It might not mean a thing …

… but then again it might.

Once upon a time, we had no regulation of drugs. The pharma industry has been around, reps and all, for at least 150 years and of course medicine as a discipline is thousands of years old, and the FDA just celebrated its centennial. In 1906, the FDA and former incarnations were created to insure the safety of foods, drugs, and cosmetics. Over the years it has been given more authority and responsibility, and in the 1960’s it was charged with making sure that new pharmaceuticals are safe and effective.

The DC Court of Appeals decision questions the “and effective” part in a rather strongly worded opinion.

I think this case now has the attention of a lot of people.


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