Subcommittee on Agriculture, Rural Development, FDA and Related Agencies
Committee on Appropriations
U. S. House of Representatives
March 30, 2006
FDA Appropriations, FY 2007
Mr. Chairman, Members of the Subcommittee:
Consumers Union is the independent, non-profit publisher of Consumer Reports. We work on a wide range of consumer issues, many of which depend on an effective, efficient Food and Drug Administration that operates openly in the public interest.
We are concerned about many recent failures of the FDA to aggressively follow up on approved drugs and medical devices to determine their true long-range safety and effectiveness. To ensure that consumers are adequately protected, we urge Congress to adopt many of the suggestions in the Grassley-Dodd bills (S. 470/S. 930), including requiring the full, public registration of clinical trials so dangerous side effects are made known; creation of an independent safety center within FDA; and clear authority to require timely follow-up safety studies, accurate advertisements, and informative and clear drug labels.
Today, however, we specifically want to urge that the Subcommittee provide adequate resources for the FDA to reduce its backlog of generic drug approval applications and to begin the process of considering generic biologics.
Recent reports indicate that over 800 generic applications (about a three year backlog at current approval rates) are pending. Yet increasing the supply of generics and bringing competition to the biologics sector are key to helping American consumers—and Medicare and Medicaid taxpayers–save money and reduce inflation in the health-care sector.
The FDA is to be commended for seeking ways to lower the cost of new, important drug products, particularly those that may prolong life. But drugs only work if people can afford to take them. For too many Americans, particularly those who are uninsured or under-insured, drug prices are so high that they forgo filling prescriptions, cut dosages in half, or take other actions that are detrimental to long-term health.
The FDA also continues to delay in giving guidance to the U.S. industry on how to proceed in proving that a generic biologic can be basically as safe as the original product. The European Union’s Medicines Agency has approved the first generics for a biologic– the growth hormone medicine (Omnitrope), These types of drugs can cost $5,000 or more per month — in some cases they can cost $200,000 a year for treatment. Clearly, at some point in the patent process, consumers need the relief that generics and competition can provide. So far, the FDA has shown little leadership on this issue.
We believe that the FDA should be able to find more efficient ways to approve new, groundbreaking therapeutics at the same time it finds more effective ways to move generics into the marketplace. We hope that your Subcommittee will provide the resources — and the insistence — that the generic issues are addressed this year.
Disclosure statement: In 2004, Consumers Union received a $405,000 contract from HHS’s, NIH’s, National Library of Medicine to help explain and disseminate the work of the evidence-based medicine Drug Effectiveness Review Project.