BOCA RATON, Fla., Feb. 17 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) kicked off its Annual Meeting today by outlining its policy priorities for 2006. Priorities include the codification of a flexible and definitive abbreviated approval process for generic biopharmaceuticals, a halt to the practice of authorized generics, the creation of a biodefense pharmaceutical sector, and thoughtful reform of the Medicaid program.
"Generic medicines are a vital part of ensuring that health care will remain affordable and accessible to all Americans," said GPhA President and CEO Kathleen Jaeger, speaking at the Association's Annual Meeting in Boca Raton, Florida. "Given the enormous pressure to hold down costs in the U.S. health care system, it's clear that the generic industry will continue to play a key role in leading America into a healthy future.
"In 2006, we will continue to work with Congress and the administration to address policies that could hinder efforts to balance innovation with access and reduce costs for consumers, providers and purchasers," Jaeger added.
In 2006, GPhA will focus on the following issues:
Generic biopharmaceuticals: GPhA is urging FDA to approve generic biopharmaceuticals under a definitive, flexible, and abbreviated approval pathway. The Association has urged FDA to issue its guidance documents and white paper and asked Congress to instruct FDA to approve affordable generic biopharmaceuticals.
Authorized generics: These are identical drug products that are made by a brand company, yet sold as a generic product either by the brand's subsidiary or a third-party generic distributor. The FDA treats authorized generics as "brand products" for purposes of product approval and thus, allows them to compete with generic products awarded 180-day exclusivity. By devaluing the 180-day exclusivity, generic companies will have less incentive to undertake patent challenges, resulting in higher drug prices for consumers. GPhA is encouraging Congress to reevaluate FDA's treatment of authorized generics.
Biodefense: Congress is currently considering legislation that would enhance bioterrorism preparedness. While GPhA supports the general goal of the legislation, it opposes provisions such as unlimited patent extensions and market exclusivities for everyday medicines that would needlessly block consumers' affordable medicines from coming to market.
Medicaid Reform: As Congress and state governments work to rein in growing Medicaid expenditures, increased generic utilization will be a vital part of reducing costs. GPhA is encouraging states to adopt measures such as generics- first programs with written justification; the elimination of state carve- outs; prescription pad redesigns; and consumer education campaigns. Just a one percent increase in generic utilization could save Medicaid $475 million annually.
Jaeger acknowledged that GPhA will be faced with other challenges during 2006, such as funding for the Office of Generic Drugs, whose workload is continuing to increase, and fighting for the balance between access and innovation in free trade agreements.
Further information about all of these issues, including GPhA's new annual report, is available online at www.gphaonline.org under the "Issues" tab. GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 53% of the total prescriptions dispensed in the United States, but less than 12% of all dollars spent on prescription drugs.
Generic Pharmaceutical AssociationCONTACT: Andrea Hofelich, +1-703-647-2495, or cell, +1-703-944-3137
Web site: http://www.gphaonline.org/