Vermont AWP Disclosure and Drug Marketer Gift Reporting LawsJune 2, 2004
New Price Disclosure Law:
In June 2004, Vermont enacted a drug price disclosure law which requires pharmaceutical companies doing business in Vermont to disclose the Average Wholesale Price (AWP) as reported to a nationally recognized drug pricing file, such as First DataBank, for the company’s drug and all competing products in each communication to a prescriber in Vermont. See H. 768 section 128c (attached appropriations bill at page 104). The Vermont Attorney General, in proposed guidance, has interpreted the law to require the AWP disclosures in each detail, e-mail, or phone call to a prescriber, and each journal advertisement distributed primarily in Vermont. A copy of the Attorney General’s proposed guidance is attached as well. Comments on the Attorney General’s proposed guidance are due November 15, 2004.
Amendments to Gift Reporting Law:
In the same appropriations bill, Vermont also amended its pharmaceutical marketer gift reporting law, Vt. Stat. Ann. tit. 33, sec. 2005. See section 128b (page 100). Disclosure is now to be made to and in a manner prescribed by the Office of the Attorney General rather than the Vermont Board of Pharmacy. Under the amended law, the disclosure must include the value, nature, and purpose of all gift expenditures according to specific categories, as well as the name of the recipient. The amendment also clarifies that annually, during the month of October, the company must disclose the name and address of the individual responsible for the company’s compliance with the gift reporting law.
The amendments also clarified the disclosure requirement exemption for the payment of reasonable compensation and reimbursement of expenses in connection with bona fide clinical trials by defining the terms “approved clinical trial,” bona fide clinical trial,” and “clinical trial.” The amendment limits the exemption for clinical trials to those trials approved by FDA or an IRB where the researcher can freely publish the research, and the research reasonably can be considered to be of interest to scientists or medical practitioners working in the particular field of inquiry.
Exemptions to the disclosure requirement were added for unrestricted grants for continuing medical education programs as well as prescription drug rebates and discounts. An unrestricted grant is “any gift, payment, subsidy, or other economic benefit to an educational institution, professional association, health care facility, or government entity which does not impose any restrictions on the use of the grant, such as favorable treatment of a certain product or an ability of the marketer to control or influence the planning, content, or execution of the education activity.”