The FDA arose after the tragedy caused by the first antibacterial drug, sulfanilamid. In December 1932 of the year Gerhard Domagk, a chemist working for the German chemical giant IC Farben, Prontosil azo dye patented. This substance did not cause any adverse effects in cats or rabbits, but tests on infected mice produced a rather unexpected result. Twelve mice infected with streptococci should have died after two days. After taking Prontosil, however, the animals recovered. Tests at a local hospital confirmed the substance's effectiveness, and Domagk even applied it, to cure his daughter of the infection.
The operation of Prontosil was based on this, that it was causing the body to produce sulfanilamide. It is this substance, not the dye itself, had antibacterial properties. Prontosil could not be patented as a therapeutic, because the antibacterial properties of sulfanilamide were already known in 1919 year. We know now, how this substance works: blocks the enzyme that bacteria need to produce folic acid, just as necessary for microorganisms, as well as man. However, people get the folic acid they need from the food they eat, the bacterium must produce it itself. Giving a dose of sulfanilamide to a person with a bacterial infection, the multiplication of microorganisms is inhibited until the human defense system produces antibodies capable of killing bacteria.
Sulfanilamide was marketed in 1936 year. It was the first time that doctors had effective tools to treat such ailments, like bacterial pneumonia in children. In the UK, the drug was known as M.&B, from its producer May&Baker. It was administered in the form of tablets. Tablets are not the most convenient way to give drugs to children, lotions are better. In this respect, however, sulfanilamide posed problems. The substance did not dissolve in popular solvents used in the preparation of drugs at that time, that is, in water or alcohol. However, it dissolved in ethylene glycol, the type of alcohol normally used as anti-freeze. The solution of sulfanilamide in glycol has come to be known as an "elixir."” and it was sold in this form.
W 1937 During the year, doctors began reporting to the American Medical Association of unexpected deaths in patients treated with sulfanilamide. The drug was withdrawn from use, before it happened, died 107 people, mostly children. Research by Francis Kelsey has shown, that it was not guilty of death, but the solvent. The tragedy caused by the sulfanilamide elixir led to the enactment of 1938 Food years, Drug and Cosmetic Act. There was a record in it, that from now on, any substance approved for sale must be approved by the FDA. This organization justified the reason for its existence, when in 20 years after her appointment, her lengthy procedures prevented the thalidomide tragedy in the United States. Of course, pharmaceutical companies carry out very strict tests themselves, before submitting their product for FDA approval. Nevertheless, a fourth of the proposed drugs fail in the first attempt, in the so-called Phase I clinical trials, when research is carried out on a group to 100 people. Another quarter is lost in phase two, covering several hundred people, and another one in the third (covering thousands of respondents). Only one in four new drugs submitted to the FDA gains approval and hits the market.