As Dr. Simon pointed out in his first video, it is important to understand the history of the FDA when learning about regulation. One event I would like to highlight is the thalidomide scandal of 1962. Thalidomide was a sedative prescribed to many Europeans, many of whom were pregnant. As a result of the drug, thousands of children were either born dead or deformed. The children that were born deformed had phocomelia, or seal limbs. The chemical reason why this occurred was that the drug became racemic when sent to patients and contained both S and R enantiomers of the compound. The S enantiomer was tetragenic. It sparked several debates, including contraception, abortion, and, most notably, regulation.

Now I specifically said thousands of Europeans were affected. What about Americans? Well, there were only a few dozen cases reported of phocomelia as a result of thalidomide use. So your next question may be, why wasn’t America affected as severely? Well, you can thank Frances Kelsey for helping to avoid the same disaster in America. Dr. Kelsey was working for the FDA at the time she received an NDA for thalidomide. She was unconvinced of the safety and efficacy of the drug and required more testing. Other officials at the FDA neglected the potential harm of thalidomide, so if not for her, we would have shared with Europe in one of the biggest drug catastrophes in recent history. After her intervention, she was awarded the Distinguished Civilian Service Medal in 1962. Because of her efforts, there was a huge push in Congress for further regulation. In 1962, John F. Kennedy signed the Kefauver-Harris Act, a law that strengthened the powers of the FDA to evaluate the efficacy and safety of drugs as well as requiring stricter guidelines for drug advertising.

So my question to you is, knowing all of this, what do you think made the Thalidomide disaster in the 1960’s so crucial in strengthening the regulating powers of the FDA? How do you think the FDA would look like today if the Thalidomide disaster never happened?