Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations.
What got the storm brewing was a freshman state representative in Concord, NH, who, in May 2006, succeeded in persuading her colleagues to adopt the first law in the nation to stop pharmacies from selling information gleaned from prescriptions. Over time, this had become a very big business, since the information revealed the prescribing habits of doctors. Drug makers could use the information to guide their sales forces.
This legislator believed the information was driving up Medicare and Medicaid costs needlessly by helping pharma persuade doctors to prescribe the most expensive new medicines irrespective of their benefits, but she presented no research to determine whether this was so.Data mining companies challenged the law on First Amendment grounds, arguing that mere fear of the truth cannot warrant its suppression, and that it was more likely that the information was improving health and safety than harming it. Sources talking to reporters, and pharmacies selling data to manufacturers, represent two examples of communicating information that could be used for important purposes; the First Amendment protects both.
Notwithstanding the challenge, Maine and Vermont passed similar laws and the data miners challenged them too.
Five years and many legal briefs later, the Supreme Court handed down Sorrell v. IMS Health in 2011, holding that Vermont's law (and by implication those of Maine and New Hampshire) did indeed violate the First Amendment, because the data it restricted was truthful, the state could not show its suppression prevented any harm, and the state had other means of keeping costs down without suppressing truthful speech.
Now the FDA is feeling the full force of that decision as it tries to defend its own truth-suppressing regime. In United States v. Caronia, the Second Circuit Court of Appeals relied on Sorrell in a 2-1 decision to invalidate the conviction of Alfred Caronia for conspiracy to introduce a misbranded drug into interstate commerce.
The result was all but mandated by Sorrell because Vermont and its supporters had argued that if Vermont's law could not stand, then neither could the FDA's off-label marketing ban. The argument was designed to scare the Supreme Court into upholding the Vermont law. It worked on just three of the nine justices. Justice Breyer, writing for himself and two others, warned in his dissent that "the same First Amendment standards that apply to Vermont here would apply to similar regulatory actions taken by other states or by the federal government acting, for example, through Food and Drug Administration (FDA) regulation."