Throwbacks to the 1980s... and 50s?

I was in the car yesterday when I heard this intriguing tidbit on the radio:

FDA approves Diclegis for pregnant women experiencing nausea and vomiting

 

Okay, maybe not so intriguing, unless you happen to be suffering from acute morning sickness, which I am not. But as the mastermind behind the FDA Monitor, I felt compelled to check it out. And what I found was actually quite interesting.

You wouldn't pick this up from the FDA article, but Diclegis, the newly approved nausea medicine, is actually just a re-branded version of Bendectin, a nausea medication that was pulled from the market in 1983.


In other words, women were unnecessarily subjected to THIRTY YEARS of discomfort and illness. As the drug company now producing Diclegis proudly states, it is the only FDA approved medicine for morning sickness.

And it was originally approved in 1956.

So what happened? As this New York Times article from 1983 explains, a "shadow of doubt" wiped out Bendectin. Fear fostered by media and overly litigious lawyers made it impossible for the drug company producing Bendectin to defend itself in court and keep Bendectin on the market. So not only were they forced to undergo the complex, exacting, expensive procedure of gaining FDA approval, the approval did not protect them in the marketplace.

But now we have it back again. Perhaps the shadow of doubt was erased over the last thirty years. But it is clear that the FDA did not protect women from morning sickness for the past thirty years. Do lawsuits perhaps protect consumers more comprehensively than the FDA? In any case, why do we need both? I am curious to hear your thoughts on the issue.

They thought the 80s were behind them, too:)