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www.atg.state.vt.us
Marketing to Doctors –
Payments for Loyalty
Julie BrillAssistant Attorney GeneralVermont Attorney General’s
OfficeMontpelier, VT 05609
802-828-5479
www.atg.state.vt.us
State legislation relating to payments to doctors:
Minnesota Vermont California Maine West Virginia District of Columbia
www.atg.state.vt.us
Minnesota’s Fair Drug Marketing law: :
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
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: 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, Glaxo-SmithKline, Sanofi Aventis and Merck, which together spent nearly 50% of the total reported expenditures.
www.atg.state.vt.us
Vermont’s Gift Disclosure law:
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:
Rationale for allowing trade secret designation (cont’d) 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: 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:
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
