Maybe not (NEJM 2013; 368: 103-05).
While the FDA is responsible for overseeing the safety of pharmaceuticals and veracity of marketing, its authority does not extend to the practice of medicine. This enables the widespread practice of using medications for “off-label” purposes. Physicians can use approved drugs for nonapproved uses. FDA regulations have restrained marketing of off-label uses of prescription medications by pharmaceutical representatives.
However, a recent appellate ruling in United States v. Caronia has stated “the government cannot prosecute pharmaceutical manufacturers…for speech promoting the lawful, off-label use of an FDA-approved drug.” According to this perspective article, the ruling stemmed from the argument that refusing to “allow the free flow of information would result in …limitations, and side effects of the drug.”
At stake is whether the ability of the FDA to combat false or misleading speech. In addition, limiting the FDA’s authority may lead to fewer studies documenting the effectiveness of medications for various indications. If the medication is approved for one use and there are no constraints on marketing, there will be little incentive to complete additional studies.