A historical overview of FDA

As we know that the modern era of the FDA dates back to 1906 when the Pure Food and Drug Act was passed. This was an act that added regulatory function to the agency’s scientific mission, it prohibited interstate transport of unlawful food and drugs under penalty of seizure. But more importantly, it was fraught with shortcomings because it didn't regulate medical devices or cosmetics and it didn't give the FDA any explicit authority to inspect factories to prosecute false therapeutic claims and it didn't give any control over what drugs could be marketed. So really what came to happen shortly after in 1937 was defining.

In 1937 there was a company that tried to introduce an elixir of sulfanilamide and it was a flavorful oral dosage form and it was a new anti-infective that was supposed to be a wonder drug which was a disaster. The manufacturer used an untested solvent, chemical-related to antifreeze, and when FDA became aware of that issue, removed the product from shelves, Still, the preparation had caused over a hundred deaths including many children.

So that disaster reinvigorated a bill to replace the 1906 Pure Food and Drug Act which had been languishing in Congress for the past four or five years. At that point in 1938, President Roosevelt signed Food Drug and Cosmetic Act into law. Among many provisions, it required that firms had to prove FDA that a new drug was safe before it could be marketed and this was the birth of what we call the NBA or the new drug application.

This new law covered cosmetics and medical devices and authorized factory inspections and outlawed bogus therapeutic claims or drugs and so that someone could review these claims before marketing. And so, with that, it took one step closer to having drugs to be safe before they were marketed.

Then FDA went even one step closer to what where it is now. Which is a new drug law called the Kefauver-Harris Amendments. This was again an act that came on the heels of a disaster that was narrowly averted a solidified. In this case, it was an unapproved sedative but produced thousands of grossly to form newborns outside the United States.

This new law mandated efficacy as well as safety before the drug could be available to the general public. Required the FDA to evaluate the efficacy of all drugs and strict monitoring over drug trials. So, this is where the work that FDA currently does FDA comes from in terms of determining the efficacy and safety of drugs before going to market.

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