Court strikes down law protecting doctors' prescription data.

A federal court in New Hampshire recently held that a state law prohibiting data-mining companies from selling doctors' prescription-writing data to pharmaceutical companies violated the First Amendment. (IMS Health, Inc. v. Ayotte, 2007 WL 1244077 (D.N.H. Apr. 30, 2007).) The law went into effect in June 2006 and is the first of its kind.

Data-mining companies combine prescription data from pharmacies with data about doctors from the American Medical Association (AMA) and sell it to drug companies, which use it to tailor their marketing practices. Patient information is removed, but the drug companies can track all the prescriptions that a specific doctor writes and determine how much of a drug he or she is prescribing.

Through "detailing," a practice aimed at persuading doctors to prescribe a specific brand-name drug, pharmaceutical company representatives give doctors information about the drug, free samples, meals, and small gifts. Such gifts are common, but if the detailer who brings lunch into the doctor's office every Tuesday knows that the doctor isn't prescribing the promoted drug, is he or she likely to pressure the doctor? Some doctors think so.

In response to such concerns, the AMA implemented an opt-out program called the Physician Data Restriction Program in July 2006. The program stipulates that if doctors opt out, pharmaceutical companies can get the doctors' prescribing information, but they cannot share it with their sales representatives.

"The opt-out only means that pharmaceutical companies have agreed not to release individual provider information to their drug detailers, but there is no law that prevents them from doing so," according to an issue brief from the Reston, Virginia-based National Physicians Alliance (NPA). Another reason the opt-out program doesn't go far enough is that many physicians don't even know it exists, the NPA said.

Paul Sizemore, a Los Angeles lawyer who litigates pharmaceutical cases, said detailers may also pressure doctors not to opt out. He added, "I don't think most doctors would take the time to do it. It won't stop detailers from coming"--just from having doctors' specific information.

"The detailers can tell more accurately what prescriptions the doctors have written than [the doctors] can," Sizemore said, adding that he learned from some of his cases that detailers can access prescription data easily. A detailer can download a doctor's data remotely, immediately before going into the doctor's office, he explained. The data includes trends, such as whether the doctor is prescribing more or less of a specific drug over time, and more or less than other prescribers.

New Hampshire's Prescription Information Law was intended to safeguard this data--to shield physician privacy, protect patient health and safety, and contain health care costs. IMS Health, Inc., and Verispan, the nation's largest prescription-data-mining companies, sued the state, alleging that the law violates their free-speech rights. Judge Paul Barbadoro agreed, holding that the law improperly restricts commercial speech.

New Hampshire Attorney General Kelly Ayotte argued that the law does not regulate speech, so it is not subject to the First Amendment. But the court held that the law "is not exempt from First Amendment review merely because it targets factual information rather than viewpoints, beliefs, emotions, or other types of expression."

Barbadoro held that the information amounts to commercial speech subject to intermediate scrutiny. He found that the attorney general failed to sufficiently prove that the law directly advances the state's interest in promoting public health and containing health care costs.

"[A]lthough the attorney general asserts that pharmaceutical companies use prescriber-identifiable data to 'pressure' health care providers, she did not even attempt to prove at trial that they use the data to improperly coerce or harass health care providers," Barbadoro wrote.

Ayotte argued that detailing drives up health care costs because it causes doctors to prescribe more expensive brand-name drugs rather than generics.

Sizemore agreed. "It's the difference between $3-per-pill Celebrex and 15 cent-per-pill naproxen," he said. "That drives up costs for the patient and the health care system."

The NPA supports legislative bans like New Hampshire's because they "will save money by reducing the aggressive marketing by drug companies that contributes to inappropriate and more expensive prescriptions."

Ayotte announced in May that she would appeal the decision. At least 13 states have proposed legislation that would prohibit the sale or redistribution of prescription information that identifies patients or prescribers, according to the National Conference of State Legislatures.

The New Hampshire decision is likely to have a chilling effect on this legislation, Sizemore said, because "legislatures will be concerned about spending taxpayer money, through the attorney general, defending it." However, he suggested that other states may be able to tailor their laws more narrowly.

"Physicians are entrusted by society to act in their patients' best interests, yet physicians are demonstrably influenced by the marketing strategies of drug detailers," the NPA's issue brief says. "The best way to ensure that physicians retain the trust of patients is to warrant it, by eliminating this commercial intrusion into the doctor-patient relationship."