KOHL PRESSES FDA CHIEF ON GENERIC DRUG APPROVAL BACKLOG


Today, U.S. Senator Herb Kohl (D-WI) urged Acting Food and Drug Administration (FDA) Commissioner Dr. Andrew Von Eschenbach to expedite the generic drug approval process, which has slowed significantly the last two years.

Generic medicines offer affordable alternatives to pricier name-brand drugs, reducing the financial burden on both senior citizens and the government health programs that serve them. According to the FDAs FY07 budget, the average review time for generic drug applications stands at 17.5 months, a stark contrast to the 8.5 month review time for new brand name drugs.

While the FDA plans to spend well over $400 million to approve approximately 88 new brand-name drugs, the agency only plans to spend $65 million to approve 400 new generics in the coming year, Kohl said. While I understand the importance of reviewing and approving new, breakthrough drugs, generics bring you a big bang for your buck.

Kohls questions in todays hearing come on the heels of a letter he sent last month to Health and Human Services Secretary Mike Leavitt citing a Washington Post article, which reported that the FDA had a backlog of more than 800 generic drug applications an all-time high.

Concerned that the FDAs proposed budget included a $7 million cut to the Human Drugs Program, which includes funding for the generic drugs program, Kohl asked Secretary Leavitt for a full report on the FDAs efforts to address this growing backlog.

Kohl added: We have to do more to bring these affordable alternatives to the market. They will help individuals cope with soaring health care costs and help the federal government save money in Medicare and Medicaid.

Kohl is the Ranking Member of the Senates Special Committee on Aging and senior Democrat on the Agriculture Appropriations Subcommittee, which has jurisdiction over the FDA's budget.