How a tragedy led to the prominence of FDA 

You have probably come across the name Food and Drug Administration (FDA) organization when news regarding COVID-19 started flooding our feeds. Every drug that enters the market must first be approved by the FDA in US. This is an agency that evaluates the safety and efficacy of food and drugs. The drug is critically examined before being mass-produced for consumers. This rigour ensures that only safe medications enter the market. However, these FDA policies were not always in place. It was only following an unprecedented incident that strict rules were established. Here is a look at the incident that gave birth to a life-saving authority organization. 

The sulphanilamide tragedy 
Sulphanilamide is used for treating streptococcal infections. Although it was being used safely as tablets and powder, in 1937, a demand for a liquid formulation arose. So, S.E. Massengill, a pharma company founded by Samuel Evans Massengill, enlisted their chief chemist Harold Cole Watkins to develop a liquid formulation of the drug. Watkins developed the formulation by dissolving the compound in diethylene glycol. The end product was called ‘sulphanilamide elixir’. The elixir was quickly approved and was distributed throughout the USA. This is because, back then, the FDA regulations did not require safety testing before signing off on a new drug. This claimed the lives of over 100 people. Many of the victims were children, with the youngest victim being merely six months old! But what was in the drug that made it lethal? Frances Oldham Kelsey, an FDA scientist, later discovered that mixing diethylene glycol with sulphanilamide powder made the product poisonous. To make matters worse, diethylene glycol poisoning had no known antidote or treatment at the time. 

As the death toll grew, people began to demand that the product be recalled. For the catastrophe he had caused, Massengill was ordered to appear in court. Unfortunately, due to the flimsy laws that existed back then, the court was unable to hold him accountable. He got away with just a fine. However, this incident jolted the authorities, prodding them to convene and devise strict rules with the safety of people as the top priority. 

FDA rises to prominence 
When the authorities learned how toxic sulphanilamide elixir was, they immediately sprung to action. Inspectors were dispatched to the headquarters of the manufacturing company to persuade them to issue a warning. The message stated, ‘Product may be dangerous to life. Return all stocks, our expense.’ The FDA went to great lengths to ensure that the products were recovered. With 239 FDA inspectors and chemists, they tracked down shipments and contacted doctors who had prescribed sulphanilamide elixir to their patients. The effort was joined by state and local health officials, newspapers, and radio stations. As a result, the Food, Drug and Cosmetic Act of 1938 came into effect, which gave the FDA more power and authority. This is still the basis for FDA regulation of food and drug products today. 

However, before the Federal Food, Drug and Cosmetic Act of 1938 came into being, the Food and Drugs Act of 1906 existed in the USA. It was under this law that the sulphanilamide elixir tragedy occurred, owing to manufacturer negligence and disregard for consumer safety.  

As the saying goes, ‘out of great adversity comes great opportunity,’ the sulphanilamide elixir tragedy sparked an act that has enabled all of us to purchase safe medications.