When you turn on the television news these days, there's a good chance you'll hear two pundits having a heated debate about the merits of government regulation. Some feel it's costly and hampers progress while others feel it's necessary to keep businesses honest. As a regulatory agency, the FDA is certainly no stranger to this controversy. A quick look back at the agency's history shows that both sides of the regulation debate have some valid points.
One instance when critics felt FDA regulations slowed progress was during the AIDS epidemic of the 1980s. Little was known about the disease, and for many it was a death sentence. Activists felt the FDA was dragging its feet through the approval process for promising new drugs. The conflict came to a head Oct. 11, 1988, when 1,000 protesters managed to close down the agency's headquarters in Maryland, some holding posters that read, "Time isn't the only thing the FDA is killing" [source: Crimp].
Others think FDA regulation doesn't go far enough. These critics point to cases like that of Vioxx, a painkiller approved by the agency in 1999. When a 2000 study showed the drug might pose a significant risk for heart attack when compared to a similar painkiller, Vioxx's manufacturer, Merck, shrugged it off. The other drug simply had a highly beneficial effect on the heart, they reasoned. The FDA accepted the argument, and Vioxx remained on the market until 2004, when Merck pulled it amid mounting criticism. By this time, according to one study, Vioxx had caused between 88,000 and 140,000 heart attacks [source: Bhattacharya and Berenson et al.].
Still, the FDA has had some undeniable successes, like its refusal to license the sleeping pill thalidomide in the United States. Developed in Germany, scientists initially viewed the drug as exceedingly safe, approving it for over-the-counter use in most European countries by 1956. In 1961, however, scientists discovered a link between thalidomide and children born with malformed limbs. While such birth defects affected 10,000 children worldwide, the United States was largely spared thanks in large part to resistance from the FDA and, specifically, its drug examiner, Frances Oldham Kelsey [source: Science Museum].
Author's Note: How the FDA Works
When writing about government agencies like the FDA, things can get dry pretty fast. But hidden beneath snooze-worthy policies, regulations and organizational charts are truly fascinating historical events that influenced the agency's development in one way or another. There were so many, in fact, that I couldn't mention them all in the article. There was the story of elixir of sulfanilamide, which killed 107 people, mostly children, and led to the passage of the Federal Food, Drug and Cosmetic Act of 1938. Or the mysterious case of Tylenol capsules laced with cyanide, which led to tamper-resistant packing regulations in 1982. Bureaucracy: It's more interesting than you think!
More Great Links
- Berenson, Alex et al. "Despite Warnings, Drug Giant Took Long Path to Vioxx Recall." The New York Times. Nov. 14, 2004. (March 26, 2015) http://www.nytimes.com/2004/11/14/business/14merck.html?pagewanted=all
- Bhattacharya, Shaoni. "Up to 140,000 heart attacks linked to Vioxx." Jan. 25, 2005. (March 26, 2015) http://www.newscientist.com/article/dn6918-up-to-140000-heart-attacks-linked-to-vioxx.html
- Crimp, Douglas. "Before Occupy: How AIDS Activists Seized Control of the FDA in 1988." The Atlantic. Dec. 6, 2011. (March 26, 2015) http://www.theatlantic.com/health/archive/2011/12/before-occupy-how-aids-activists-seized-control-of-the-fda-in-1988/249302/
- Janssen, Wallace. "The Story of the Laws Behind the Labels." FDA Consumer. June 1981. http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm056044.htm
- McQueeney, Kerry. "Cocaine for Toothache, Morphine for Your Child's Cough: The Bizarre 'Safe Cures' of 19th Century that 'Work like Magic.'" Daily Mail. Sept. 4, 2012. (March 24, 2015) http://www.dailymail.co.uk/news/article-2198086/Victorian-adverts-health-remedies-laden-cocaine-morphine-alcohol.html
- Science Museum. "Thalidomide." (March 26, 2015) http://www.sciencemuseum.org.uk/broughttolife/themes/controversies/thalidomide.aspx
- Sinclair, Upton. "The Jungle: Centennial Edition." Modern Library Paperbacks. June 6, 2006. http://www.amazon.com/Jungle-Modern-Library-Paperbacks/dp/0812976231/
- Swann, John P. "FDA's Origin." U.S. Food and Drug Administration. 1998. http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm124403.htm
- U.S. Department of Health & Human Services. "About HHS." Oct. 6, 2014. (March 23, 2015) http://www.hhs.gov/about/
- U.S. Department of Health & Human Services. "Fiscal Year 2014 Budget in Brief: Strengthening Health and Opportunity for All Americans." March 12, 2014. (March 23, 2015) http://www.hhs.gov/budget/fy2014/fy-2014-budget-in-brief.pdf
- U.S. Food and Drug Administration. "About the Office of Regulatory Affairs." March 4, 2015. (March 31, 2015) http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/default.htm
- U.S. Food and Drug Administration. "About the Office of the Commissioner." Feb. 25, 2015. (March 25, 2015) http://www.fda.gov/AboutFDA/CentersOffices/OC/default.htm
- U.S. Food and Drug Administration. "Career Descriptions." Oct. 19, 2011. (March 31, 2015) http://www.fda.gov/AboutFDA/WorkingatFDA/CareerDescriptions/default.htm
- U.S. Food and Drug Administration. "FDA Organization." Feb. 25, 2015. (March 26, 2015) http://www.fda.gov/AboutFDA/CentersOffices/default.htm
- U.S. Food and Drug Administration. "FY 2014 Operating Plan Narrative." (March 24, 2015) http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM388299.pdf
- U.S. Food and Drug Administration. "Harvey W. Wiley." January - February 2006. (March 25, 2015) http://www.fda.gov/AboutFDA/WhatWeDo/History/CentennialofFDA/HarveyW.Wiley/
- U.S. Food and Drug Administration. "History." March 23, 2015. (March 24, 2015) http://www.fda.gov/AboutFDA/WhatWeDo/History/
- U.S. Food and Drug Administration. "Is it Really FDA Approved?" Sept. 30, 2008. (March 27, 2015) http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm
- U.S. Food and Drug Administration. "Legislation." March 11, 2015. (March 26, 2015) http://www.fda.gov/RegulatoryInformation/Legislation/default.htm
- U.S. Food and Drug Administration. "ORA Overview." Aug. 12, 2014. (March 31, 2015) http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ucm409371.htm
- U.S. Food and Drug Administration. "Significant Dates in U.S. Food and Drug Law History." Dec. 19, 2014. (March 26, 2015) http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm128305.htm
- U.S. Food and Drug Administration. "What Does FDA Inspect?" Nov. 18, 2014. (March 26, 2015) http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194888.htm
- U.S. Food and Drug Administration. "What Does FDA Regulate?" Nov. 18, 2014. (March 25, 2015) http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm
- U.S. Food and Drug Administration. "What is the Difference Between the Federal Food, Drug and Cosmetic Act, FDA Regulations, and FDA Guidance?" Nov. 18, 2014. (March 26, 2015) http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194909.htm
- U.S. Food and Drug Administration. "When and Why Was FDA Formed?" Nov. 18, 2014. (March 23, 2015) http://www.fda.gov/aboutfda/transparency/basics/ucm214403.htm
- U.S. National Archives and Records Administration. "Records of the Food and Drug Administration." (March 25, 2015) http://www.archives.gov/research/guide-fed-records/groups/088.html