Durk Pearson & Sandy Shaw’s®
Life Extension NewsTM
Volume 16 No. 5 • May 2013

Recent Court Decisions Rule Commercial Speech
on Off-Label Use of Drugs is Protected by the First Amendment

The Jan. 10, 2013 issue of The New England Journal of Medicine contained an article reviewing four recent Court decisions supporting the rights (under the First Amendment) of pharmaceutical companies to promote off-label uses of drugs approved by the FDA for a different purpose. Recognizing that the FDA’s authority does not extend to the practice of medicine, the article notes that the agency cannot prohibit physicians from prescribing approved drugs for non-approved uses.

It is widely recognized, though this was not discussed in the article, that a large percentage of drugs prescribed for the treatment of cancer (as an example) are for off-label uses (not the uses the FDA approved them for) and that this constitutes an important part of modern medicine, extending or saving large numbers of lives.

One of the main arguments made against the promotion of off-label uses of drugs approved by the FDA for a different purpose is that without being able to silence pharmaceutical companies from promoting off-label uses, manufacturers can seek approval only for certain limited uses of drugs, then promote that same drug for off-label uses, effectively circumventing FDA’s new drug requirements. In fact, the trial court in Caronia (a case discussed in the article) upheld the constitutionality of the FDA’s regulations prohibiting off-label uses of FDA approved drugs because it (the court) could not identify a less restrictive manner in which to prohibit pharmaceutical companies from circumventing the FDA approval process.

We note that just because the court could not think of any less restrictive manner (than an outright ban on First Amendment protected speech) to prevent the circumvention of the FDA’s approval process is hardly a legitimate basis for throwing out the First Amendment. (It certainly suggests that something is wrong, e.g., unconstitutional, with the FDA’s approval process if it cannot accommodate the First Amendment’s protections of speech and press.) The Constitution does have a procedure for amendment and the proper way to eliminate the First Amendment’s protection of some area of speech would be to pass an amendment to do that. Otherwise, it is just a court deciding on its own that it didn’t approve of the consequences of exercising one’s First Amendment’s rights and declaring the First Amendment doesn’t protect that speech.

The article noted that “[i]n overturning Caronia’s conviction, the three judge panel of the Second Circuit agreed that the FDA regulations were overly broad, specifically noting that nothing Caronia did constituted conspiracy to put a false or misleading or deficient label on a drug product. The court appeared particularly persuaded by the argument that the FDA regulations allow unfettered prescribing of approved drugs for off-label uses but then, through the off-label restrictions, refuse to allow the free flow of information that would result in a full vetting of the uses, limitations, and side effects of the drug. The Second Circuit held that such restrictions violate the principles of the First Amendment.”

The article concludes: “The question now is whether a host of other state and federal regulations can withstand such First Amendment scrutiny.” Thank goodness the First Amendment protection of speech and press still appears to have some teeth!

This case is a logical extension of our First Amendment arguments in Pearson v. Shalala.


  • Marcia M. Boumil, J.D., LL.M. Off-label marketing and the First Amendment. N Engl J Med. 368(2):103-5 (2013).

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