A federal judge has upheld a Vermont law that bars the release of
physicians' prescribing information to drug companies, which then use the
information for marketing purposes.
U.S. District Court Judge Garvan Murtha in April rejected a suit by"
data-mining" companies challenging the state law that bars access
to prescribing records without consent of the prescribing physician.
As part of the data-mining process, third-party companies purchase
prescribing information from pharmacy chains and the companies that manage
drug benefits for employers and then sell it to drug companies. Drug companies
pair physicians' professional information obtained from the AMA's database of
member and nonmember physicians with physician-specific prescribing data to
tailor sales pitches to individual clinicians.
In his decision in IMS v. Sorrel, Murtha also upheld the law's
creation of an evidence-based education program for physician prescribers and
creation of a consumer-fraud cause of action for advertisements printed,
distributed, or sold in Vermont that violate federal law.
The ruling was based in part on the input of the Vermont Medical Society,
which said that the use of prescribing data to market to clinicians intrudes
on the way physicians practice medicine and creates the "possibility
that representatives could exert too much influence on prescription
patterns."
Lawmakers crafting the measure cited evidence indicating that the use of
prescriber profiles increased the cost of health care by fueling the marketing
of only the most expensive brand-name medications.
"As the court found, this evidence adequately demonstrates that
prescription data privacy regulations promote substantial state interests in
cutting prescription drug costs and promoting evidence-based
prescribing," said Sean Flynn of the Program on Information Justice and
Intellectual Property, which filed an amicus brief in support of the state law
on behalf of the Vermont Medical Society, AARP, and other patient-privacy
advocates.
The judge agreed with evidence that lawmakers cited in crafting the
legislation indicating that data-driven marketing resulted in the prescription
of newer medicines, which ran counter to evidence-based prescribing
guidelines. He cited several specific examples of brand-name drugs that were
widely prescribed over generic alternatives and were eventually pulled from
the market after potentially lethal side effects were discovered.
The impact on health care costs in Vermont resulting from marketing based
on data mining was cited by state legislators who backed the measure. Bill
supporters noted that drug makers had been spending an estimated $10 million
annually on prescriber-focused marketing in Vermont.
"This law certainly seems to return more control to physicians and
gives them more awareness about what can or cannot happen to their patterns of
prescribing," said Jonathan Weker, M.D., secretary of the Vermont
Psychiatric Association.
Murtha's decision was based in part on his conclusion that a substantial
state interest existed in restricting such commercial activity. Legislators
had delayed the law's start date until July so that the courts could rule on
its constitutionality.
The case was consolidated with another lawsuit filed by the Pharmaceutical
Research and Manufacturers of America (PhRMA), which sought to block part of
the law requiring drug companies to pay a fee to support an"
evidence-based education" program for clinicians. The judge
rejected PhRMA's argument that the provision unconstitutionally forced drug
makers to fund a government-controlled message in which they had no input.
Three of the data-mining companies that challenged the Vermont law said in
a written statement that the ruling would cost patients in Vermont more money
by restricting the companies' ability to access prescribing data, and the
companies raised the possibility of appealing Murtha's ruling.
The decision followed a federal appeals court ruling in November 2008 in
the case IMS v. Ayotte, which upheld a New Hampshire law to restrict
data mining (Psychiatric News, December 19, 2008). A similar Maine
law, however, was overturned by a federal court in December 2007.