Bill Text: AZ SB1237 | 2010 | Forty-ninth Legislature 2nd Regular | Introduced
Bill Title: Prescription marketing costs; full disclosure
Spectrum: Partisan Bill (Democrat 10-0)
Status: (Introduced - Dead) 2010-01-28 - Referred to Senate CED Committee [SB1237 Detail]
Download: Arizona-2010-SB1237-Introduced.html
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REFERENCE TITLE: prescription marketing costs; full disclosure |
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State of Arizona Senate Forty-ninth Legislature Second Regular Session 2010
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SB 1237 |
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Introduced by Senators Burton Cahill, Aguirre: Aboud, Alvarez, Garcia, Landrum Taylor, Lopez, McCune Davis; Representatives Ableser, Lopes
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AN ACT
Amending title 36, Arizona Revised Statutes, by adding chapter 11; relating to prescription medication marketing costs.
(TEXT OF BILL BEGINS ON NEXT PAGE)
Be it enacted by the Legislature of the State of Arizona:
Section 1. Title 36, Arizona Revised Statutes, is amended by adding chapter 11, to read:
CHAPTER 11
PRESCRIPTION MEDICATION MARKETING COSTS
ARTICLE 1. GENERAL PROVISIONS
36-1301. Definitions
In this article, unless the context otherwise requires:
1. "Administration" means the Arizona health care cost containment system administration.
2. "Director" means the director of the Arizona health care cost containment system administration.
3. "Labeler" means an entity or person that receives prescription drugs from a manufacturer or wholesaler, that repackages those drugs for later retail sale and that has a labeler code from the United States food and drug administration under 21 Code of Federal Regulations section 207.20.
4. "Manufacturer" means a manufacturer of prescription drugs and includes a subsidiary or affiliate of a manufacturer.
36-1302. Marketing costs; reporting requirements; fee; civil penalty
A. Beginning February 1, 2011, each manufacturer or labeler of prescription drugs dispensed in this state that employs, directs or uses marketing representatives in this state must submit an annual report of marketing costs for prescription drugs in this state to the administration in the form and manner prescribed by the director. The report must be accompanied by a fee as prescribed by the administration by rule.
B. The annual report must include the following information for the preceding calendar year, beginning with calendar year 2010, as it pertains to marketing activities conducted in this state, and must be in a form that provides the value, nature, purpose and recipient of the expense:
1. All expenses associated with advertising, marketing and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail and telephone communications as they pertain to residents of this state, except for expenses associated with advertising purchased for a regional or national market that includes advertising in this state.
2. With regard to all persons and entities licensed to provide health care in this state, including health care professionals and persons employed by them, insurance carriers, health plans and benefits managers, pharmacies and health care institutions licensed pursuant to this title:
(a) All 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.
(b) All expenses associated with food, entertainment and gifts that are valued at more than twenty-five dollars and anything provided to a health care professional for less than market value.
(c) All expenses associated with trips and travel.
(d) All expenses associated with product samples, except for samples that will be distributed free of charge to patients.
3. The aggregate cost of all employees or contractors of the manufacturer or labeler who directly or indirectly engage in the advertising or promotional activities listed in paragraph 2 of this subsection, including all forms of payment to those employees. The cost reported under this paragraph must reflect only that portion of payment to employees or contractors that pertains to activities in this state or to recipients of the advertising or promotional activities who are residents of or are employed in this state.
C. The following marketing expenses are not subject to the requirements of this section:
1. Expenses of less than twenty-five dollars.
2. Reasonable compensation and reimbursement for expenses in connection with a bona fide clinical trial of a new vaccine, therapy or treatment.
3. Scholarships and reimbursement of expenses for attending a significant educational, scientific or policymaking conference or seminar of a national, regional or specialty medical or other professional association if the recipient of the scholarship is chosen by the association sponsoring the conference or seminar.
D. Beginning October 1, 2011, the administration shall submit an annual report that provides information in an aggregate form on prescription drug marketing expenses to the governor, the speaker of the house of representatives, the president of the senate and the attorney general. The administration shall provide a copy of each report to the secretary of state.
E. Beginning October 1, 2012, the administration shall submit a report every two years to the governor, the speaker of the house of representatives, the president of the senate and the attorney general that contains an analysis of the data submitted to the administration, including the scope of prescription drug marketing activities and expenses and their effect on the cost, utilization and delivery of health care services. The report shall include any recommendations with regard to marketing activities of prescription drug manufacturers and labelers. The administration shall provide a copy of each report to the secretary of state.
F. Notwithstanding any provision of law to the contrary, information submitted to the administration pursuant to this section is confidential and is not subject to public inspection. The administration may disclose information to a contractor that provides services to the administration pursuant to this section, but that disclosure does not change the confidential status of the information. Data compiled in aggregate form by the administration for the purposes of reporting required by this section is open to public inspection if it does not reveal trade information that is protected by state or federal law.
G. A manufacturer or labeler that fails to provide a report as required pursuant to this section is subject to a civil penalty of one thousand dollars for each violation in addition to costs incurred to enforce this section. This section may be enforced in a civil action brought by the attorney general.
H. The administration shall adopt rules to implement this section.
