As the nation's foremost consumer protection agency, the U.S. Food and Drug Administration, (FDA) serves a critical role, safeguarding not only prescription and non-prescription drugs, but also medical devices, dietary supplements, animal drugs and feeds, and the nation's food supply.
The FDA has proven its effectiveness, when provided with adequate resources. For example, before Congress passed the 1992 Prescription Drug User Fee Act it took an average of 30 months to review new medications. The Act allows FDA to collect fees from companies that produce certain human drug and biological products. After the Act was implemented and additional funds were obtained, the FDA was able to streamline its systems and hire more skilled employees, in turn, reducing the average review time for an innovative new drug to six months. User fees have had many benefits however, FDA programs that cannot be funded through user fees have suffered drastic cutbacks.
Greater Responsibilities, Fewer Resources
The FDA regulates an astounding 25 percent of all U.S. consumer spending. Yet in spite of this enormous responsibility, in recent years the FDA has had to function with fewer resources-yet at the same time has been expected to do more.
Additionally, FDA funding has not kept pace with other key public health agencies such as the National Institutes of Health(NIH) and the Centers for Disease Control and Prevention (CDC). In 1986, for example, the FDA's budget was $416.7 million, or 97 percent of the CDC's $429.4 million budget. Contrast that with the current 2006 FDA budget of $1.5 billion, which is just 28 percent of the CDC's $5.2 billion budget.
Research Advances Will Impact FDA's Effectiveness
Scientific advances achieved within the last five years, such as the sequencing of the human genome, have raised widespread hope for a novel approach to the prevention and treatment of disease. Visions of innovative diagnostics, biologics and new technologies to revolutionize pharmaceutical therapies promise significant payoffs in human health. Although a positive development, the impact on the FDA-and the public-could be catastrophic, as the under-funded agency works to review the onslaught of new cutting-edge treatments that is expected.
If FDA funding does not increase, the system will bottleneck and companies dedicated to finding new ways to treat disease will not be able to deliver therapies quickly enough to the people who need them; they will also face increased difficulty in the future obtaining new research funds, as developers will be hesitant to dedicate dollars to research without an efficient and predictable approval process at the FDA.
Advocating for Increased Funding
The Alliance for Aging Research is a member of two coalitions that have been formed recently to advocate for increased funding for FDA. Both the FDA Alliance and the Coalition for a Stronger FDA share the goal of increasing federal funding for the FDA to ensure access to life-saving treatments and therapies now and in the future.
Lives Can Be Improved and Saved
The FDA's public health responsibilities are formidable, and it must have a budget sufficient enough to support scientists and other professionals who have the knowledge and expertise needed to expertly evaluate new therapies, assessing their risks and benefits.
With proper funding, the FDA will be able to modernize and adapt to the changing 21st century drug and device development environment, saving and improving countless lives in the process. Without sufficient funding, access to these life-saving resources could be slowed considerably as the FDA struggles to carefully review and approve them.
