Requires manufacturers and labelers of prescription drugs dispensed in this state which engage in marketing activities in the state to annually report marketing expenses to the department of health; imposes a $10,000 civil fine for failure to report.
STATE OF NEW YORK
________________________________________________________________________
5777
2009-2010 Regular Sessions
IN ASSEMBLY
February 20, 2009
___________
Introduced by M. of A. BRODSKY, SPANO -- read once and referred to the
Committee on Health
AN ACT to amend the public health law, in relation to requiring the
manufacturer or labeler of each prescription drug to annually report
the marketing costs of such drug to the department of health
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Legislative intent. The legislature hereby finds and
2 declares that the price of prescription drugs in this state and across
3 the nation has been increasing at an alarming rate over the past decade.
4 Prescription drug costs are increasing at a faster rate than any other
5 component of health care and are driving the increase in overall health
6 care cost. As is apparent by the ubiquitous nature of the marketing and
7 public information campaigns relating to prescription drugs, pharmaceu-
8 tical manufacturers put a great deal of resources into marketing their
9 products. This has been especially true since the 1997 relaxation of
10 federal laws relating to prescription drug advertising. It is in the
11 interest of assisting this state in its role as a purchaser of
12 prescription drugs and administrator of prescription drug programs, to
13 enable the state to determine the scope of prescription drug marketing
14 costs and their effect on the cost, utilization and delivery of health
15 care services, and thus further the role of this state as guardian of
16 the public interest.
17 § 2. Section 206 of the public health law is amended by adding a new
18 subdivision 26 to read as follows:
19 26. The commissioner is authorized and directed to require manufactur-
20 ers or labelers of prescription drugs, which dispense such drugs in this
21 state and which employ, direct or utilize marketing representatives in
22 the state, to report the marketing costs of each of its prescription
23 drugs dispensed in this state.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD08592-01-9
A. 5777 2
1 (a) Definitions. As used in this subdivision, unless the context
2 clearly indicates otherwise, the following terms shall have the follow-
3 ing meanings:
4 (i) "Labeler" means any person or entity, having a labeler code from
5 the federal Food and Drug Administration, that receives a prescription
6 drug from the manufacturer or a wholesaler of such drug, and repackages
7 such drug to be dispensed in this state.
8 (ii) "Manufacturer" means a manufacturer of prescription drugs
9 dispensed in this state, and shall include the subsidiary or affiliate
10 of such manufacturer.
11 (iii) "Marketing" means advertising and promotional activities for
12 prescription drugs dispensed in this state including, but not limited
13 to, those activities described in paragraph (b) of this subdivision.
14 (b) Manner of reporting. On or before July first each year every
15 manufacturer and labeler shall file a report with the department on its
16 marketing activities conducted in this state. Such report shall be
17 submitted in such form and manner, and include the payment of such a fee
18 as shall be determined by the commissioner. Each such report shall
19 include the value, nature, purpose and recipient of marketing expenses
20 including, but not limited to:
21 (i) all expenses associated with advertising, marketing and direct
22 promotion of prescription drugs through radio, television, magazines,
23 newspapers, direct mail and telephone communications as they pertain to
24 residents of this state;
25 (ii) with regard to all providers of healthcare services regulated by
26 the department under the provisions of article twenty-eight, thirty-six
27 or forty-four of this chapter, including health maintenance organiza-
28 tions established pursuant to article forty-three of the insurance law,
29 the following information:
30 (A) all expenses associated with educational or informational
31 programs, materials and seminars, and remuneration for promoting or
32 participating in educational or informational sessions, regardless of
33 whether the manufacturer or labeler provides the educational or informa-
34 tional sessions or materials,
35 (B) all expenses associated with food, entertainment and gifts valued
36 at more than seventy-five dollars, and anything provided to a health
37 care professional for less than market value,
38 (C) all expenses associated with trips and travel, and
39 (D) all expenses associated with product samples, except for samples
40 that will be distributed free of charge to patients; and
41 (iii) the aggregate cost of all employees and contractors of the
42 manufacturer or labeler who directly or indirectly engage in the adver-
43 tising or promotional activities listed in subparagraphs (i) and (ii) of
44 this paragraph, including all forms of payment to such employees and
45 contractors. The cost reported pursuant to this subparagraph shall
46 reflect only that portion of payment to employees and contractors that
47 pertains to activities within this state or to recipients of the adver-
48 tising or promotional activities who are residents of or are employed in
49 this state.
50 (c) Exceptions. The following marketing expenses shall not be subject
51 to the reporting requirements of this subdivision:
52 (i) expenses of seventy-five dollars or less;
53 (ii) reasonable compensation and reimbursement for expenses in
54 connection with a bona fide clinical trial of a new vaccine, therapy or
55 treatment; and
A. 5777 3
1 (iii) scholarships and reimbursement of expenses for attending a
2 significant educational, scientific or policy-making conference or semi-
3 nar of a national, regional or specialty medical or other professional
4 association if the recipient of the scholarship is chosen by the associ-
5 ation sponsoring the conference or seminar.
6 (d) Department reports. Annually on or before November thirtieth, the
7 department shall submit a report, providing information in aggregate
8 form, on prescription drug marketing expenses to the governor, temporary
9 president of the senate and speaker of the assembly. On or before Janu-
10 ary first, two thousand ten and every two years thereafter, the depart-
11 ment shall provide a report to the governor, temporary president of the
12 senate and speaker of the assembly, providing information in aggregate
13 form, containing an analysis of the data submitted to the department,
14 including the scope of prescription drug marketing activities and
15 expenses and their effect on the cost, utilization and delivery of
16 health care services and any recommendations with regard to marketing
17 activities of prescription drug manufacturers and labelers.
18 (e) Confidentiality; public information. Notwithstanding any provision
19 of law to the contrary, all information submitted to the department
20 pursuant to this subdivision shall be confidential and not a public
21 record as defined in section eighty-six of the public officers law. Data
22 compiled in aggregate form by the department for the purposes of report-
23 ing required by this subdivision shall be a public record as defined in
24 section eighty-six of the public officers law, as long as it does not
25 reveal trade information that is protected by state or federal law.
26 (f) Violations. Any person who violates any provision of this subdivi-
27 sion shall be liable to the people of the state for a civil penalty of
28 ten thousand dollars, plus court costs and attorneys' fees, which shall
29 be enforced pursuant to title two of this article.
30 (g) Rules. Any and all rules and regulations necessary to implement
31 the provisions of this subdivision shall be promulgated by the commis-
32 sioner.
33 § 3. This act shall take effect on the one hundred eightieth day after
34 it shall have become a law. Effective immediately, any rules and regu-
35 lations necessary to implement the provisions of this act on its effec-
36 tive date are authorized to be made on or before such effective date.
