HB 373: "An Act relating to prescription drug marketing costs; and providing for an effective date."
00 HOUSE BILL NO. 373 01 "An Act relating to prescription drug marketing costs; and providing for an effective 02 date." 03 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA: 04 * Section 1. The uncodified law of the State of Alaska is amended by adding a new section 05 to read: 06 FINDINGS. The legislature finds that the reporting of marketing costs for prescription 07 drugs required by this Act will 08 (1) assist the state in its role as a purchaser of prescription drugs and as an 09 administrator of prescription drug programs; and 10 (2) enable the state to determine the scope of prescription drug marketing 11 costs and the effect of marketing on the cost, utilization, and delivery of health care services; 12 and 13 (3) further the role of the state as a guardian of the public interest. 14 * Sec. 2. AS 17 is amended by adding a new chapter to read:
01 Chapter 50. Reporting Prescription Drug Marketing Costs. 02 Sec. 17.50.010. Reporting required. A manufacturer or labeler of prescription 03 drugs dispensed in this state who employs, directs, or uses marketing representatives 04 in this state shall report the marketing costs of the manufacturer or labeler in this state 05 as required by this chapter. 06 Sec. 17.50.020. Manner of reporting. By July 1 of each year, a covered 07 manufacturer and a covered labeler shall 08 (1) file a report with the department in the form and manner 09 established by the department; and 10 (2) pay a fee set by the department to cover the department's 11 administrative costs of handling the report. 12 Sec. 17.50.030. Contents of report. The report required by AS 17.50.020 13 must include the information described under AS 17.50.040 14 (1) as the information relates to marketing activities conducted in this 15 state; and 16 (2) in a form that gives the value, nature, purpose, and recipient of the 17 expense. 18 Sec. 17.50.040. Information required. (a) The information in the report 19 required by AS 17.50.020 must include 20 (1) expenses that relate to residents of this state and that are associated 21 with the advertising, direct promotion, or other marketing of prescription drugs 22 through radio, television, magazines, newspapers, direct mail, and telephone 23 communication, except for expenses that are associated with advertising purchased for 24 a national market or a regional market other than this state that includes advertising in 25 the state; 26 (2) expenses that are associated with the advertising, direct promotion, 27 or other marketing of prescription drugs to health care providers in this state; expenses 28 under this paragraph include expenses associated with 29 (A) educational or informational programs, materials, and 30 seminars, and remuneration for promoting or participating in the programs, 31 materials, and seminars, regardless of whether the covered manufacturer or
01 covered labeler provides the sessions, materials, or seminars; 02 (B) food, entertainment, gifts, and other economic benefits 03 provided at less than market value; 04 (C) trips and travel; and 05 (D) product samples, except for samples that are provided for 06 the purpose of free distribution to patients; and 07 (3) the cost, in an aggregated form, of all employees or contractors of 08 the covered manufacturer or covered labeler who directly or indirectly engage in the 09 advertising or promotional activities listed in (1) or (2) of this subsection, including 10 any form of payment to an employee or a contractor; the cost reported under this 11 paragraph must reflect only the portion of the payment to an employee or a contractor 12 that relates to activities in this state or to recipients of the advertising or promotional 13 activities who are residents of or employed in this state. 14 (b) In this section, "health care provider" means a person authorized to 15 provide health care in this state, the person's employees in this state, a health care 16 insurer, a health plan, a pharmacy, a hospital, a nursing facility, and a clinic. 17 Sec. 17.50.050. Exceptions. A covered manufacturer or covered labeler is not 18 required to report the following expenses under AS 17.50.040: 19 (1) expenses of $25 or less; 20 (2) reasonable compensation and reimbursement of expenses in 21 connection with a bona fide clinical trial of a new vaccine, therapy, or treatment; or 22 (3) scholarships and reasonable reimbursement of expenses for 23 attending a significant educational, scientific, or policy-making conference or seminar 24 of a national medical association, a regional medical association, a specialty medical 25 association, or another professional medical association if the recipient of the 26 scholarship or reimbursement is selected by the association sponsoring the conference 27 or seminar. 28 Sec. 17.50.060. Reports by department. (a) On or before November 1 of each 29 calendar year, the department shall provide a written report to the attorney general and 30 to the legislature on the prescription drug marketing expenses information received 31 under AS 17.50.020 during the preceding fiscal year. The department shall present the
01 information in an aggregated form. 02 (b) On or before November 1 every two years, the department shall provide a 03 written report to the attorney general and the legislature that analyzes the information 04 submitted to the department during the two previous fiscal years under AS 17.50.020. 05 The department shall include in the report 06 (1) the scope of prescription drug marketing activities in the state; 07 (2) an aggregated form of the expenses reported under AS 17.50.020; 08 (3) the effect of (1) and (2) of this subsection on the cost, utilization, 09 and delivery of health care services in the state; and 10 (4) recommendations for the marketing activities of prescription drug 11 manufacturers and labelers in the state. 12 Sec. 17.50.070. Confidentiality; public information. (a) Information 13 submitted to the department under this chapter is confidential and is not a public 14 record under AS 40.25.120. 15 (b) Information compiled in an aggregated form by the department for the 16 purposes of reporting under AS 17.50.060 is a public record under AS 40.25.120, 17 except that compiled information that reveals trade information that is protected by 18 state or federal law is confidential to the extent it reveals the trade information and is 19 not a public record under AS 40.25.120. 20 Sec. 17.50.080. Penalty. A covered manufacturer or a covered labeler who 21 knowingly fails to provide a report required by this chapter is subject to a civil penalty 22 of $1,000. 23 Sec. 17.50.085. Regulations. The department shall adopt regulations under 24 AS 44.62 (Administrative Procedure Act) to implement this chapter. 25 Sec. 17.50.090. Definitions. In this chapter, unless the context requires 26 otherwise, 27 (1) "aggregated" means gathered into categories without using 28 information that reveals the identity of a specific person; 29 (2) "covered labeler" means a labeler who employs, directs, or uses 30 marketing representatives in this state; 31 (3) "covered manufacturer" means a manufacturer who employs,
01 directs, or uses marketing representatives in this state; 02 (4) "department" means the Department of Health and Social Services; 03 (5) "labeler" means a person who 04 (A) receives prescription drugs from a manufacturer or 05 wholesaler and repackages the drugs for later retail sale; and 06 (B) has a labeler code issued by the United States Food and 07 Drug Administration under 21 C.F.R. 207.20; 08 (6) "manufacturer" means a manufacturer of prescription drugs and 09 includes a subsidiary or an affiliate of a manufacturer; 10 (7) "marketing" means advertising and promotional activities. 11 * Sec. 3. The uncodified law of the State of Alaska is amended by adding a new section to 12 read: 13 TRANSITION. (a) The first report required under AS 17.50.060(a), enacted by sec. 2 14 of this Act, is due February 1, 2011. 15 (b) The first report required under AS 17.50.060(b), enacted by sec. 2 of this Act, is 16 due February 1, 2013. 17 * Sec. 4. This Act takes effect July 1, 2010.