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Of course, even if the courts do eventually establish a clear and unambiguous precedent holding off-label promotion to be constitutionally protected, that need not keep the FDA and federal prosecutors from hounding drug makers. The feds know that under federal anti-fraud laws, even charging a drug firm with mislabeling is enough to disqualify the company from selling any products at all to federal health programs, such as Medicare and the Veterans Health Administration. Even if the charge is later dismissed due to its unconstitutionality, an indictment alone could cost the firms billions of dollars in lost sales while the case is being litigated.
When faced with a threat of prosecution and the likely loss of billions in revenue, most companies capitulate and agree to pay a hefty fine and to refrain from the perfectly legal and constitutionally protected activity of off-label promotion. There have been dozens of examples, including Allergan, which agreed in 2010 to a $600 million settlement to resolve a case involving the promotion of its drug Botox for treatment of chronic migraines before FDA review or approval of the drug for that indication; and Endo Pharmaceuticals' agreeing in 2014 to pay $171.9 million to resolve liability for off-label promotion of topical anesthetic Lidoderm.
Businesses that might have gone to court to clear their names and defend their First Amendment rights have chosen not to do so in order to avoid a criminal indictment that could cost their shareholders billions. That is, in effect, legalized extortion by the government.
Fortunately, a new head of the FDA, Dr. Scott Gottlieb, appears to have brought with him a new attitude about the legality of off-label promotion. In early January 2017, during the Obama administration's final few days, the FDA issued a rule on "intended uses" that reiterated its view that off-label promotion renders a drug or medical device criminally mislabeled. The incoming Trump administration put a hold on that and all other new regulations, choosing to implement some and reverse many others. The FDA's intended-use rule was among those chosen for additional review, suggesting that the new administration may not let it go forward—and may, in fact, rewrite the document to clarify what kinds of off-label promotion will be considered legal. A final decision is expected sometime this month, and many observers are optimistic that the agency will finally acknowledge that the FDA is not immune to the First Amendment.
The government should be able to regulate commercial speech to ensure it is not misleading or fraudulent, but the First Amendment's guarantees would be weak indeed if they did not protect the right to utter, hear, and promulgate truthful, non-misleading information. As the Supreme Court concluded in the landmark 2002 case Thompson v. Western States Medical Center, which involved advertising by pharmacists, "the First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good." That excellent rule surely suggests that some types of off-label promotion are protected speech.
Henry I. Miller, a physician and molecular biologist, is the Robert Wesson fellow in scientific philosophy and public policy at Stanford University's Hoover Institution. Gregory Conko is deputy director of the George Mason University Law & Economics Center.
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