New Hampshire pharmacists, PBMs, and insurers have a constitutional right to sell prescribing information to medical data companies such as IMS Health and Verispan--or so argue IMS and Verispan in their recently filed lawsuit against the state.

The suit, filed Friday in US District Court in Concord, NH, concerns the Prescription Restraint Law. The law, which went into effect June 30, prohibits physician-identifiable data from being "licensed, transferred, used, or sold by any pharmacy benefits manager, insurance company, electronic transmission intermediary, retail, mail order, or Internet pharmacy or other similar entity, for any commercial purpose."

Medical data companies like IMS and Verispan are dependent on these third parties for such prescribing data, which they aggregate and disseminate to pharmaceutical companies.

The medical data companies are challenging the law on the grounds that sharing prescribing data is a form of free speech, which under the First Amendment, can't be restricted. Under HIPAA, patient-identifiable data is protected. But IMS and Verispan argue in their lawsuit that physicians do not have that same right to privacy.

The companies also argue that the law is vague, overreaches in scope, and violates interstate commerce laws.

"The New Hampshire bill prohibits the speaking of something that's lawful," said Fred Cate, a senior policy advisor at the Center for Information Policy Leadership. The center is affiliated with Hunton & Williams, one of the law firms representing IMS and Verispan. "That's a first in the nation."

Cate, an attorney who is not working on the case, noted that states are free to regulate marketing activities--such as gifts to doctors--and even drug prices. But he questioned the constitutionality of curbing speech in order to accomplish those objectives.

Both IMS and Verispan argue that the data is used for a number of public health purposes, at a cost that is now borne by drug makers. If pharmaceutical companies no longer have access to meaningful data, there will be no one to pay for its collection, they add.

"FDA relies on the pharmaceutical manufacturers to contact [physicians who might be] affected," said Robert Hunkler, director of professional relations at IMS, pointing to a recent FDA warning about mixing SSRIs and triptans, a class of migraine medications. "Without that information, we're hamstrung."

The New Hampshire legislature "eliminated the resources that make it possible for this data to be collected," said Charlie Arlinghaus, president of the Josiah Bartlett Center for Public Policy, a non-partisan think tank in New Hampshire that opposes the law. "There are very serious potential unintended consequences."

For one, the law could deter pharma and biotech investment in the state, which is home to Dartmouth University. "It is a horrible economic development message," said Arlinghaus.

Representatives from the New Hampshire governor's office and the Department of Health and Human Services did not respond to requests for comment.

As a market, New Hampshire makes up less than one percent of raw information, Hunkler noted. But, "It's a matter of principle," he said. "We think that the law and others like it rob the healthcare system of valuable data."

Jody Fisher, vice president of product management for Verispan, noted that the prescribing database was originally intended to help recruit investigators for clinical trials. "We truly believe this data has a public benefit," he said.

Verispan supports the American Medical Association's prescribing data restriction program (PDRP), which went into effect July 1 and allows physicians to opt-out of sharing their prescribing activity. That program allows industry executives to access the data as long as they don't provide it to their sales reps.

There are currently about 3,500 physicians who have opted into that program, up from 2,900 two weeks ago. Despite the jump, the number represents less than half a percent of all practicing physicians.

Hunkler said the numbers reflect what surveys indicated all along: simply having the option to restrict their prescribing data alleviates physicians' concerns.

"I think the PDRP is really the best of both worlds," Fisher said. "It seems to achieve the objective that the intent of the [New Hampshire] law set out to do."