Why you should care
As restrictions on corporate speech fall to the wayside, your medicine cabinet could get fuller — and its contents more dangerous, too.
The epic battle between government and big business has found a new frontier: your medicine cabinet.
With restrictions on corporate speech falling away, the Food and Drug Administration is now revising regulations that have long banned “off-label promotion,” or marketing medicine for uses the FDA has not approved. New regulations are due out this fall. There’s a good chance they’ll give drug companies much more latitude in marketing drugs to doctors.
Get ready for a whole lot of drug deals.
Opponents of the off-label promotion ban say it violates First Amendment speech rights and makes little practical sense in the information age besides. Supporters argue it protects patients and allows doctors to make medical judgments uncorrupted by Big Pharma’s big bucks.
All of this might sound esoteric, but the new regulations will affect some of your most intimate interactions — the ones in the examining room. They also could save drug makers billions in penalties and litigation.
For decades, the FDA has regulated how pharmaceutical reps can pitch doctors. One main proviso: They can’t discuss a drug’s “off-label” uses, or those that the FDA has not deemed safe and effective. For instance, Pfizer can market Zoloft to treat depression, an approved use, but can’t trumpet one of the drug’s lesser-known benefits — preventing premature ejaculation.
Doctors can still prescribe drugs for nonlabel indications, of course. The ban is meant to insulate that decision from commercial interests. Every year, pharmaceutical companies spend billions of dollars persuading doctors to prescribe their drugs, even more than they do on R&D. Some fear all that snazzy marketing could get the better of doctors’ best judgment. To them, the off-label promotion ban forms an integral part of “a larger medical system based on science and proof rather than one based on marketing and spin,” says Christopher Robertson, a law professor at the University of Arizona.
Times are tough for restraints on corporate speech.
But times are tough for restraints on corporate speech. In a 2011 case called Sorrell v. IMS Health Inc., the Supreme Court held that pharmaceutical marketing is “speech” and that the First Amendment protects a company’s right to use information about doctors’ prescribing habits to promote its drugs. According to Justice Anthony Kennedy, “[M]any are those who must endure speech they do not like, but that is a necessary cost of freedom.”
Lofty talk — perhaps better suited to, say, a war protester’s right to burn a flag than a pharmaceutical rep’s right to hawk her wares. Regardless, the FDA’s ban stands on ever-shakier constitutional ground— as one federal appeals court said after the Sorrell decision — and drug companies are salivating at the prospect of reduced litigation costs. (In 2012, GlaxoSmithKline paid $3 billion to settle charges related to its off-label promotion of Paxil and Wellbutrin, to cite one very costly example.)
But others worry that by slapping a free-speech header onto the FDA’s complex system of marketing regulations, the Supreme Court could distort the pharmaceutical market and threaten public health.
Eliminating the off-label promotion ban will lead to “market-driven medicine rather than medicine that is based on scientific evidence,” argues Stephanie Greene, a professor at Boston College’s Carroll School of Management. Companies would have an incentive to market expensive, brand-name drugs to consumers who may not need them, she says: “People tend to think they need what they hear about.” Robertson says that without the off-label promotion ban, “we will see more cost, and less health.”
One reason: Cost-benefit analyses might go out the window. For example, the FDA approved Actiq, a narcotic “lollipop” 80 times more potent than morphine, for cancer patients who didn’t find relief from other pain medications. Yet one study concluded that more than 80 percent of Actiq prescriptions were issued for routine ailments such as migraines and back pain, conditions that entail a vastly different cost-benefit ratio than terminal cancer. Actiq’s manufacturer, Cephalon Inc., eventually paid the government $425 million to settle allegations that it had marketed Actiq and other drugs for off-label uses.
Doctors, of course, have the final say over what drugs to prescribe, but few would deny that pharmaceutical marketing significantly influences their prescribing practices. Most physicians are too busy to spend their days digesting academic studies, so “instead,” says Robertson, “they rely on proxies and heuristics to get a sense of what drug might work for which illness,” and “one of the biggest impacts on prescribing is the pharmaceutical companies’ [sales] efforts.”
Those with a more libertarian, free-market bent argue that market-driven medicine is a good thing. Restricting the flow of information into the health care market impedes the invisible hand in its efforts to find optimal treatments. They also argue that the off-label promotion ban makes little sense in the information age, when nearly everyone except the drug manufacturer can talk about off-label uses.
For now, though, the Supreme Court has taken this debate from the hands of policymakers and placed its weighty thumb on the judicial scales in favor of libertarians. The upshot? Courts are poised to strike down the ban on off-label promotion if the FDA does not concede defeat with revised regulations this fall. Either way, prescriptions for unapproved uses are sure to increase, turning your medicine cabinet into a pricey and maybe hazardous frontier in the battle over corporate free speech.
Rhett Martin is a Southern boy practicing law in Madison, Wisconsin. He has eaten raccoon, likes a good black-tie soiree and reads Winnie-the-Pooh in Latin to his newborn baby girl Beck, who probably already thinks her dad is a weirdo.