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7 Surprising Facts About the FDA

Written By Nancy LeBrun on December 1, 2020
  • stethoscope and medication pills on top of envelope with FDA text on top
    How much do you know about the FDA?
    The Food and Drug Administration (FDA) is mentioned almost daily in health news, but this government agency is more complex (and has a longer history) than many of us may realize. Here are a few interesting facts about the FDA, including how it started, the mission and responsibilities of the FDA, and some surprising statistics about the FDA today.
  • portrait of Lincoln Memorial
    1. The roots of the FDA started under President Abraham Lincoln.
    The precursor to the FDA was established in 1906 by the Pure Food and Drugs Act under the “Bureau of Chemistry,” which had been created by Abraham Lincoln. Its original mission was to stop the sale of falsely advertised or unsafe food and drugs. At the time, unregulated patent medicines were flourishing as the result of new marketing and advertising techniques that are still used today. The department got its current name, the Food and Drug Administration, in 1930 and now oversees more than $2.6 trillion worth of food, medical products, and tobacco.
  • Young Asian American female medical staff member review files in file cabinet
    2. The 2020 FDA budget was more than $3.4 billion.
    Out of the more than $3 billion budgeted for the FDA, about $2 billion is derived from user fees paid by manufacturers, with the remainder by government appropriation. User fees, which were instituted in 1992, speed up approvals, but some regard them as creating undue influence on the process by companies and politicians. The FDA uses about a third of the budget for drug regulation, while 10% is dedicated to oversight of medical devices and their radiation emissions. Biologics come in at about 7%. About 20% of the FDA budget goes to food safety, with the remainder spread across regulation of animal medicine, tobacco products, and administrative costs.
  • grouping of medicine vials
    3. The FDA has exponentially increased its approval of novel medications over the years.
    Until the ’50s, the FDA usually approved fewer than four NMEs (novel molecular entities) per year. The pace accelerated steadily and in some recent years, there have been as many as 50 or more new drugs approved. Today, there are more than 20,000 FDA-approved drugs currently on the market. Physicians now write about 3 billion prescriptions each year, and almost three-quarters of physician visits involve drug therapy. Nearly half of Americans have taken a prescription drug in the past 30 days, and about 85% of Americans over 60 take prescription drugs.
  • woman-in-grocery-store-looking-at-nutrition-label
    4. Some 3,000 state and local agencies use the FDA food code to supervise food safety.
    In the early 20th century, food began to be sold on the mass market for the first time and safety issues were rampant. The government began to step in and today, the FDA regulates more than three-quarters of the U.S. food supply. The exceptions are meat, poultry and some egg products, which are overseen by the Department of Agriculture. The FDA’s food code is used to oversee more than a million restaurants, grocery stores, vending machines, and cafeterias. Food suppliers must test and monitor their products according to FDA standards, and report sanitation and contamination problems.
  • woman reading pill bottle
    5. The FDA inspects pharmaceutical manufacturers overseas.
    When pharmaceuticals were largely manufactured in the U.S., the general rule was the FDA checked on the facilities every two years. Today, about 80% of pharmaceutical ingredient manufacturers operate in Asia (primarily China and India), mostly because of cheap labor costs. Since 2015, the FDA has conducted more foreign than domestic drug inspections, using “risk-based” criteria to formulate and prioritize oversight. The FDA rarely notifies the few domestic manufacturers of inspections, but it does notify foreign manufacturers due to complex logistics and high costs.
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    6. In 2016, Congress gave the FDA $500 million to speed up innovation and increase patient involvement.
    In December, 2016, Congress passed a law to fund the “21st Century Cures Innovation Account.” It was another step in accelerating the development of new medical products and medical countermeasures, and to increase the involvement of patients’ opinions and voices in the treatment pipeline. The law also eased some red tape for federally funded researchers and gave states funding to fight opioid abuse. Although it raised questions about whether some of the regulations might compromise public safety, it was reauthorized in 2019.
  • Man on laptop
    7. The FDA cracked down on more than 18,000 illegal online pharmacy websites—in one year.
    The FDA wages an ongoing battle against illegal online pharmacies selling questionable products, which proliferate around the world. In 2012, they shut down a staggering 18,000 websites, operated by 4,100 different entities. In 2018, they worked with 115 other countries and Interpol to identify 465 illicit pharmacy websites, resulting in 859 arrests. In 2020, the agency looked at 10,000 online pharmacies and determined that 97% of them were not in compliance with FDA regulations. The most sought-after drugs bought from illegal online pharmacies are for erectile dysfunction, birth control, and stomach disorders.
7 Surprising Facts About the FDA (Food and Drug Administration)

About The Author

Nancy LeBrun is an Emmy- and Peabody award-winning writer and producer who has been writing about health and wellness for more than five years. She is a member of the Association of Health Care Journalists and the American Society of Journalists and Authors.
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  3. The Food and Drug Administration
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    And How Often. Pharmaceutical Online. https://www.pharmaceuticalonline.com/doc/how-fda-and-mhra-decide-which-drug-facilities-to-inspect-and-how-often-0001
  8. The 21st Century Cures Act: What physicians need to know.
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  9. 21st Century Cures Act: MCM-Related Cures Provisions. U.S.
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  10. Illegal Online Pharmacies: How Endemic Are They? Pharma
    Technology Focus. https://pharma.nridigital.com/pharma_sep18/illegal_online_pharmacies_how_endemic_are_they
  11. FDA launches global operation to crack down on websites
    selling illegal, potentially dangerous drugs; including opioids. U.S. Food and
    Drug Administration.https://www.fda.gov/news-events/press-announcements/fda-launches-global-operation-crack-down-websites-selling-illegal-potentially-dangerous-drugs
  12. FDA Closes Down 18,000 Illegal Pharmacy Websites. MedBen. http://blog.medben.com/index.php/fda-closes-down-18-000-illegal-pharmacy?blog=2
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THIS TOOL DOES NOT PROVIDE MEDICAL ADVICE. It is intended for informational purposes only. It is not a substitute for professional medical advice, diagnosis or treatment. Never ignore professional medical advice in seeking treatment because of something you have read on the site. If you think you may have a medical emergency, immediately call your doctor or dial 911.