[Med-privacy] New Hampshire ban on sale of prescribing data upheld

[peter marshall]

amednews.com

New Hampshire ban on sale of prescribing data upheld
The court said drugmakers' use of doctors' prescribing information is 
not protected speech.

By Kevin B. O'Reilly, AMNews staff. Dec. 22, 2008.

A federal appeals court ruling that upheld New Hampshire's ban on 
commercial use of prescribing data could clear the way for other states 
to pursue legislation restricting drugmakers' access to information 
they use to tailor marketing pitches to doctors.

The 1st U.S. Circuit Court of Appeals in November found that the 2006 
New Hampshire law did not violate the First Amendment, overturning a 
lower court ruling. The court's three-judge panel rejected the 
plaintiffs' argument that the law prohibited free flow of information.

The judges said the law regulates conduct, not speech, and the state 
had presented evidence to show that prescribing data was used to 
fine-tune drug reps' marketing pitches for higher-cost, brand-name 
drugs that were not always more efficacious.

"While the plaintiffs lip-synch the mantra of promoting the free flow 
of information, the lyrics do not fit the tune," wrote U.S. Court of 
Appeals Judge Bruce M. Selya in his opinion.

The plaintiffs in the case, data analysis firms IMS Health Inc. and 
Verispan LLC, now part of Surveillance Data Inc., said in a statement 
they are reviewing the decision and evaluating potential next steps.

They can ask for the 1st U.S. Circuit's full bench to review the 
three-judge panel's decision. The plaintiffs also could appeal to the 
U.S. Supreme Court.

The Pharmaceutical Research and Manufacturers of America was 
disappointed by the decision. "This ruling will make it more difficult 
for doctors -- and through them, patients -- to obtain the most current 
information about medicines," PhRMA Vice President Ken Johnson said in 
a statement.

Proponents of restricting drugmakers' access to prescribing data 
greeted the court ruling as a green light for more aggressive 
legislation.

"You will see states moving ahead, based on this," said Sharon Anglin 
Treat, a Maine state representative and executive director of the 
National Legislative Assn. on Prescription Drug Prices, a coalition of 
legislators that advocates legislation targeting pharmaceutical 
marketing.

The decision of the appeals court "cleared the way for states to do a 
very strong piece of legislation that's basically a ban on the use of 
data from prescribers, without the complications of opt-in or opt-out," 
Treat said.

At least 15 states over the past two years considered bills to restrict 
access to prescribing data, but some of the bills were withdrawn after 
the unfavorable lower court ruling in New Hampshire, Treat said.
Medicine split on handling data

The New Hampshire Medical Society strongly backed the state's ban on 
commercial use of prescribing data and was party to an amicus brief 
arguing that the law be upheld.

"The law was regulating conduct, not speech, and the type of conduct 
we're talking about is the capacity for drug salespeople to be able to 
tailor their sales pitches to physicians, knowing the behavior of how 
they prescribe different medications," said Marc Sadowsky, MD, a 
Nashua, N.H., psychiatrist and former president of the state society. 
"We're looking forward to seeing how things might work in New Hampshire 
with that weapon taken away from them."

Vermont and Maine are the only other states with laws similar to New 
Hampshire's. Neither adopted a complete ban on the sale of prescribing 
data, however. In Vermont, physicians can opt-in to let drugmakers 
access their prescribing records. In Maine, doctors can opt-out.

In 2006, the Vermont Medical Society adopted a resolution saying "the 
use of physician prescription information by sales representatives is 
an intrusion into the way physicians practice medicine" and that 
commercial use of such data should be restricted. The society supports 
the Vermont law.

The Maine Medical Assn., meanwhile, opposed the opt-out law passed 
there. The organization says the AMA's Physician Data Restriction 
Program, which allows doctors to keep prescribing data out of the hands 
of drug reps, addresses the problem.

Jeremy A. Lazarus, MD, speaker of the AMA House of Delegates, said in a 
statement that the Association's voluntary opt-out program "eliminates 
the need for restrictive legislative action."

More than 18,600 doctors have enrolled in the data-restriction program. 
Drugmakers still have access to prescribing data, which are used for 
safety and marketing purposes, but the information is not provided to 
detailers or their immediate supervisors.



  ADDITIONAL INFORMATION:
Case at a glance

Does a ban on commercial use of prescribing data violate free speech?

The court said no. The New Hampshire law at issue regulates commercial 
conduct that can lead to higher prescription drug costs, not 
constitutionally protected speech.

Impact: The federal appeals court ruling represents a major setback to 
data-mining firms that had won two lower-court rulings. The decision 
could set off a flurry of legislative attempts to restrict drugmakers' 
access to physician prescribing data, experts said.

IMS Health Inc. and Verispan LLC v. Kelly A. Ayotte, New Hampshire 
Attorney General, 1st U.S. Circuit Court of Appeals, Boston

Weblink

IMS Health Inc. and Verispan LLC v. Kelly A. Ayotte, New Hampshire 
Attorney General, 1st U.S. Circuit Court of Appeals, Nov. 18, in pdf 
(www.ca1.uscourts.gov/pdf.opinions/07-1945P-01A.pdf)

AMA Physician Data Restriction Program 
(www.ama-assn.org/go/prescribingdata)


Copyright 2008 American Medical Association.