Just the Facts
FDA Facts
The FDA regulates roughly 25 percent of all consumer spending.
This includes foods, drugs, vaccines, medical devices, animal foods and drugs, blood, tissues, biotechnology, radiation-emitting products,
dietary supplements, cell therapies, and much more.FDA-regulated firms employ 1.5 million workers and represent 13 percent of manufacturing shipments in the United States.
FDA Funding
FDA funding has lagged behind appropriations for other public health agencies over the last two decades. For example:
In 1986, FDA's budget was $416.7 million – or 97 percent of the CDC's $429.4 million budget and 8 percent of NIH's $5.1 billion budget.
In 1996, FDA's budget was $865 million – or 39 percent of CDC's $2.2 billion budget and 8 percent of NIH's $10.2 billion budget.
In 2006, FDA's budget was $1.5 billion – or 28 percent of CDC's $5.2 billion budget and 5 percent of NIH's $27.7 billion budget.
History, Organization
2006 marks the centennial of the Pure Food and Drugs Act, signed by President Theodore Roosevelt.
The FDA was established in 1931, as part of the Department of Agriculture.
In 1940, the FDA was transferred to the Federal Security Agency and to the Department of Health, Education and Welfare (later renamed the Department of Health and Human Services) in 1953.
The FDA consists of the centers for Drug Evaluation and Research, Biologics Evaluation and Research, Food Safety and Applied Nutrition, Veterinary Medicine, Devices and Radiological Health, and Toxicological Research.
Q&A
What is the Coalition for a Stronger FDA?
We have come together as a broad and diverse coalition to call for a renewed public commitment for the Food and Drug Administration. The Coalition for a Stronger FDA is designed to unite a broad group of patient groups, nonprofit organizations, consumer advocates, public health organizations and innovative companies to work to increase FDA's appropriations. Supporting the Coalition for a Stronger FDA are a number of leading public health advocates - including former Health and Human Services Secretaries Tommy G. Thompson, Donna E. Shalala and Louis Sullivan, as well as William Hubbard, former FDA Senior Associate Commissioner for Policy and Planning and Legislation.
The coalition is designed to be a multi-year effort with the following goals: (1) making sure the FDA has sufficient resources to protect patients and consumers and (2) maintaining public confidence and trust in the FDA. The Coalition will build public support and work productively with the Administration and Congress. The Coalition welcomes and seeks to work in concert with the important ongoing efforts of individuals, companies, patient and consumer advocates and other groups to convince our policymakers of the importance of increasing the FDA's entire budget, including therapeutics, foods, cosmetics and medical products, to better serve American patients and consumers.
Why is the Coalition necessary?
The FDA is the key gatekeeper to the market for new life-enhancing and life-saving products for humans and animals and ensures the safety of our nation's food supply, regulating 25-cents of every consumer dollar. Yet, in recent years, the FDA has been forced to do more, with fewer and fewer resources.
While there have been increases in public funds for the FDA, the agency's funding has not kept pace with inflation, even as it's responsibilities have expanded:
FDA appropriations for screening and approval have dropped dramatically over the past five years as a percentage of total agency costs.
FDA funding has dramatically lagged behind that of other key public health agencies, such as the National Institutes of Health and the Centers for Disease Control and Prevention.
For example, a lack of sufficient public funding is causing an increased reliance on drug user fees. User fees now account for more than 59 percent of funding for FDA's human drug review, a whopping 700 percent increase since 1993 when the program was first implemented. This high rate of corporate support undermines public confidence in FDA's independence. Also, while user fees play a key role in providing multi-year predictability and stability for the FDA, they were never intended to replace annual federal appropriations.
It is critical that FDA resources keep pace with its responsibilities to oversee the safety of the food supply and to meet new challenges in nutrition, food security, the international regulatory environment and new technologies.
What are the Coalition's goals?
Quite simply, to increase funding for the FDA's budget to ensure it retains its role and reputation as the premier consumer protection agency in the world. In doing so, we will:
Ensure a strong public commitment to resources for FDA to fulfill its mission of assuring safety, efficacy, and security of the products it regulates.
Enhance public confidence in the FDA brand and safety and effectiveness of regulated products.
Ensure FDA does not become a bottleneck.
Move to more balanced funding for the agency.
How will the Coalition go about reaching its goals?
The FDA's ability to operate a modern, scientifically-based program must be strengthened. Recently, a significant and successful effort dramatically increased funding for scientific research at the National Institutes of Health. We need a similar effort to highlight the inadequacy of resources available at FDA to accomplish its mission of getting safe and effective therapies, foods, cosmetics and medical products into the hands of consumers and patients, and ensuring the safety and public confidence in those products while in the marketplace.
We plan to work directly with policymakers to advocate for increased appropriations. We are also planning a national campaign to educate the public and policymakers on the need for a stronger FDA. We plan to build awareness of the current deficiencies and new challenges, as we build a case for increased appropriations.
How will increasing appropriations for the FDA benefit consumers and patients?
The agency needs sufficient support to keep pace with new food and drug developments and new challenges, while providing patients and consumers with the life-saving and enhancing therapies and products they need:
Without sufficient resources at the FDA, new therapies for major diseases could be seriously slowed as the agency becomes a bottleneck for the approval of new products. Companies will face increased difficulty obtaining funding for innovative research and development without a clear review and approval timeline, jeopardizing U.S. leadership. Consumer confidence in food and drug safety will further erode.
The public cannot afford to let FDA's oversight of the safety and nutritional quality of the food supply fall behind. FDA must maintain global leadership in a science-based system of food regulation. The agency must also continue to address bioterrorism and needs sufficient resources for oversight and to develop countermeasures.
The federal government has built global-leading research base at NIH. We must now ensure FDA is prepared to deal with coming onslaught of new products.
It will help build support and confidence for an agency that 94 percent of the public views as very important (79 percent) or fairly important (15 percent) to the country, according to a Coalition for a Stronger FDA poll. This comes at a time when just 30 percent of the public says it has “a great deal of confidence” that the FDA ensures the products it regulates are safe and effective.
Who are the members of the Coalition for a Stronger FDA?
The Coalition for a Stronger FDA is made up of a broad group of patient groups, nonprofit organizations, consumer advocates, public health advocates and innovative companies. A full list of the member organizations can be found at www.fdacoalition.org.
Where can I find more information about the Coalition?
More information on the Coalition can be found at www.fdacoalition.org.
Latest News
Alzheimer's Growth Shows Need for Increased FDA Funding
Press Release
March 21, 2007