May 22, 2008, Introduced by Reps. Valentine, Kathleen Law, Ebli, Simpson, Cushingberry, Brown, Donigan, Bieda, Miller, Tobocman, Byrum, Corriveau, Leland, Meadows, Vagnozzi, Gonzales, Hammon, Hammel, Clack, Condino, Jackson, Bennett, Gillard, Mayes, Young, Dean, Espinoza, Lemmons, Alma Smith, Johnson, Melton and Constan 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) On or before March 1, 2009 and subject to
subsection (2), each manufacturer and wholesale distributor shall
adopt a comprehensive compliance program that complies with the
publication entitled "Compliance Program Guidance for
Pharmaceutical Manufacturers" published by the OIG. A manufacturer
or wholesale distributor shall include in its comprehensive
compliance program policies for compliance with the publication
entitled "Code on Interactions with Health Care Professionals"
published by PhRMA.
(2) If the "Compliance Program Guidance for Pharmaceutical
Manufacturers" publication is revised by the OIG after the
effective date of this section, the department may by order adopt
the revisions if the new publication provides at least the same or
additional guidance to manufacturers and wholesale distributors
regarding internal controls and procedures that promote adherence
to applicable statutes, regulations, and requirements of the
federal health care programs and in evaluating and, as necessary,
refining existing compliance programs. If the "Code on Interactions
with Health Care Professionals" publication is revised by PhRMA
after the effective date of this section, the department may by
order adopt the revisions if the new publication provides at least
the same or additional guidance to manufacturers and wholesale
distributors regarding ethical interactions with prescribers that
relate to the marketing of prescription drug products. If new
guidance is adopted by the department under this subsection, the
department shall publish the new guidance and notify manufacturers
and wholesale distributors licensed under this article of the new
guidance. A manufacturer or wholesale distributor shall make
conforming changes to its comprehensive compliance program on or
before the expiration of 6 months after notice by the department is
given under this subsection.
(3) Each manufacturer and wholesale distributor shall include
in its comprehensive compliance program all of the following:
(a) Limits on gifts or incentives provided to prescribers, in
accordance with this section.
(b) A specific annual dollar limit on gifts, promotional
materials, or items or activities that the manufacturer or
wholesale distributor may give or otherwise provide to an
individual prescriber in accordance with the "Compliance Program
Guidance for Pharmaceutical Manufacturers", with the "Code on
Interactions with Health Care Professionals", and with any
revisions to those publications adopted under subsection (2).
(4) Notwithstanding subsection (3), drug samples given to
prescribers intended for free distribution to patients, financial
support for continuing medical education forums, and financial
support for health educational scholarships are exempt from any
limits if that support is provided in a manner that conforms to the
"Compliance Program Guidance for Pharmaceutical Manufacturers",
with the "Code on Interactions with Health Care Professionals", and
with any revisions to those publications adopted under subsection
(2).
(5) Payments made for legitimate professional services
provided by a prescriber, including, but not limited to,
consulting, are exempt from any limits as long as the payment does
not exceed the fair market value of the services provided and
payments are made in a manner that conforms to the "Compliance
Program Guidance for Pharmaceutical Manufacturers", with the "Code
on Interactions with Health Care Professionals", and with any
revisions to those publications adopted under subsection (2).
(6) A manufacturer or wholesale distributor shall annually
report to the department that it is in compliance with its
comprehensive compliance program and this section. The manufacturer
or wholesale distributor shall report on a form and in the manner
prescribed by the department. The manufacturer or wholesale
distributor shall make its comprehensive compliance program and its
annual report of compliance with the program available to the
public on the manufacturer's or wholesale distributor's website and
shall also provide a toll-free telephone number where a copy or
copies of the comprehensive compliance program and its annual
report of compliance with the program may be obtained.
(7) As used in this section:
(a) "OIG" means the office of inspector general of the United
States department of health and human services.
(b) "PhRMA" means the pharmaceutical research and
manufacturers of America.
(8) This section takes effect January 1, 2009.
Enacting section 1. This amendatory act does not take effect
unless Senate Bill No.____ or House Bill No. 6159(request no.
07255'08) of the 94th Legislature is enacted into law.