Court Rejects Law Restricting Access to Prescribing Data

The U.S. Supreme Court has ruled unconstitutional a 2007 Vermont law that restricts the sale, disclosure, and use of physicians' prescribing data for commercial purposes.

Vermont's intention was to prevent third-party "data miners" from purchasing this information from pharmacies and using the data to help pharmaceutical companies devise physician-specific marketing strategies. The high court, however, sided with the defendants in the case (Sorrell v. IMS Health), finding the law to be a violation of the companies' free-speech rights.

The goal of the Prescription Confidentiality Law is to protect the physician-patient relationship from outside influence and prevent pharmaceutical company "detailers" from encouraging clinicians to prescribe newer, more expensive medications. And while U.S. District Court Judge J. Garvan Murtha upheld the law in June 2009, the 2nd U.S. Circuit Court of Appeals overturned that ruling in November 2010. The Supreme Court agreed to hear the case in January of this year (see Data-Mining Laws' Ups and Downs).

In the 6-3 majority opinion written by Justice Anthony Kennedy, the high court rejected the state's argument that the law "is a mere commercial regulation." According to Kennedy, the defendants' "creation and dissemination of information" is protected under the First Amendment.

Further, the Court asserted that the law's opt-out provision for physicians wishing to maintain confidentiality offers a "contrived choice" that favors the interests of the state.

Attorneys defending Vermont's law had also argued that the marketing efforts of pharmaceutical companies are tantamount to physician harassment. The Court dismissed this line of argument too, maintaining that physicians can simply choose not to meet with drug-company representatives. Similarly, the Court rejected the charge that drug reps' tactics have the potential to influence how physicians treat their patients: "[T]he fear that speech might persuade provides no lawful basis for quieting it."

"The State's interest in burdening the speech of detailers ... turns on nothing more than a difference of opinion," the Court concluded.

Dissenters Question Court Precedence

Supreme Court Justice Stephen Breyer argued in favor of the law's constitutionality in his dissenting opinion, asserting that the Court has previously supported statutes designed to regulate "commercial speech" and had never questioned governmental restrictions on "the use of information gathered pursuant to a regulatory mandate."

According to Breyer, the statute "neither forbids nor requires anyone to say anything, to engage in any form of symbolic speech, or to endorse any particular point of view, whether ideological or related to the sale of a product."

Breyer contended that the Supreme Court should evaluate the law "under the standard appropriate for the review of economic regulation."

"The Vermont statute ... deprives pharmaceutical and data-mining companies of data ... that could help pharmaceutical companies create better sales messages," Breyer wrote. "In my view, this effect on expression is inextricably related to a lawful governmental effort to regulate a commercial enterprise."

Breyer also backed the state's argument that customized marketing plans can impede clinicians' focus on the safety, efficacy, and cost of a given medication.

"This diversion comes at the expense of public health and [Vermont's] fiscal interests," Breyer noted.

Physician Groups, Politicians Weigh In

Many physicians throughout the state supported Vermont's data-mining law. And five medical associations representing clinicians from across the country joined the Vermont Medical Society (VMS) in filing an amicus brief with the Supreme Court in support of the data-mining prohibition.

"Vermont's physicians are disappointed the Supreme Court overturned Vermont's data-mining ban," said VMS Executive Vice President Paul Harrington. "Physicians were completely unaware that pharmaceutical companies had access to this information when they were coming to the physicians' offices."

Despite the high court's rejection of the Vermont law as currently written, APA Treasurer David Fassler, M.D., a Vermont psychiatrist, expressed hope that some tweaking of the law's language could result in passage of a statute with similar objectives.

"This case raised interesting legal issues clearly not contemplated by the sponsors of the original legislation," Fassler said. "I expect state officials are reviewing the opinion to see if the law can be modified in a manner that would comply with the Court's decision. I doubt we've heard the end of the issue."

U.S. Sens. Patrick Leahy (D-Vt.) and Bernie Sanders (I-Vt.) were more critical of the ruling and its implications, accusing the Supreme Court's majority of unfairly siding with the pharmaceutical companies.

"This decision is another example of the Court using the First Amendment as a tool to bolster the rights of big business at the expense of individual Americans," Leahy said. "State legislatures should be allowed to protect their citizens' privacy rights over corporate interests in profits."

Five days after declaring Vermont's Prescription Confidentiality Law unconstitutional, the Supreme Court ordered the 1st U.S. Circuit Court of Appeals in Boston to review its decision on Maine's data-mining law in light of the Vermont ruling. That court had upheld the constitutionality of the Maine law.

On July 8, U.S. Rep. Ed Markey (D-Mass.) introduced a house resolution (H.Res. 343) expressing disapproval of the Court's decision in Sorrell v. IMS Health. The resolution states that the Court "incorrectly applied a ‘heightened’ First Amendment standard of review to an instance of commercial regulation."

The Supreme Court's decision is posted at <www.supremecourt.gov/opinions/10pdf/10-779.pdf>.