The FDA. We hear that acronym in the news more now than ever before but what is the FDA, really? Where does its power come from and what does it do? First, FDA stands for the Food and Drug Administration and is an agency of the United States government. It gets its power from Congress and is the result of a collection of laws that dictate the parameters of its power. You might know the most common one, the Federal Food, Drug and Cosmetic Act. It is one of the oldest of the dozen or so laws and acts grounding the FDA. It’s name has changed over the years to reflect its role and expertise though “FDA” has stuck for almost the last century.
Year Designation and Location Statute
1839 Patent Office, Department of State 5 Stat. 353, 354 (1839)
1849 Chemical Laboratory of the Agr, Dpt of the Interior 9 Stat. 395 (1849)
1862 Chemical Division, Department of Agriculture 12 Stat. 387 (1862)
1889 Chemical Division, U S Department of Agriculture 25 Stat. 659 (1889)
1890 Division of Chemistry, USDA 26 Stat. 282, 283
1901 Bureau of Chemistry, USDA 31 Stat. 922, 930 (1901)
1927 Food and Drug Insecticide Administration, USDA 44 Stat. 976, 1002 (1927)
1930 Food and Drug Administration, USDA 46 Stat. 392, 422 (1930)
1940 FDA, Federal Security Agency 54 Stat. 1234, 1237 (1940)
1953 FDA, Department of Health, Education, and Welfare 67 Stat. 631, 632 (1953)
1979 FDA, Department of Health and Human Services 93 Stat. 668, 695 (1979)
With an annual budget of around $6 billion, it’s important to understand as much as we can about this regulatory organization. The Administration is led by a commissioner that is appointed by the president and employs around 18 thousand people around the country. It’s important to note that there is a pretty significant gap in the FDA’s responsibilities as the USDA handles most meat, poultry and eggs regulation. The Food Safety and Inspection service and the National Institute of Food and Agriculture are both separate entities. Also, as we’ve touched on in previous articles, things like food waste and pesticides are actually handled by the EPA. It’s also important to note that most food labeling regulation is outside of its purview. Some labeling is overseen by the USDA but the FDA basically just requires that food has nutritional information on its label. The accuracy of that information is not policed by them.
A big part of understanding the conversation today about the FDA and if they are being effective in their role in the current pandemic is the question of funding. The FDA is funded in part by taxpayer money and in part but what is called user fees. Basically, manufacturers pay fees when they submit an application for their drug to be reviewed and then they pay an annual fee based on the number of drugs they have approved and in the marketplace. While about half of the FDA budget comes from user fees, more than 60% of the human drug related budget comes from user fees. Put simply, more approvals equals more money for the FDA. This might strike you as odd because it seems like a conflict of interest for the regulatory body to be funded by giving their approval to companies within the industry it is meant to regulate. Exactly. Here in lies one of the biggest pitfalls of a strong belief in the mission of the FDA. While this doesn’t automatically mean that the FDA is chasing their payday instead of prioritizing the safety of the American public, it does give one something to think about. It might also explain why drugs such as Nuplazid, a treatment for Parkinson's that lead to more deaths in the test group than the control group which received zero treatment, are still allowed to hit the market. It is one explanation but I’m sure there are others. We, the American people, are just still waiting to hear them.
Resources:
https://www.propublica.org/article/fda-repays-industry-by-rushing-risky-drugs-to-market
https://www.cfr.org/backgrounder/what-fdas-role-public-health
https://today.uconn.edu/2021/05/why-is-the-fda-funded-in-part-by-the-companies-it-regulates-2/