The Generic Pharmaceutical Association (GPhA) today kicked off its 2007 Annual Meeting by calling on Congress to move forward with legislation to bring safe and effective biogenerics to patients in need and remove barriers that delay consumer access to affordable generic medicines.

In her opening remarks, GPhA President and CEO Kathleen Jaeger encouraged Congress to approve the Access to Life-Saving Medicine Act, bipartisan legislation that would mandate that the Food and Drug Administration (FDA) create a clear and efficient abbreviated approval pathway for generic versions of biopharmaceuticals. Biopharmaceuticals are everyday medicines used to treat conditions like heart disease, multiple sclerosis and cancer, but their costs are exceedingly high, sometimes as much as $200,000 per patient, per year.

"We are on the verge of a new revolution in our industry -- the creation of a science-based pathway for the approval of safe and effective biogenerics," said Kathleen Jaeger, GPhA President and CEO.

"Under the Access to Life-Saving Medicine Act, safety is and always will be the number one priority. That's why we support the approval pathway created in this legislation that gives the FDA the authority and flexibility it needs to ensure safety and efficacy as well as more timely access to affordable biogenerics.

"It will apply the most advanced scientific methods," she added. "And similar to brand products, it defers to FDA's scientific judgment regarding appropriate approval requirements on a product-by-product basis.

"The need is compelling. Biopharmaceutical products are expensive, and generic versions of brand biopharmaceutical products can -- and will -- offer consumers billions of dollars in savings," Jaeger said.

Jaeger also discussed the need to remove barriers to market entry, such as authorized generics and citizen petitions, which are undermining Congressional intent by needlessly creating significant delays in getting generic medicines to consumers faster. In addition, Jaeger noted that Congress will be faced with the reauthorization of major legislation that will ultimately affect consumer health care costs and access, including the Prescription Drug User Fee Act, the Pediatric Research Equity Act, and the Best Pharmaceuticals for Children Act and Trade Promotion Authority.

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. Unbranded and branded generics represent 63% of the total prescriptions dispensed in the United States, but only 20% of all dollars spent on prescription drugs. For more information about the industry, visit gphaonline.