On January 13, 2005, the Office of the Attorney General of Vermont published its Guide to Vermonts Pharmaceutical Marketer Price Disclosure Law, 33 V.S.A. 2005a, which requires pharmaceutical marketers to disclose to Vermont physicians the average wholesale prices (AWPs) of the prescription drugs that they market and the AWPs of other drugs in the same therapeutic class.

Compliance with this Guide is mandatory and will be enforced by the Vermont Attorney Generals Office, effective March 1, 2005.

The price disclosure requirements apply to pharmaceutical marketers, that is, persons who work for pharmaceutical manufacturers and engage in pharmaceutical detailing, promotional activities or other marketing of prescription drugs directly to Vermont physicians (or other persons authorized to prescribe drugs).

According to the Guide, pharmaceutical marketers who promote a prescription drug directly to prescribers in Vermont via mailings, telephone calls, e-mails, face-to-face meetings, or hand delivery of materials, must provide the required price disclosure.

However, pharmaceutical companies who promote their products in magazines, on television, or in other media are not subject to the law. Sponsorship of independent continuing medical education in Vermont and the publication of reminder communications also do not trigger the price disclosure obligations.

Notably, the law only applies to prescription drugs that are available in pill form. Drugs that are only available in liquid, aerosol, injectable, or other non-pill form are exempt from the law. Also exempt from the law are drugs marketed for use in hospitals or by patients within a health care facility such as a diagnostic, dialysis, or outpatient (or day procedure) facility.

Pharmaceutical marketers must disclose pricing information to Vermont prescribers in two forms:

• The Short Form Disclosure must be distributed directly to the prescriber to whom the drug is being promoted and must include: (1) the AWP per pill of the lowest dosage strength of the marketed drug, (2) the average AWPs per pill of the lowest dosage for generic products in the same therapeutic class as the marketed drug, and (3) the AWPs per pill of the lowest dosage of other proprietary drugs in the same therapeutic class. The manner in which the Short Form Disclosure must be furnished varies according to the type of marketing technique used and is specified in the Guide.
• The Long Form Disclosure must be published on a website, the address of which is required to be listed on the Short Form Disclosure. The Long Form Disclosure must include the AWP per pill for each dosage strength of the marketed drug, as well as the AWP per pill for each dosage strength of the other drugs in its therapeutic class, including the different dosage strengths of all generic products in the class. Companies are also required to provide detailed information about each listed drug, including, among other things, its manufacturer, UPC or NDC Code, and package size. The source of the AWPs must also be noted, as well as the date that the information was obtained from the source.

Certain disclaimers must be included on both the Short and Long Form Disclosures. The disclosure forms must use the AWPs published by one of the following sources: First Databank, Medispan (Wolters Klumer Health), or Redbook (Thomson MICROMEDEX). Additionally, for purposes of the price disclosures, therapeutic class refers to the therapeutic class listing in the 2004 American Hospital Formulary Service Pharmacologic Therapeutic Classification, published by the American Society of Health System Pharmacists.

A more detailed description of the forms and content of the required disclosures is set forth in the Guide. The Vermont Attorney General has also provided models for the Short and Long Form Disclosures as appendices to its Guide.

The Vermont Attorney General may file a civil action against a marketer for failure to comply with the Guide, and may seek penalties including injunctive relief to prevent further violations of the law, civil fines of up to $10,000 for each violation, restitution on behalf of a consumer or class of consumers, and reimbursement to the State of Vermont for the value of its services and its expenses in pursuing the action. Each violation constitutes grounds for a separate civil action.

The Guide is available here. Please contact Larri Short or Julia Tierney with any questions.