The FDA approves drugs only for particular uses, but once a drug is approved as safe, doctors can use their medical judgment to prescribe them for whatever therapeutic purpose they wish. (Network newsmagazines sometimes try to pretend that this is a scandal, running fifteen-minute stories on the issue without once mentioning that it's entirely legal rather than the equivalent of a campus drug ring selling Ecstacy.)
Pharmaceutical companies sometimes run into trouble as a result; the FDA only allows them to advertise the drug for approved uses (accusing them of "misbranding" otherwise), and sales representatives earning commissions have the incentive to go outside of those regulatory bounds. Prosecutors strike hard when that happens, and the threat of debarment can extract billions of dollars from pharmaceutical companies whether or not they are culpable. The public policy problem is especially vexing when medical science is ahead of the regulatory decisionmaking. A pharmaceutical company is, according to the government, breaking the law if it truthfully states "Medical journal M published a study showing that drug D is effective in treating problem X," or even just distributes a copy of the published study. Forbidding the dissemination of truthful information has obvious First Amendment implications, but no pharmaceutical company dares litigate the issue: even aside from the possible consequences of bureaucratic retaliation by speaking out against regulators' power, the same threat of debilitating debarment makes it economically irrational to risk the randomness of the civil justice system, even if the drug company thinks it has a 95% chance of prevailing. This costs lives, as medicine moves faster than the over-cautious regulators do.
Until now. Alfred Caronia, a pharmaceutical sales representative, promoted the narcolepsy drug Xyrem to doctors for unapproved uses and subpopulations, such as "extended daytime sleepiness"—a use later approved by the FDA. His, employer, Jazz Pharmaceuticals, quickly settled for a $20 million fine, but Caronia faced criminal prosecution. He fought the law, was convicted, and appealed.
On appeal, argued in 2010, the Second Circuit reversed yesterday on First Amendment grounds in a 2-1 decision. Beck has thorough analysis that we won't repeat. Also: Gottlieb @ AEI; Bashman link roundup; and I'm sure MI's Medical Progress Today will have something to say.
Gottlieb writes that the decision "should prompt FDA to come up with a more balanced approach that allows findings from scientific studies to be disseminated even if these results aren't in the FDA-approved label and haven't met the agency's high bar." "Should," perhaps, but I'm skeptical about "will." The DOJ and FDA will fight Caronia through at least two more levels of appeal, and the economics of pharmaceutical companies refusing to fight the question means that the FDA and federal prosecutors have no incentive not to continue to overreach: they'll just bring their cases in one of the 47 states not bound by the Second Circuit.