October 31, 2007, Introduced by Reps. Simpson, Brown, Byrum, McDowell, Bieda, Donigan, Vagnozzi, Valentine, Corriveau, Polidori, Leland, Hopgood, Dean, Miller, Alma Smith, Ebli, Lemmons, Wojno, Kathleen Law, Constan, Jackson, Accavitti, Hammel and Scott and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
(MCL 333.1101 to 333.25211) by adding section 17790.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 17790. (1) A manufacturer, including any employee or
agent of the manufacturer, shall keep a detailed record of the
value, nature, and purpose of any gifts, fees, payments, subsidies,
or other economic benefits provided in connection with
pharmaceutical detailing, marketing, advertising, or other
promotional activities directed to a pharmacist or dispensing
prescriber or his or her designee.
(2) By December 31, 2008 and each year thereafter, a
manufacturer shall submit a written report to the department that
discloses the value, nature, and purpose of any gifts, fees,
payments, subsidies, or other economic benefits provided in
connection with pharmaceutical detailing, marketing, advertising,
or other promotional activities directed to a pharmacist or
dispensing prescriber, or his or her designee. The report shall be
on a form and in a manner as prescribed by the department. The
department shall assess a filing fee for this report that covers
the department's administrative cost of maintaining these reports.
On or before March 31, 2009, and each year thereafter, the
department shall report to the legislature and the governor on the
disclosures made under this section. Each manufacturer shall also
disclose to the department, on or before September 31, 2008, and
annually thereafter, the name and address of the individual
responsible for the manufacturer's compliance with the provisions
of this section.
(3) The department shall make the reports submitted pursuant
to this section available to the public on the department's
website.
(4) Each of the following is exempt from disclosure under this
section:
(a) Free samples or complementary starter doses of
prescription drugs that are intended to be distributed to patients.
(b) Payment of reasonable compensation and reimbursement of
expenses incurred 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.
(c) Any gift, fee, payment, subsidy, or other economic benefit
the value of which is less than $25.00.
(5) A manufacturer who neglects or refuses to file a report
under this section is subject to an administrative fine of not more
than $10,000.00. A manufacturer who intentionally provides a false
report is subject to an administrative fine of not more than
$500,000.00.
Enacting section 1. This amendatory act does not take effect
unless all of the following bills of the 94th Legislature are
enacted into law:
(a) Senate Bill No.____ or House Bill No. 5389(request no.
02306'07).
(b) Senate Bill No.____ or House Bill No. 5387(request no.
02307'07).