H. B. 4637
(By Delegates Fleischauer, Hatfield, Mahan,
Hrutkay, Fragale, Susman and Brown)
[Introduced February 26, 2004; referred to the
Committee on the Judiciary.]
A BILL to amend the code of West Virginia, 1931, as amended by
adding thereto a new article, designated §16-42-1, §16-42-2,
§16-42-3 and §16-42-4, all relating to establishing the "West
Virginia Prescription Drug Ethical Marketing Act."
Be it enacted by the Legislature of West Virginia:
That the code of West Virginia, 1931, as amended, be amended
by adding thereto a new article, designated §16-42-1, §16-42-2,
§16-42-3 and §16-42-4, all to read as follows:
ARTICLE 42. WEST VIRGINIA PRESCRIPTION DRUG ETHICAL MARKETING ACT.
§16-42-1. Short title.
This article may be cited as the "West Virginia Prescription
Drug Ethical Marketing Act."
§16-42-2. Findings and purpose.
(a)
Findings. -- The Legislature finds that:
(1) Prescription drug spending is the fastest growing
component of health care spending in the United States.
(2) Drug manufacturers' marketing to doctors, called
"detailing" is causing doctors to prescribe the most expensive
medicines, even when less expensive drugs are as effective or
safer.
(3) Gifts from prescription drug detailers to doctors play a
major role in persuading doctors to change the drugs they
prescribe.
(b)
Purpose. -- This law is enacted to lower prescription drug
costs for individuals, businesses and the state, and to protect the
health of residents, by deterring the practice of unethical
gift-giving by drug manufacturers.
§16-42-3. Prescription drug ethical marketing.
(a)
Definitions. -- In this section:
(1) "Pharmaceutical marketer" means a person who, while
employed by or under contact to represent a pharmaceutical
manufacturing company, engages in pharmaceutical detailing
promotional activities, or other marketing of prescription drugs in
this state to any physician, hospital, nursing home, pharmacist,
health benefit plan administrator, or any other person authorized
to prescribe, dispense or purchase prescription drugs. The term
does not include a wholesale drug distributor or the distributor's
representative who promotes or otherwise markets the services of
the wholesale drug distributor in connection with a prescription
drug.
(2) "Pharmaceutical manufacturing company" means any entity
which is engaged in the production, preparation, propagation,
compounding, conversion, or processing of prescription drugs,
either directly or indirectly by extraction from substances of
natural origin, or independently by means of chemical synthesis, or
by a combination of extraction and chemical synthesis, or any
entity engaged in the packaging, repackaging, labeling, relabeling,
or distribution of prescription drugs. The term does not include
a wholesale drug distributor or pharmacist licensed under article
five, chapter thirty of this code.
(3) "Secretary" means the secretary of the department of
health and human resources or the secretary's designee.
(4) "Manufacturer" means a manufacturer of prescription drugs
as defined in 42 U.S.C. §1396r8(k)(5), including a subsidiary or
affiliate of a manufacturer.
(5) "Labeler" means an entity or person that receives
prescription drugs from a manufacturer or wholesaler and repackages
those drugs for later retail sale, and that has a labeler code from
the food and drug administration under 21 C.F.R. 207.20 (1999).
(b)
Disclosure of marketing practices. --
(1) On or before the first day of October of each year, every
manufacturer and labeler that sells prescription drugs in the state
shall disclose to the secretary the name and address of the
individual responsible for the company's compliance with the provisions of this section.
(2) On or before the first day of January of each year, every
manufacturer and labeler that sells prescription drugs in the state
shall disclose to the secretary 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 West
Virginia authorized to prescribe, dispense, or purchase
prescription drugs in this state. Disclosure shall cover the prior
period of the first day of July to the thirtieth day of June.
Disclosure shall be made on a form and in a manner prescribed by
the secretary.
(3) On or before the first day of March of each year, the
secretary shall report to the Legislature and the governor on the
disclosures made under this section.
(4) The following are exempt from disclosure:
(i) Any gift, fee, payment, subsidy or other economic benefit
the value of which is less than twenty-five dollars.
(ii) Free samples of prescription drugs to be distributed to
patients.
(iii) 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.
(iv) 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.
(c)
Administration and enforcement. --
(1) The secretary shall enforce this article. The secretary
is authorized to propose Legislative rules in accordance with
article three, chapter twenty-nine-a of this code to implement and
administer compliance.
(2) The secretary may bring an action in court for injunctive
relief, costs and attorneys fees, and to impose on a pharmaceutical
manufacturing company that fails to disclose as required by this
section a civil penalty of up to ten thousand dollars per
violation. Each unlawful failure to disclose shall constitute a
separate violation.
§16-42-4. Effective date.
This article is effective on the first day of July, two
thousand four. Initial disclosure to the secretary shall be made on or before the first day of January, two thousand six.
NOTE: The purpose of this bill is to promote lower
prescription drug costs by requiring drug manufacturers and
labelers to report to the Secretary of Health and Human Resources
gifts, fees, payment, subsidies or other economic benefits of more
than $25 in value provided to physicians, hospitals, nursing homes,
pharmacists, health benefit plan administrators and others as part
of drug promotional or marketing activities. The Secretary is
authorized to seek injunctive relief, to recover litigation costs
including legal fees, and to impose civil money penalties.
The article is new; therefore, strike-throughs and
underscoring have been omitted.
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