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see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight."
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A woman wrote to U.S. President
Roosevelt and described the death of her daughter: "The first time I ever had occasion to call in a doctor for and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can
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Congress responded to public outrage by passing the 1938 Food, Drug, and
Cosmetic Act, which required companies to perform animal safety tests on their proposed new drugs and submit the data to the FDA before being allowed to market their products. The Massengill Company paid a minimum fine under
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The owner of the company, when pressed to admit some measure of culpability, infamously answered, "We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part." Watkins, the chemist,
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occurred in 1930 and studies had been published in medical journals stating DEG could cause kidney damage or failure, its toxicity was not widely known prior to the incident.) Watkins simply mixed raspberry flavoring into the powdered drug and then dissolved the mixture in DEG.
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of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control in the United States of
America for drugs until Congress enacted the 1938 Food, Drug, and Cosmetic Act in response to the elixir sulfanilamide poisonings.
86:, and called the preparation "Elixir Sulfanilamide". DEG is poisonous to humans and other mammals, but Harold Watkins, the company's chief pharmacist and chemist, was not aware of this. (Although the first case of a fatality from the related
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in the United States in 1937. It is believed to have killed more than 100 people. The public outcry caused by this incident and other similar disasters led to the passing of the 1938
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was not required by law, and
Massengill performed none; there were no regulations at the time requiring premarket safety testing of drugs.
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The company started selling and distributing the medication in
September 1937. By October 11, the
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assisted on a research project that verified that the DEG solvent was responsible for the fatal
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provisions of the 1906 Pure Food and Drugs Act, which prohibited labeling the preparation an "
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was notified, and an extensive search was conducted to recover the distributed medicine.
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Reputation and Power: Organizational Image and
Pharmaceutical Regulation at the FDA
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The clinical toxicology laboratory: contemporary practice of poisoning evaluation
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228:"Wallace Reveals How Federal Agents Traced Elixir to Halt Fatalities"
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received a report of several deaths caused by the medication. The
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Antibiotic preparation responsible for a mass poisoning in 1937
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Human subject research legislation in the United States
114:. At least 100 deaths were blamed on the medication.
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154:1985 Austrian diethylene glycol wine scandal
285:. Princeton: Princeton University Press.
376:United States federal health legislation
149:List of medicine contamination incidents
118:committed suicide while awaiting trial.
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356:Medical scandals in the United States
346:Health disasters in the United States
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42:, which significantly increased the
40:Federal Food, Drug, and Cosmetic Act
381:1937 disasters in the United States
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178:Ballentine, Carol (June 1981).
23:Bottles of elixir sulfanilamide
260:. Washington, DC: AACC Press.
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46:'s powers to regulate drugs.
341:Food and Drug Administration
309:Mihm, Stephen (2007-08-26).
104:Food and Drug Administration
100:American Medical Association
44:Food and Drug Administration
30:was an improperly prepared
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281:Carpenter, Daniel (2010).
254:Shaw, Leslie M. (2001).
180:"Sulfanilamide Disaster"
68:S. E. Massengill Company
371:Sulfonamide antibiotics
201:"Medicine: Post-Mortem"
361:Pharmaceuticals policy
56:Pure Food and Drug Act
32:sulfonamide antibiotic
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386:1937 health disasters
187:FDA Consumer Magazine
130:" if it contained no
108:Frances Oldham Kelsey
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28:Elixir sulfanilamide
313:. The Boston Globe.
236:. November 26, 1937
209:. December 20, 1937
233:The New York Times
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311:"A tragic lesson"
292:978-0-691-14180-0
76:diethylene glycol
34:that caused mass
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88:ethylene glycol
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331:Adulteration
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238:. Retrieved
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60:Harrison Act
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336:Drug safety
325:Categories
240:2009-07-20
213:2009-07-19
160:References
84:excipient
66:In 1937,
36:poisoning
138:See also
366:Poisons
132:ethanol
80:solvent
50:History
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128:elixir
74:using
183:(PDF)
287:ISBN
262:ISBN
206:Time
82:or
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