HB 5941

HOUSE BILL NO. 5941
A bill to require drug manufacturers to report certain
information to this state; to provide for the powers and duties of certain
state governmental officers and entities; to allow for the promulgation of
rules; and to prescribe civil sanctions.
the people of the state of michigan enact:
Sec. 1. This act may be
cited as the "drug manufacturer data reporting act".
Sec. 3. As used in this
act:
(a) "Department" means the department of insurance
and financial services.
(b) "Director" means the director of the department
or the director's designee.
(c) "Drug manufacturer" means a manufacturer as that
term is defined in section 17706 of the public health code, 1978 PA 368, MCL
333.17706.
(d) "Prescription
drug" means that term as defined in section 17708 of the public health
code, 1978 PA 368, MCL 333.17708.
(e) "Wholesale
acquisition cost" means that term as defined in 42
USC 1395w-3a(c)(6)(B) or any other list price for a prescription drug that is
contained within a list of prescription drugs and prices maintained by a drug
manufacturer.
Sec. 7. (1) A drug
manufacturer shall submit a report to the department
and to the house and senate fiscal agencies not later than 90 days before increasing
the wholesale acquisition cost of a prescription drug that
exceeds $40.00 for the cost of 1 course of treatment by 5% or more in a
given year or by 15% or more over a 3-year
period. The report must be submitted in a form and
manner required by the department and include all of the following
information:
(a) The name of the prescription drug.
(b) Whether the prescription drug is a brand name or generic
prescription drug or a biological drug product or
biosimilar drug product.
(c) The effective date and the percentage of the change in the
wholesale acquisition cost.
(d) Aggregate, company-level research
and development costs for the previous calendar year.
(e) The amount spent on researching
and developing the prescription drug.
(f) The name of each of the drug manufacturer's prescription
drugs that was approved by the United States Food and Drug Administration in
the previous 5 calendar years.
(g) The name of each of the drug manufacturer's prescription
drugs that lost patent exclusivity in the United States in the previous 5
calendar years.
(h) The amount of money received
through a federal, state, or other governmental program to research and develop
the prescription drug.
(i) The amount spent on
direct-to-consumer advertising for the prescription drug, including, but not
limited to, television advertisements.
(j) The amount spent on lobbying for
each of the following:
(i)
The research and development of the prescription drug.
(ii)
The approval of the prescription drug by the United States Food and Drug
Administration.
(iii)
Including the prescription drug as a mandated benefit under state or federal
law.
(k) The expiration date for the
patent for the prescription drug, whether the drug manufacturer made any
changes to the prescription drug or delivery device for the prescription drug
since receiving the patent, and whether the drug manufacturer sought a new
patent for a similar prescription drug.
(2) The quality of information that a drug manufacturer
submits to the department under this section
must be consistent with the quality of information that the drug manufacturer
includes on the United States Securities and Exchange Commission's Form 10-K.
Sec. 9. (1) Subject to
subsection (2), a drug manufacturer shall notify the department
in writing if the drug manufacturer is introducing a new prescription
drug to the market at a wholesale acquisition cost that exceeds the threshold
set for a specialty drug under the Medicare Part D Program. The drug
manufacturer shall provide the notice required under this section in a form and manner required by the department and not
later than 3 calendar days following the release of the prescription
drug into the commercial market. A drug manufacturer may make the notification
pending approval by the United States Food and Drug Administration if
commercial availability is expected not later than 3
calendar days following the approval. The director may request additional
information from the drug manufacturer under this section if the director
determines that the information provided by the drug manufacturer is
unacceptable.
(2) The notice required under subsection (1) must include all
of the following information:
(a) Whether the United States Food and Drug Administration
granted the prescription drug a breakthrough therapy designation or a priority
review.
(b) If the prescription drug was not developed by the drug
manufacturer, the date of and price paid for the acquisition of the
prescription drug by the drug manufacturer.
(c) The costs for researching and developing the prescription
drug with money made available to the drug manufacturer, or a predecessor drug
manufacturer, through a federal, state, or other governmental program.
Sec. 11. (1) The department shall prepare an annual report
based on the information that the department receives
under this act. The report must contain aggregate data and must not
contain any information that the director determines would cause financial,
competitive, or proprietary harm to a drug manufacturer. The director shall
file the report described in this subsection with each of the following:
(a) The house of representatives and
senate standing committees on health policy.
(b) The house and senate fiscal agencies.
(c) The caucus policy offices of the
house and senate.
(2) The department shall post the
annual report described in subsection (1) on the department's website in a
location that is accessible to the public and in a manner that is easy to
navigate.
Sec. 13. The reports and
information received by the department under this act from drug manufacturers
are exempt from disclosure under the freedom of information act, 1976 PA 442,
MCL 15.231 to 15.246.
Sec. 15. A drug
manufacturer that violates this act may be ordered to pay a civil fine of not
more than $100,000.00 per month for each month that a report is not filed by
the drug manufacturer in accordance with this act. A violation of this act may
be prosecuted by the prosecutor of the county in which the violation occurred or by the attorney general.
Sec. 17. The department
may promulgate rules under the administrative procedures act of 1969, 1969 PA
306, MCL 24.201 to 24.328, that are necessary or
required to implement this act.
Sec.
19. This act takes effect January 1, 2027.