Pandora’s Box is Opening

Pharma can’t be prosecuted for off-label marketing, court rules

This just in from FiercePharma.

The upshot: “The government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug and Cosmetics Act] for speech promoting the lawful, off-label use of an FDA-approved drug,” – U.S. Circuit Judge Denny Chin

While I’m a firm believer in the 1st amendment, I’m not sure it should usurp the role of the FDA to insure the safety and efficacy of regulated drug products and devices in the US. There has to be some checks and balances here, otherwise corporate greed will insure that drugs with very serious side effects will end up in the hands of people that may not need them, or may be harmed by them, all in the name of making a buck.

I think this ultimately ends up in the Supreme Court.