Prescribed Products

This page covers the following topics:

Litigation

Prescribed Products Disclosures - Annual Reports

Samples of Prescribed Products

Implementation of the Pharmaceutical Marketer Price Disclosure Law

Other Resources

The Attorney General is responsible for enforcing Vermont’s consumer protection and disclosure laws concerning prescribed products. “Prescribed products” refers to:

pharmaceuticals (chemical compounds, e.g. prescribed pills),

biological products (derived from living material e.g. vaccines, blood derivatives), and

medical devices (e.g. surgical tools, artificial knees or hips), as well as any combination of these products (for example, a stent that releases drugs).

The Vermont Attorney General Office has placed special emphasis on ensuring that prescribed products, especially prescription drugs, are sold to consumers in a competitive and fair manner.

Litigation

The Attorney General’s Office has investigated and prosecuted allegations of anticompetitive conduct and violations of consumer protection laws by pharmaceutical and medical device manufacturers, including, for example:

illegal agreements between pharmaceutical manufacturers to keep lower cost generic drugs off the market

illegal agreements between pharmaceutical manufacturers, and other practices by companies to keep prices artificially inflated deceptive claims by pharmaceutical manufacturers about their products, or about their competitors' products.

illegal marketing by manufacturers of off-label uses (not approved by FDA) of their products

failure to disclose potentially adverse side effects of pharmaceutical products

deceptive promotional and marketing practices by manufacturers, such as ghost-writing articles about the efficacy of products, or suppressing unfavorable results of clinical trials.

Prescribed Products Disclosures - Annual Reports

The Vermont Attorney General is responsible for collecting and reporting on the marketing expenditures paid by manufacturers of pharmaceuticals, biological products and medical devices to Vermont health care providers. The office has been collecting data and publishing reports regarding pharmaceutical marketing since July 2002. Manufacturers must now also report expenditures for the marketing of biological products and medical devices, starting with the year July 1, 2009 through June 30, 2010; the Attorney General’s Office will release its report on those expenditures in early 2011.

Prescribed Products Annual Reports, July 1, 2002 to present.

Public Data on which those reports are based.

Prescription Confidentiality/Pharmaceutical Data Mining

Effective July 1, 2009, Vermont law restricts the use of prescriber-identifiable data for marketing prescription drugs. The governing statute is 18 V.S.A. § 4631: http://www.leg.state.vt.us/statutes/fullsection.cfm?Title=18&Chapter=091&Section=04631 The law prohibits the use of prescriber-identifiable data from prescription drug records for marketing prescription drugs, unless the prescriber consents.

Attached here are a short FAQ about the law and a copy of the April 2009 decision from the United States District Court upholding the law. The District Court decision is pending on appeal at the Second Circuit Court of Appeals in New York.

The Medical Practice Board, part of the Department of Health, maintains a list of prescribers who – as permitted by the law – have consented to the use of their data for marketing prescription drugs. The list is posted on the Board’s website: http://healthvermont.gov/hc/med_board/application.aspx

Health care professionals who want to consent or revoke consent should contact, as appropriate for the profession, either the Medical Practice Board or the Secretary of State’s Office of Professional Regulation.

Samples of Prescribed Products

Letter to Vermont Health Care Providers re: Obligation of Manufacturers of Prescribed Products (not of HCPs) to Report Distribution of Samples to Vermont HCPs - 09/24/2010

As directed by the Legislature in 2009, the Attorney General conducted an inquiry into the advisability of requiring disclosure of manufacturers’ distribution of free samples of prescribed products. The Attorney General’s report was issued on January 15, 2010.

Report of the Vermont Attorney General on the Advisability of Requiring Disclosure of Free Samples Distributed by Manufacturers of Prescribed Products to Vermont Health Care Providers

Audio Files of Testimony

Written Submissions

Pharmaceutical Marketer Price Disclosure Law

Vermont's Pharmaceutical Marketer Price Disclosure law, 18 V.S.A. § 4633, requires pharmaceutical marketers to provide doctors with comparative price information, so that doctors can take cost into consideration when prescribing drugs within a therapeutic class. The Vermont Attorney General has issued a Guide on how to comply with the law, model forms (short form and long form), and Frequently Asked Questions.

Other Resources

State Attorneys General and Pharmaceuticals: Writing a New Prescription to Curtail Drug Costs - December, 2007
2005 NAAG Presidential Report: Addressing the Cost and Benefits of Prescription Drugs - July 7, 2005