Tag Archives: Pharmaceutical Regulation

This is a Very Bad Idea

I was stunned when I saw this headline in the New York Times last week: “Court sides against FDA in ‘off-label’ drug promotion case.” In case you missed it, here is the lede:

The maker of a prescription fish-oil pill won an early victory Friday against the Food and Drug Administration over its right to publicize unapproved uses of its drug.

The gist of the story is that the pharmaceutical company successfully claimed that restricting its ability to promote off-label use with (in the words of the court) “truthful and non-misleading information” violated its First Amendment right to free speech.

Let me be clear here. I am all for maintaining the longstanding prerogative that physicians and other licensed prescribers have to prescribe approved medications for unapproved indications.  That’s not what this is about.

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