GPhA responds to FDA: User fees okay in exchange for more favorable treatment

The Generic Pharmaceutical Association (GPhA) issued a quick response to FDA's suggestion that it pay user fees to help support the Office of Generic Drugs (OGD), whose resources have been increasingly taxed in recent years. Fine, GPha says, as long as the Agency would support legislation to bring generic drug products to market faster. "Providing a minimal amount of additional funding for the Office of Generic Drugs (OGD) will provide a tremendous return on investment, resulting in long-lasting dividends to all health care purchasers and health care programs, GPhA said. What follows is the rest of the organization's statement: "A modest investment in OGD -- such as $15 million -- would help to make more affordable medicines available to consumers and public and private health care purchasers, who would save billions of dollars," said GPhA President and CEO Kathleen Jaeger. "Those savings also would enable the administration to reach more Americans through its priority healthcare initiatives, such as Medicare, Medicaid and programs to improve children's health care, assist the chronically ill, and fight AIDS." Generics, which cost 30% to 80% less than brands, save consumers and public and private health care purchasers billions of dollars each year. Medicare, for example, anticipates that its prescription drug benefit will cost $8 billion less than anticipated, due in part to the use of affordable generic medicines. And, just a one percent increase in the use of generics nationwide would save $4 billion annually. At GPhA's Annual Meeting, the Food and Drug Administration (FDA) expressed interest in exploring user fees for generics. But Jaeger pointed out that "the purpose of brand company user fees is to ensure a faster approval process for applications. The real issue for generics, however, is whether consumers will receive those products in a more timely fashion. Unlike applications from brand or medical device companies, generic applications are subject to an intellectual property-based approval system. This system is fraught with unintended legal and regulatory loopholes." Jaeger continued, "Given this environment, the generic pharmaceutical industry would consider paying user fees if the FDA and the Bush administration would endorse legislative and other changes that the industry believes would speed its products to market." "Congress needs to take steps now to provide additional funding for OGD. While FDA and others continue to debate user fees, the backlog at OGD continues to grow, denying consumers access to affordable medicines," said Jaeger. OGD's workload has increased by 36%, and the department currently has a backlog of more than 800 generic drug applications. That number that is expected to increase as more than $100 billion in brand products are expected to lose patent protection by 2010. 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. For more information about the industry, visit www.gphaonline.org. -- PWT