The Birth of the FDA

In the 1930s, a pharmaceutical company named S. E. Massengill produced a medication that proved helpful in

These innocent-looking toothache drops make no bones about their chief ingredient: cocaine!

fighting bacterial infections. The medication was called "sulfanilamide." Sulfanilamide, in pill form, tasted terrible and was difficult to swallow, so the manufacturer decided to produce the same medication in liquid form. In 1937, Massengill developed a liquid sulfanilamide solution, added some pink food coloring and cherry flavoring, and began selling the product to the public. Because of its bright color and appealing taste, the new medicine, now called Elixir Sulfanilamide, was especially useful for children. Parents bought the tasty solution for sons and daughters who had earaches, chest colds, sore throats, high fevers—anything caused by a bacterial infection. The pill form worked well; surely the liquid form of the same medication would work well, too.

Unfortunately, children treated with the new liquid didn't get well. They died. In all, 107 people died (mostly children) from taking Elixir Sulfanilamide. Why? The chemists who developed the elixir knew that sulfanilamide could not be dissolved in water so they used a different, untested liquid in which to dissolve the helpful drug. That liquid, which became the base for the new liquid medication, was called diethylene glycol. It was much like what we use in automobile antifreeze today. The liquid used to carry a beneficial drug to bacterial infections poisoned those who took it.

What happened when so many died? The chemist who developed Elixir Sulfanilamide was so distraught over the tragic deaths his medicine caused that he committed suicide. Massengill, the company who made and marketed the pink liquid, was fined $26,100 (the maximum fine legally allowed at that time), but not otherwise held liable. More important, an outraged public cried out for action, which resulted in the passage of a new law,

Sufanilamide

Elixir Sulfanilamide caused the death of 107 people. It contained an ingredient similar to antifreeze.

called the Food, Drug and Cosmetic Act of 1938. This new legislation required drug companies to prove that a new drug was safe before they could sell the drug to the public. For the first time in history, medicines would have to be tested and proved safe before release. Who would examine the proof? A government agency called the United States Food and Drug Administration, what today we refer to as the FDA.

Continue reading here: Drug Approval in Canada

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