NEJM: Restrictions on prescribing drug promotion is unconstitutional

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The U.S. Supreme Court recently declared unconstitutional Vermont’s law, which restricted detailing, the transferring and use of physician-identifiable prescribing data, that had been challenged by Vermont, New Hampshire and Maine. Prescription drug intermediaries (PDIs) and a pharmaceutical manufacturers’ association challenged Vermont’s law as a restriction to free speech on the basis of an expressed viewpoint. An article in the Aug. 3 issue of the New England Journal of Medicine shows that data mining reports created by PDIs and then later sold to pharmaceutical companies show a physicians’ prescribing behavior and whether the physician is an early or late medicine adopter.

Critics object to detailing of prescribing information, however, physicians often have mixed views about it. They understand that pharmaceutical sales presentations can be biased and generally disapprove of the use of their prescribing data, however, many physicians still find the pharmaceutical manufacturers presentations and free samples valuable, according to the article, written by by Michelle M. Mello, JD, PhD, from the department of health policy and management at the Harvard School of Public Health in Boston, and Noah A. Messing, JD, from the Yale School of Law in New Haven, Conn.

Vermont’s law had prohibited pharmacies and PDIs from selling, licensing or exchanging prescriber-identifiable prescription information and permitting it from being used for drug promotion. Pharmaceutical manufacturers and marketers were also prohibited from using this information for marketing purposes. Physicians in Vermont—much like New Hampshire and Maine—could “opt-in.” But Vermont restricted the data altogether unless a physician opted in; Maine allowed its use unless a physician opted out; and New Hampshire, whose law was also overruled, had banned its use.

In adopting its law, Mello and Messing wrote that Vermont had wanted to avoid public health harm associated with over-prescribing of new drugs, controlling costs by limiting practices that promote expensive, branded drugs over generics and protecting physicians’ privacy. Vermont did not include the risks to patients’ privacy, even though data miners may also identify patients by triangulating their information about sex, age and drugs prescribed.

The legal challenges to Vermont’s law alleged violations of free speech rights. Those mining the data said they had a right to obtain the information from pharmacies and communicate it; and the pharmaceutical companies said they had a right to use prescribing data to shape their conversations with physicians.

Vermont argued the sale of data involved, not speech, but an economic transaction akin to the sale of other commercial products, adding that the transfer of prescribing data could be regulated.

But both parties said the data transfers involved commercial speech—a hybrid of commerce (which states can regulate) and fully protected speech (which states cannot restrict). The Supreme Court looked at commercial speech in light of a 1980s "Central Hudson" test. That legal test says the government must show that regulations restricting commercial speech meet three requirements: It must serve a substantial state interest, it must directly and materially advance that interest and it must be “tailored”—meaning it is neither too narrow to address the problem nor broader than needed, Mello and Messing wrote.

The data miners and pharmaceutical companies said that Vermont’s law could not withstand a 1980s "Central Hudson" test, arguing that the Supreme Court should abandon it and not look at commercial speech as constitutionally inferior to political communications.

In striking down Vermont’s law, the Justices held the statute unconstitutional. The Court said the law restricted only data sales related to marketing and only when certain parties (e.g., pharmaceutical manufacturers) were involved. The Supreme Court ruled the law improperly targeted companies that were expressing a viewpoint—advocating for the prescribing of branded drugs.

As to Vermont’s physician privacy concern, the Court found that the statute was “not drawn to serve that interest” because pharmacies could share prescribing information “with anyone for any reason” except marketing. Nor could the state’s opt-in provision, which forced doctors to allow either everyone to use their prescribing data or everyone Vermont supported, but gave no option to curtail the data’s use, the authors wrote.