PRINTER'S NO. 2272
No. 1711 Session of 2007
INTRODUCED BY J. WHITE, BELFANTI, DeLUCA, JOSEPHS, KORTZ,
MAHONEY, MELIO, PETRONE, SCHRODER, SOLOBAY AND SURRA,
JULY 9, 2007
REFERRED TO COMMITTEE ON CONSUMER AFFAIRS, JULY 9, 2007
AN ACT
1 Requiring pharmaceutical manufacturing companies to disclose
2 certain information to the Attorney General; providing for
3 the powers of the Office of Attorney General; and imposing
4 penalties.
5 The General Assembly of the Commonwealth of Pennsylvania
6 hereby enacts as follows:
7 Section 1. Short title.
8 This act shall be known and may be cited as the
9 Pharmaceutical Marketing Disclosure Act.
10 Section 2. Definitions.
11 The following words and phrases when used in this act shall
12 have the meanings given to them in this section unless the
13 context clearly indicates otherwise:
14 "Approved clinical trial." A clinical trial that has been
15 approved by the Food and Drug Administration or has been
16 approved by a duly constituted institutional review board after
17 reviewing and evaluating it in accordance with the human subject
18 protection standards set forth in 21 C.F.R. Part 50 (relating to
1 protection of human subjects), 45 C.F.R. Part 46 (relating to
2 protection of human subjects) or an equivalent set of standards
3 of another Federal agency.
4 "Bona fide clinical trial." An approved clinical trial that
5 constitutes research, as that term is defined in 45 C.F.R. §
6 46.102 (relating to definitions), when the results of the
7 research can be published freely by the investigator and
8 reasonably can be considered to be of interest to scientists or
9 medical practitioners working in the particular field of
10 inquiry.
11 "Clinical trial." A study that assesses:
12 (1) the safety or efficacy of drugs administered alone
13 or in combination with other drugs or other therapies; or
14 (2) the relative safety or efficacy of drugs in
15 comparison with other drugs or other therapies.
16 "Pharmaceutical manufacturing company." Either of the
17 following:
18 (1) An entity engaged in the production, preparation,
19 propagation, compounding, conversion or processing of
20 prescription drugs, either directly or indirectly by
21 extraction from substances of natural origin or independently
22 by means of chemical synthesis or by a combination of
23 extraction and chemical synthesis.
24 (2) An entity engaged in the packaging, repackaging,
25 labeling, relabeling or distribution of prescription drugs.
26 The term does not include a wholesale drug distributor or
27 licensed pharmacist.
28 "Pharmaceutical marketer." A person who, while employed by
29 or under contract to represent a pharmaceutical manufacturing
30 company, engages in pharmaceutical detailing, promotional
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1 activities or other marketing of prescription drugs in this
2 Commonwealth to any physician, hospital, nursing home,
3 pharmacist, health benefit plan administrator or any other
4 person authorized to prescribe, dispense or purchase
5 prescription drugs. The term does not include a wholesale drug
6 distributor or the distributor's representative that promotes or
7 otherwise markets the services of the wholesale drug distributor
8 in connection with a prescription drug.
9 "Unrestricted grant." A gift, payment, subsidy or other
10 economic benefit to an educational institution, professional
11 association, health care facility or governmental entity that
12 does not impose any restrictions on the use of the grant,
13 including, but not limited to, favorable treatment of a certain
14 product or an ability of the marketer to control or influence
15 the planning, content or execution of the educational activity.
16 Section 3. Annual report to Attorney General.
17 (a) Duty of report.--On or before January 1 of each year, a
18 pharmaceutical manufacturing company shall disclose to the
19 Office of Attorney General the value, nature and purpose of any
20 gift, fee, payment, subsidy or other economic benefit provided
21 in connection with detailing, promotional or other marketing
22 activities by the company, directly or through its
23 pharmaceutical marketers, to any physician, hospital, nursing
24 home, pharmacist, health benefit plan administrator or any other
25 person in this Commonwealth authorized to prescribe, dispense or
26 purchase prescription drugs in this Commonwealth.
27 (b) Contents of disclosure.--Disclosure shall be made on a
28 form and in a manner prescribed by the Office of Attorney
29 General. Disclosure shall include the name and address of the
30 recipient and shall require pharmaceutical manufacturing
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1 companies to report the value, nature and purpose of all gift
2 expenditures.
3 (c) Attorney General report to General Assembly and
4 Governor.--The Office of Attorney General shall report annually
5 on the disclosures made under this act to the General Assembly
6 and the Governor on or before April 1.
7 (d) Report of compliance representatives.--Annually on
8 October 1, each company subject to the provisions of this
9 section shall also disclose to the Office of Attorney General
10 the name and address of the individual responsible for the
11 company's compliance with the provisions of this act.
12 (e) Exemptions.--The following shall be exempt from
13 disclosure under this act:
14 (1) Free samples of prescription drugs intended to be
15 distributed to patients.
16 (2) The payment of reasonable compensation and
17 reimbursement of expenses in connection with bona fide
18 clinical trials.
19 (3) Any gift, fee, payment, subsidy or other economic
20 benefit the value of which is less than $100.
21 (4) Scholarships or other support for medical students,
22 residents and fellows to attend a significant educational,
23 scientific or policymaking conference of a national, regional
24 or medical specialty or other professional association, if
25 the recipient of the scholarship or other support is selected
26 by the association.
27 (5) Unrestricted grants for continuing medical education
28 programs.
29 (6) Prescription drug rebates and discounts.
30 (f) Enforcement.--The Attorney General may bring an action
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1 for injunctive relief, costs and attorney fees, and impose on a
2 pharmaceutical manufacturing company that fails to disclose as
3 required by subsection (a) a civil penalty of no more than
4 $10,000 per violation. Each unlawful failure to disclose shall
5 constitute a separate violation.
6 Section 4. Effective date.
7 This act shall take effect in 90 days.
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