Food and Drug Administration

The FDA plays a pivotal role in the lives of Americans. The agency helps to speed innovations that make medicines and foods more effective, safer and more affordable, and plays a key role in monitoring, preparing for and responding to global public health challenges, such as antibiotic resistance and Ebola. Overall, the agency oversees a quarter of the products consumers purchase each year.  It is essential to ensure FDA receives the resources needed to fulfill its myriad responsibilities, including ensuring patients can access effective medical advances as quickly and safely as possible.

 

 
 

NOTE: Does not include supplemental funding from the American Recovery and Reinvestment Act of 2009 or the Ebola emergency supplemental funding in 2015.

Sources: FDA Reports, House Committee on Appropriations.

Americans Support Increased Funding for FDA

The Food and Drug Administration (FDA) is the agency responsible for the safety and effectiveness of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics and products that emit radiation. How important is it to increase funding for the FDA?

 

Source: A Research!America poll of U.S. adults conducted in partnership with Zogby Analytics in January 2016.

 

The FDA plays a significant role in everyday life in the United States

It oversees 75% of the US food supply.[1] It makes sure anything labeled with SPF offers effective sun protection[2], and that our cosmetics don’t contain unsafe levels of heavy metals.[3] On top of that, it regulates and ensure the safety of drugs we use, from ibuprofen for our head and stomach aches to life saving medications for rare diseases. American cupboards are filled with goods the FDA regulates. This far-reaching agency, however, has humble origins: it began as a chemistry laboratory in the Agricultural Division of the U.S. Patent Office.[4] Its original mission was modest as well; Congress tasked the laboratory staff in 1848 to chemically analyze “vegetable substances produced and used for the food of man and animals in the United States.”[5] By 1930, the year in which the Division was renamed the U.S. Food and Drug Administration, the mission of the agency had changed dramatically.[6]

Until the early 1900s, the American marketplace was virtually unregulated and not all products were what they claimed to be. For example, “honey was diluted with glucose syrup; olive oil was made with cottonseed; and ‘soothing syrups’ given to babies were laced with morphine.”[7] Certain individuals were concerned about how these products would affect the health of the American people. Harvey Wiley, for example, is often thought of as the first head of the FDA because of his tireless work to promote federal regulation of food and drugs. In 1902, he organized a group of volunteers known as the “Poison Squad” who tried out dubious products on themselves to demonstrate their negative effects.[7] Besides Wiley, the public was also starting to take an interest. In 1906 reporter Sinclair Upton published his novel The Jungle, which shed light on the unsanitary conditions of the American meatpacking industry at the time.[8]

The sustained efforts of Harvey Wiley, combined with a heightened public awareness of the importance of food and drug regulation in ensuring public health and safety, culminated in the passage of The Pure Food and Drug Act, also known as the Wiley Act, in 1906. The Act prevents “the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs or medicines, and liquors."[9] This landmark legislation set the stage for the FDA’s continued role in regulation.[8]

The FDA has made numerous regulatory decisions over time to protect the safety of American food and drugs. Twenty two years after the Pure Food and Drug Act was passed, scientists in London discovered penicillin, which ushered in the new age of antibiotics.[10]

The FDA began to test penicillin’s safety as part of the wartime development program in 1943 and approved the drug in September of that year.[11] As output increased, the FDA was given authority[12] to examine a sample of every batch of penicillin produced before it was released to the public or shipped overseas.

In 1960, FDA worker Frances Oldham Kelsey denied an application to sell thalidomide, originally marketed as a sleeping pill. She felt there was inadequate clinical evidence concerning the drug’s potential side effects. Her steadfastness won out, and the FDA limited the distribution of the drug in the U.S. Thalidomide was eventually linked to birth defects seen in thousands of infants abroad.[13]

Fast forward nearly thirty years to the height of the HIV and AIDS epidemic, when the FDA became the first public health agency in the world to approve an HIV drug —AZT.[14] Patient advocates pushed FDA to reexamine a regulatory paradigm that simply was not nimble enough to respond to the HIV/AIDS threat, and the drug was approved in just four months[15] underscoring the seriousness of the epidemic.[16] Though not a perfect solution and not prescribed as often today, the drug provided a much needed breakthrough in the seemingly unbreachable spread of the disease at the time.[17]

As the American people, and the world at large, turn to science for solutions to the problems we face, it’s critical that the FDA has the necessary resources to answer the call. It is simply impossible for patients and providers to determine the safety and effectiveness of each individual medical product that comes on the market and the public relies heavily on the FDA to be a vigilant gatekeeper. It’s essential that they be able to continue to play that role.

 

Sources:

[1] https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance   

[2] https://www.fda.gov/drugs/understanding-over-counter-medicines/sunscreen...

[3] https://www.fda.gov/cosmetics/potential-contaminants-cosmetics/fdas-test...

[4] https://www.fda.gov/about-fda/history-fdas-fight-consumer-protection-and...

[5] https://www.fda.gov/about-fda/history-fdas-internal-organization/fda-lea...

[6] https://www.fda.gov/about-fda/history-fdas-fight-consumer-protection-and...

[7] https://www.fda.gov/about-fda/fda-leadership-1907-today/harvey-w-wiley

[8] https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/part-i-190...

[9] http://library.clerk.house.gov/reference-files/PPL_059_384_FoodDrugCosmeticAct.pdf

[10] https://www.acs.org/content/acs/en/education/whatischemistry/landmarks/f...'s%20Hospital%20in%20London.

[11] https://www.fda.gov/about-fda/virtual-exhibits-fda-history/brief-history...

[12] https://jamanetwork.com/journals/jama/article-abstract/275427

[13] https://www.fda.gov/about-fda/virtual-exhibits-fda-history/frances-oldham-kelsey-medical-reviewer-famous-averting-public-health-tragedy

[14] https://www.niaid.nih.gov/diseases-conditions/antiretroviral-drug-develo...

[15] https://aidsinfo.nih.gov/news/274/approval-of-azt

[16] https://www.pbs.org/wgbh/pages/frontline/aids/interviews/fauci.html

[17] https://www.thelancet.com/action/showPdf?pii=S2352-3018%2817%2930066-8

 

Policy Contacts

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We have health challenges in this country that science will provide answers for if given the chance and we haven't given science that opportunity
Mary Woolley, President and CEO, Research!America