Once again, PPC is leading the way in support of thoughtful policy that promotes evidence-based prescribing—this time in the courts. It isn’t enough to pass laws and fund programs—if drug makers and other industry groups challenge these initiatives in court, good policy can go down the drain without a vigorous defense.

New Hampshire’s law banning the marketing use of certain “data mined” prescriber information has already been upheld by the First Circuit Court of Appeals (with the US Supreme Court refusing to review the result), and the law is finally being implemented. Vermont’s law, which bans marketing uses of individually identifiable prescriber information unless the health provider “opts in” and grants permission, is still tied up in the courts, despite a Federal District Court decision upholding the law.

In October, the Second Circuit Court of Appeals in New York City heard oral argument in the data mining industry’s appeal, and PPC had a major role shaping the legal arguments the court is now considering. PPC filed a “friend of the court” legal brief supporting Vermont, joined by AARP, Community Catalyst, and NLARx (National Legislative Association on Prescription Drug
Prices).

“The insertion of the pharmaceutical company into the monitoring and influence of the patient’s treatment is an invasion of privacy-–one that directly
affects treatment courses through influences that are nearly impossible for the patient to detect,” said attorney Meredith Jacob, who is pharmaceutical policy fellow at American University’s Washington College of Law and part of PPC’s legal team. Jacob also noted that the use of “anonymous” patient level data and physician-identifiable prescription data “skews prescribing choices and increases costs by allowing marketers to target individual, though unnamed, patients through data-driven marketing to physicians.”

Kevin Outterson, a PPC board member and Boston University School of Law professor, also defended Vermont’s law. Outterson, joined by two other law professors, authored a brief on behalf of physicians, representing the New England Journal of Medicine, the Vermont Medical Society, the Massachusetts Medical Society, the New Hampshire Medical Society, the National Physicians Alliance, and the American Medical Student Association.

Vermont Attorney General William Sorrell, who has the primary responsibility for defending state law, made a strong case for the Vermont data mining
statute. Vermont’s brief pointed out that “. . . a detailed evidentiary record shows that the problem of aggressive and intrusive, targeted marketing using prescriber-identifiable data is real. It causes unnecessary, expensive, and potentially risky over-prescription of new drugs. It also invades doctors’ privacy and intrudes on the doctor-patient relationship.”

Four states now have anti-data mining rules in place: Maine, New Hampshire, Vermont, and Massachusetts (by regulation). The Vermont case has been argued, but it may be many months before the decision is published. Other states shouldn’t be deterred from adopting laws promoting evidence-based prescribing by restricting the marketing use of data-mined health records. With careful attention to insuring the legislative record includes the many studies about marketing practices and impacts on appropriate prescribing and legislation that is narrowly tailored to the problem, we believe these laws can and will be upheld by the courts. We are hopeful that, if we succeed in the Vermont case, these issues will be finally resolved and other states will not face costly and obstructionist litigation.