Freedom of Information - Pharmaceutical Executive


Freedom of Information
IMS and Verispan sue New Hampshire to buy prescriber data—and to protect the data sellers' free-speech rights.

Pharmaceutical Executive

"If Not Us, Then Who?"

IMS and Verispan also insist that physician-identified prescribing data serves greater causes, like the overall public health of the nation. Once the data is collected, the companies provide it free of charge to researchers at places like FDA, the Institutes of Medicine, the Mayo Clinic, and the American Red Cross.

"By enacting these sorts of restrictions, other uses of the data—beyond what the pharmaceutical companies use it for—would likely be restricted," says Stafford, the assistant professor from Stanford. Stafford is currently participating in a federal initiative to educate physicians on the results of the ALLHAT study, which found that older blood-pressure medications are just as good as newer ones. His role in the initiative is to use the data to evaluate the effectiveness of those education efforts—to see if physicians have switched their patients to the older (and perhaps less expensive) products.

But Stephen says there is no restriction on compiling the data for research purposes. "The data is still available to the government," he says. "The data is still available to Medicare."

Not good enough, say IMS and Verispan, which argue that if pharmaceutical companies no longer have access to meaningful data, there will be no one to pay for its collection—or to use it in times of crisis.

"FDA relies on the pharmaceutical manufacturers to contact affected [physicians]," says 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."

In addition to their Constitutional and public-health arguments, IMS and Verispan argue that the Prescription Restraint Law is vague, overreaches in scope, and violates interstate commerce laws.

"It's not clear in some cases which attributes are identifiable," says Jody Fisher, vice president of product management for Verispan, referring to the fact that data companies can still collect prescribing information that masks the prescriber. For instance, the law allows the collection of zip code-level data—but what if there is only a single prescriber within that zip code? Or only one with a particular specialty?

The suit also points out that New Hampshire is trying to legislate commerce occurring in other states. Not only is the data aggregated and used outside the state, but New Hampshire doctors write many prescriptions that are filled out of state.

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

As a market, New Hampshire provides less than one percent of raw information compiled by IMS, says Hunkler, but the issue is larger than the volume of data."It's a matter of principle," he says. "We think that the law and others like it rob the healthcare system of valuable data."

Some observers fear that the new law could deter pharma and biotech companies from investing in the state, which is home to Dartmouth University. "It is a horrible economic-development message," says Charlie Arlinghaus, president of the Josiah Bartlett Center for Public Policy, a non-partisan think tank in New Hampshire that opposes the law.

Other critics of the law worry that it could have a spillover effect into other states, a number of which have already passed—or are trying to pass—measures designed to limit pharma's physician-directed marketing activities.

"There are a lot of states in a holding pattern," says Jim Alonso, chairman and CEO at ASI Business Solutions, which makes compliance software. "New Hampshire is the first domino that has fallen."

Voluntary Alternative

Many opponents of the New Hampshire law are instead backing the American Medical Association's prescribing data restriction program (PDRP), which went into effect July 1 and allows physicians to decline to share their prescribing data.

And because the PDRP is voluntary, it encourages drug reps to improve their interactions with doctors, supporters note. "The concern that started all this was the inappropriate use of this data by sales reps," says Verispan's Fisher. "We don't condone this use at all."


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