Transcript web.law.columbia.edu

Marketing to Doctors –
Payments for Loyalty
Julie Brill
Assistant Attorney General
Vermont Attorney General’s Office
Montpelier, VT 05609
802-828-5479
www.atg.state.vt.us
State legislation relating to payments to
doctors:
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Minnesota
Vermont
California
Maine
West Virginia
District of Columbia
www.atg.state.vt.us
Minnesota’s Fair Drug Marketing law: :
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Enacted in 1993, prohibits gifts over $50
with exceptions
Exceptions include:
(1) reasonable honoraria and payment of the reasonable
expenses of a practitioner who serves on the faculty at a
professional or educational conference or meeting;
(2) compensation for the substantial professional or
consulting services of a practitioner in connection with
a genuine research project
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Disclosure of payments over $100 required
Disclosures are in paper form
www.atg.state.vt.us
Vermont’s Gift Disclosure law:
Pharmaceutical companies must disclose to the
Attorney General information about payments to
prescribers, pharmacists and institutional
purchasers:
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Value
Nature
Purpose
Recipient
www.atg.state.vt.us
Vermont’s Gift Disclosure law:
Exempt from disclosure:
 Free samples
 Bona fide clinical trial payments
 Gifts under $25
 Scholarships to attend significant medical
conferences
 Unrestricted grants for CMEs (not after July 1,
2007)
 Rebates and discounts
www.atg.state.vt.us
Vermont’s Gift Disclosure law:
 Public reports issued over the past 3 years.
 Major findings from FY 05 include:
 68 pharmaceutical manufacturers spent $2.17
million on fees, travel expenses, and other direct
payments.
 five largest spenders were Forest, Eli Lilly, GlaxoSmithKline, Sanofi Aventis and Merck, which
together spent nearly 50% of the total reported
expenditures.
www.atg.state.vt.us
Vermont’s Gift Disclosure law:
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The top 100 recipients in FY 05 received a
total of $1,454,932, or two-thirds of the total
direct payments.
Psychiatrists were the largest beneficiaries of
gifts. Fifteen psychiatrists received a total of
$308,271.53, or approximately 14.21% of the
overall total. Average direct payment
received was $20,500.
www.atg.state.vt.us
www.atg.state.vt.us
Vermont’s Gift Disclosure law:
 Law allows companies to declare
disclosures “trade secret”.
 Has generated controversy
 JAMA March 07 article
 Public Citizen suit to obtain disclosures
www.atg.state.vt.us
Vermont’s Gift Disclosure law:
 Rationale for allowing trade secret
designation:
 Philip Morris v. Reilly (1st Cir En Banc 2002): public
disclosure of cigarette ingredient list is an
unconstitutional “takings”, because ingredient list is
a “trade secret”
 Breadth of “trade secret” is defined by state law.
www.atg.state.vt.us
Vermont’s Gift Disclosure law:
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Rationale for allowing trade secret designation
(cont’d)
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Vermont case law defines “trade secret” quite broadly.
Not just “intellectual property”.
“Any formulae, plan, pattern, process … or compilation of
information which is not patented, which is known only to
certain individuals within a commercial concern, and which
gives its user or owner an opportunity to obtain business
advantage over competitors who do not know it or use it.”
www.atg.state.vt.us
California’s Fair Drug Marketing law:
 Effective July 1, 2005
 requires every pharmaceutical company to adopt a
Comprehensive Compliance Program that is in
compliance with:
 OIG Guidance
 PhRMA Code
www.atg.state.vt.us
California’s Fair Drug Marketing law:
Requires pharmaceutical and device companies to:
 develop policies on interactions with health care
professionals
 have limits on gifts and incentives to professionals
 establish explicitly specific annual dollar limit on gifts,
promotional materials, or items or activities that the
pharmaceutical company may give/provide to a
professional, with certain exemptions
 annually declare, in writing, compliance with the
Comprehensive Compliance Program and make its
Comprehensive Compliance Program and written
acknowledgment of compliance available to the public
www.atg.state.vt.us
California’s Fair Drug Marketing law:
Gifts and incentives at issue include:
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gifts,
meals and entertainment,
hiring and payment of consultants, and
participation in speaker training and educational
conferences.
Enforcement authority unclear.
www.atg.state.vt.us
Maine’s Promotion Disclosure law:
With respect to promotional activities, Maine’s new
law requires, beginning in July 2007, disclosure
of:
 “advertising, marketing and direct promotion
expenses” in Maine;
 expenses associated with CMEs;
 gifts, including meals, travel, and samples; and
 detailing costs, including salaries.
www.atg.state.vt.us
Maine’s Promotion Disclosure law:
Three exceptions:
 Expenses of $25 or less;
 Bona fide clinical trial payments
 Scholarships to attend significant medical
conferences
www.atg.state.vt.us
Other state legislation relating to payments to
doctors:
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West Virginia – enacted in 2001, but still has
no implementation mechanism.
District of Columbia – enacted in 2004.
Unclear if data is currently required to be
reported, and if so what is happening to data.
www.atg.state.vt.us
State legislation relating to payments to
doctors: Issues to consider
1. Agency with enforcement authority
2. Make data available to the public
3. Electronic disclosures from companies
on standard forms
4. Date of payment
5. Include payments for devices?
www.atg.state.vt.us
State legislation relating to payments to
doctors: Issues to consider
6. Recipient disclosed by state license
number
7. Linking data to Medicaid or other state
payment data to determine effect of
payments on prescribing patterns.
8. Trade secret issues
9. On line queries by public
www.atg.state.vt.us