Inflection Point: Government FDA Bureaucrat who Saved Many Lives

Poster honoring Frances Oldham KelseyI used to teach courses in Government Regulation of Business and the thalidomide/FDA story was a great case study.

So, I was interested and saddened to see the recent death of Dr. Frances Oldham Kelsey, an amazing woman.

Kelsey was the chief medical officer at the FDA in the 1950s and 1960s, and her skepticism about thalidomide saved American lives. In the bigger picture, it is a tale of a government bureaucrat doing the right thing, and really a great thing for our society.

As many people know, thalidomide was a drug aimed at reducing morning sickness in pregnant women, but in the late 1950s and early 1960s, it became associated with birth defects in children in Europe.  Dr. Kelsey examined this data carefully, and forced drug firms in the US to provide more information, before allowing FDA approvals to move forward.  When the evidence was clearer, it was banned, and, thus the US avoided the thalidomide birth defects problem.

And, in 1962, largely because of this case, Congress passed a law that required the FDA to examine and test both the effectiveness of new drugs, and their safety.   The full history of the FDA includes responses to societal changes – Sinclair Lewis’ 1907 book The Jungle and food safety, leading to a food inspection role for the the Department of Agriculture,  the creation of the FDA in the 1930s to focus on drug effectiveness (responding to the various “elixirs” that were then popular), followed by this 1962 safety focus on “side effects.”

As of 2015, it is worth noting that, as in all things related to government regulation, some balance is critical.  The FDA now requires firms to provide consumers with a lot of information about side-effects. So much so that current TV (and magazine) advertisements can be amazing, with the explicit discussion of so many (sometimes embarrassing or scary) side effects, that my kids often ask “why would anyone take that drug?”  Hopefully because it is effective and the side effects are manageable.

 



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