic, visit: http://www.fda.gov/oc/initiatives/generics/ http://makeashorterlink.com/?A3C6230F4 Summary by: Lenni Carreiro