Judge Says Prescribing Data Can't Be Marketing Fodder
A federal judge has upheld a Vermont law that bars the release of physicians' prescribing information to drug companies, which then use the information for marketing purposes.
U.S. District Court Judge Garvan Murtha in April rejected a suit by“ data-mining” companies challenging the state law that bars access to prescribing records without consent of the prescribing physician.
As part of the data-mining process, third-party companies purchase prescribing information from pharmacy chains and the companies that manage drug benefits for employers and then sell it to drug companies. Drug companies pair physicians' professional information obtained from the AMA's database of member and nonmember physicians with physician-specific prescribing data to tailor sales pitches to individual clinicians.
In his decision in IMS v. Sorrel, Murtha also upheld the law's creation of an evidence-based education program for physician prescribers and creation of a consumer-fraud cause of action for advertisements printed, distributed, or sold in Vermont that violate federal law.
The ruling was based in part on the input of the Vermont Medical Society, which said that the use of prescribing data to market to clinicians intrudes on the way physicians practice medicine and creates the “possibility that representatives could exert too much influence on prescription patterns.”
Lawmakers crafting the measure cited evidence indicating that the use of prescriber profiles increased the cost of health care by fueling the marketing of only the most expensive brand-name medications.
“As the court found, this evidence adequately demonstrates that prescription data privacy regulations promote substantial state interests in cutting prescription drug costs and promoting evidence-based prescribing,” said Sean Flynn of the Program on Information Justice and Intellectual Property, which filed an amicus brief in support of the state law on behalf of the Vermont Medical Society, AARP, and other patient-privacy advocates.
The judge agreed with evidence that lawmakers cited in crafting the legislation indicating that data-driven marketing resulted in the prescription of newer medicines, which ran counter to evidence-based prescribing guidelines. He cited several specific examples of brand-name drugs that were widely prescribed over generic alternatives and were eventually pulled from the market after potentially lethal side effects were discovered.
The impact on health care costs in Vermont resulting from marketing based on data mining was cited by state legislators who backed the measure. Bill supporters noted that drug makers had been spending an estimated $10 million annually on prescriber-focused marketing in Vermont.
“This law certainly seems to return more control to physicians and gives them more awareness about what can or cannot happen to their patterns of prescribing,” said Jonathan Weker, M.D., secretary of the Vermont Psychiatric Association.
Murtha's decision was based in part on his conclusion that a substantial state interest existed in restricting such commercial activity. Legislators had delayed the law's start date until July so that the courts could rule on its constitutionality.
The case was consolidated with another lawsuit filed by the Pharmaceutical Research and Manufacturers of America (PhRMA), which sought to block part of the law requiring drug companies to pay a fee to support an“ evidence-based education” program for clinicians. The judge rejected PhRMA's argument that the provision unconstitutionally forced drug makers to fund a government-controlled message in which they had no input.
Three of the data-mining companies that challenged the Vermont law said in a written statement that the ruling would cost patients in Vermont more money by restricting the companies' ability to access prescribing data, and the companies raised the possibility of appealing Murtha's ruling.
The decision followed a federal appeals court ruling in November 2008 in the case IMS v. Ayotte, which upheld a New Hampshire law to restrict data mining (Psychiatric News, December 19, 2008). A similar Maine law, however, was overturned by a federal court in December 2007.
The ruling inIMS v. Sorrellis posted at<www.prescriptionproject.org/tools/solutions_resources/files/0040.pdf>.▪
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Published online: 5 June 2009
Published in print: June 5, 2009
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With input from the Vermont Medical Society, a district court upholds a state law that helps preserve the sanctity of the physician-patient relationship in prescribing practices.
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