FDA Law Update
Posted at 1:00 PM on June 15, 2009 by Sheppard Mullin
Data Mining Bans and Restrictions
Pharmaceutical companies may face increasing hurdles in marketing their products to physicians
as states begin to ban prescription data mining. To date, legal challenges to such state laws have
largely failed. Prescription data mining is an important marketing tool for pharmaceutical
companies.
Health information organizations ("HIOs") create prescriber profiles by buying prescription
information (minus patient names) from pharmacies and cross-checking this information against
a list of individual physician prescription identities that are purchased from the American
Medical Association ("AMA").[1] These prescriber profiles include information such as the
physician's name, specialty, practice site, and which and how many prescriptions the physician
writes and are sold to pharmaceutical companies to allow their salespeople to tailor marketing
strategies to individual physicians. Currently, New Hampshire, Vermont, and Maine all have
laws banning prescription data mining. Other states, including Hawaii, Maryland, Massachusetts,
Nevada, New York, Washington, and the District of Columbia, have introduced legislation to
limit data mining. The restrictions contained in both the existing and the proposed legislation
target the sale and use of patient or prescriber data for marketing or commercial purposes. The
legislation does not limit the sale and use of such data for purposes such as insurance
reimbursement, dispensing prescriptions, utilization review, public health research, law
enforcement, adverse effects reporting, or compliance with Medicaid or private insurance rules.
In 2006, New Hampshire passed the Prescription Privacy Law, which prevents patient and
prescriber identifying data from being sold or used for advertising, marketing, promotion or any
activity intended to influence sales or market share of a pharmaceutical product. The law was
passed as a consumer protection and public health measure, and was intended to safeguard
privacy in prescribing.
In 2007, the Vermont legislature passed a law banning all use of prescriber data for marketing
purposes unless a physician explicitly agrees to waive the protections. Such a waiver would take
the form of an opt-in provision at the time of licensure or renewal and would be managed by
Vermont's professional licensing board.
Also in 2007, the Maine legislature passed the Maine Prescription Restraint Law, which
established a state-sponsored opt-out process for physicians, physician assistants and nurse
FDA Law Update
Posted at 1:00 PM on June 15, 2009 by Sheppard Mullin
Data Mining Bans and Restrictions
Pharmaceutical companies may face increasing hurdles in marketing their products to physicians
as states begin to ban prescription data mining. To date, legal challenges to such state laws have
largely failed. Prescription data mining is an important marketing tool for pharmaceutical
companies.
Health information organizations ("HIOs") create prescriber profiles by buying prescription
information (minus patient names) from pharmacies and cross-checking this information against
a list of individual physician prescription identities that are purchased from the American
Medical Association ("AMA").[1] These prescriber profiles include information such as the
physician's name, specialty, practice site, and which and how many prescriptions the physician
writes and are sold to pharmaceutical companies to allow their salespeople to tailor marketing
strategies to individual physicians. Currently, New Hampshire, Vermont, and Maine all have
laws banning prescription data mining. Other states, including Hawaii, Maryland, Massachusetts,
Nevada, New York, Washington, and the District of Columbia, have introduced legislation to
limit data mining. The restrictions contained in both the existing and the proposed legislation
target the sale and use of patient or prescriber data for marketing or commercial purposes. The
legislation does not limit the sale and use of such data for purposes such as insurance
reimbursement, dispensing prescriptions, utilization review, public health research, law
enforcement, adverse effects reporting, or compliance with Medicaid or private insurance rules.
In 2006, New Hampshire passed the Prescription Privacy Law, which prevents patient and
prescriber identifying data from being sold or used for advertising, marketing, promotion or any
activity intended to influence sales or market share of a pharmaceutical product. The law was
passed as a consumer protection and public health measure, and was intended to safeguard
privacy in prescribing.
In 2007, the Vermont legislature passed a law banning all use of prescriber data for marketing
purposes unless a physician explicitly agrees to waive the protections. Such a waiver would take
the form of an opt-in provision at the time of licensure or renewal and would be managed by
Vermont's professional licensing board.
Also in 2007, the Maine legislature passed the Maine Prescription Restraint Law, which
established a state-sponsored opt-out process for physicians, physician assistants and nurse
Document hosted at
http://www.jdsupra.com/post/documentViewer.aspx?fid=4ec6e818-39a7-4cf9-a2a6-d4e2ff72c826
