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H.532

Introduced by   Representatives Martin of Springfield, Audette of South Burlington, Bohi of Hartford, Botzow of Pownal, Chen of Mendon, Connell of Warren, Darrow of Dummerston, Donovan of Burlington, Dostis of Waterbury, Emmons of Springfield, Fisher of Lincoln, French of Randolph, Head of South Burlington, Heath of Westford, Hummel of Underhill, Jewett of Ripton, Keenan of St. Albans City, Keogh of Burlington, Kitzmiller of Montpelier, Klein of East Montpelier, Larson of Burlington, Lippert of Hinesburg, Maier of Middlebury, Marek of Newfane, Masland of Thetford, McCullough of Williston, Milkey of Brattleboro, Miller of Shaftsbury, Nease of Johnson, Nitka of Ludlow, Obuchowski of Rockingham, Partridge of Windham, Perry of Richford, Reese of Pomfret, Seibert of Norwich, Shand of Weathersfield, Sharpe of Bristol, Smith of Morristown, Symington of Jericho and Tracy of Burlington

Referred to Committee on

Date:

Subject:  Health; prescription drug; marketing cost; disclosure

Statement of purpose:  This bill proposes to require public disclosure of prescription drug marketing costs by pharmaceutical manufacturers.

AN ACT RELATING TO THE DISCLOSURE OF PRESCRIPTION DRUG MARKETING COSTS

It is hereby enacted by the General Assembly of the State of Vermont:

Sec. 1.  33 V.S.A. § 2005 is amended to read:

§ 2005.  PHARMACEUTICAL MARKETERS

(a)(1)  Annually on or before January 1 of each year, every pharmaceutical manufacturing company shall disclose to the Vermont board of pharmacy the:

(A)  the value, nature and purpose of any gift, fee, payment, subsidy, or other economic benefit provided in connection with detailing, promotional or other marketing activities by the company, directly or through its pharmaceutical marketers, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, or any other person in Vermont authorized to prescribe, dispense, or purchase prescription drugs in this state;

(B)  the expenses associated with any gift, fee, payment, subsidy, or other economic benefit provided in connection with detailing, promotional or other marketing activities by the company, directly or through its pharmaceutical marketers, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, or any other person in Vermont authorized to prescribe, dispense, or purchase prescription drugs in this state;

(C)  the expenses associated with advertising, marketing, and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail, and telephone in connection with detailing, promotional, or other marketing activities by the company, directly or through its pharmaceutical marketers, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, or any other person in Vermont authorized to prescribe, dispense, or purchase prescription drugs in this state;

(D)  the expenses associated with educational or informational programs, materials, and seminars and remuneration for promoting or participating in educational or informational sessions, regardless of whether the manufacturer or labeler provides the educational or informational sessions or materials provided to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, medical student, resident, fellow, or any other person in Vermont authorized to prescribe, dispense, or purchase prescription drugs in this state; and

(E)  expenses associated with advertising, marketing, and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail, and telephone as they pertain to residents of this state.

(2)  Disclosure shall be made on a form and in a manner prescribed by the board. Initial disclosure shall be made on or before January 1, 2004 for the 12-month period ending June 30, 2003.  The board shall provide to the office of the attorney general complete access to the information required to be disclosed under this subsection.  The office of the attorney general shall report annually on the disclosures made under this section to the general assembly and the governor on or before March 1.

(2)(3)  Each company subject to the provisions of this section shall also disclose to the board, on or before October 1, 2002 and annually thereafter, the name and address of the individual responsible for the company’s compliance with the provisions of this section.

(3)(4)  The Vermont board of pharmacy and the office of the attorney general shall keep confidential all trade secret information, as defined by subdivision 317(b)(9) of Title 1.  The disclosure form prescribed by the board shall permit the company to identify any information that is a trade secret.

(4)(5)  The following shall be exempt from disclosure:

(A)  free samples of prescription drugs intended to be distributed to patients;

(B)  the payment of reasonable compensation and reimbursement of expenses in connection with bona fide clinical trials.  As used in this subdivision, “clinical trial” means an approved clinical trial conducted in connection with a research study designed to answer specific questions about vaccines, new therapies or new ways of using known treatments; and

(C)  any gift, fee, payment, subsidy, or other economic benefit the value of which is less than $25.00; and

(D)  scholarship or other support for medical students, residents and fellows to attend a significant educational, scientific or policy-making conference of a national, regional, or specialty medical or other professional association if the recipient of the scholarship or other support is selected by the association.

(b)  The attorney general may bring an action in Washington superior court for injunctive relief, costs, and attorneys fees, and to impose on a pharmaceutical manufacturing company that fails to disclose as required by subsection (a) of this section a civil penalty of no more than $10,000.00 per violation.  Each unlawful failure to disclose shall constitute a separate violation.  The attorney general may issue civil investigative demands and otherwise investigate alleged violations of subsection (a) of this section pursuant to 9 V.S.A. § 2460.



Published by:

The Vermont General Assembly
115 State Street
Montpelier, Vermont


www.leg.state.vt.us