HOUSE BILL No. 6158

 

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.