The Vermont Statutes Online
The Statutes below include the actions of the 2025 session of the General Assembly.
NOTE: The Vermont Statutes Online is an unofficial copy of the Vermont Statutes Annotated that is provided as a convenience.
Subchapter
003
:
INFORMATION REQUIREMENTS
(Cite as: 18 V.S.A. § 4637)
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§ 4637. Notice of introduction of new high-cost prescription drugs
(a) As used in this section:
(1) “Manufacturer” shall have the same meaning as “pharmaceutical manufacturer” in section 4631a of this title.
(2) “Prescription drug” means a drug as defined in 21 U.S.C. § 321.
(b) A prescription drug manufacturer shall notify the Office of the Attorney General in
writing if it is introducing a new prescription drug to market at a wholesale acquisition
cost that exceeds the threshold set for a specialty drug under the Medicare Part D
program. The manufacturer shall provide the written notice within three calendar days
following the release of the drug in the commercial market. A manufacturer may make
the notification pending approval by the U.S. Food and Drug Administration (FDA) if
commercial availability is expected within three calendar days following the approval.
(c) Not later than 30 calendar days following notification pursuant to subsection (b)
of this section, the manufacturer shall provide all of the following information to
the Office of the Attorney General in a format that the Office prescribes:
(1) a description of the marketing and pricing plans used in the launch of the new drug
in the United States and internationally;
(2) the estimated volume of patients who may be prescribed the drug;
(3) whether the drug was granted breakthrough therapy designation or priority review by
the FDA prior to final approval; and
(4) the date and price of acquisition if the drug was not developed by the manufacturer.
(d) The manufacturer may limit the information reported pursuant to subsection (c) of
this section to that which is otherwise in the public domain or publicly available.
(e) The Office of the Attorney General shall publish on its website at least quarterly
the information reported to it pursuant to this section. The information shall be
published in a manner that identifies the information that is disclosed on a per-drug
basis and shall not be aggregated in a manner that would not allow identification
of the drug.
(f) The Attorney General may bring an action in the Civil Division of the Superior Court,
Washington County for injunctive relief, costs, and attorney’s fees and to impose
on a manufacturer that fails to provide the information required by subsection (c)
of this section a civil penalty of not more than $1,000.00 per day for every day after
the notification period described in subsection (b) of this section that the required
information is not reported. In any action brought pursuant to this section, the Attorney
General shall have the same authority to investigate and to obtain remedies as if
the action were brought under the Consumer Protection Act, 9 V.S.A. chapter 63. (Added 2017, No. 193 (Adj. Sess.), § 10, eff. May 30, 2018.)