Reporting Required By Manufacturers Of New High-Cost Prescription Drugs
Pursuant to 18 V.S.A.§ 4637 (Notice of Introduction of New High-Cost Prescription Drugs), effective July 1, 2018, when a prescription drug manufacturer introduces a new prescription drug to market at a wholesale acquisition price above the threshold set for a specialty drug under the Medicare Part D program, that manufacturer is required to provide certain written information to the Attorney General’s Office.
Here is the law:
§ 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.
How to Provide Notice to the Attorney General’s Office
Please send the notices required under Sections (b) and (c) above (the 3 day notice and 30 day notice, respectively) to: AGO.email@example.com. While the Attorney General’s Office does not require the use of a standardized form, written notice must be timely provided with all of the information required by the relevant statutory section. If you have questions related to the provision of notice, you may send those questions to the email address above in advance of the due date of the notice.