Revision: Jan. 17, 2019, 2:54 p.m.
HB 703-FN - AS INTRODUCED
2019 SESSION
19-0806
01/05
HOUSE BILL 703-FN
AN ACT relative to providing notice of the introduction of new high-cost prescription drugs.
SPONSORS: Rep. Butler, Carr. 7; Rep. Knirk, Carr. 3; Sen. Sherman, Dist 24
COMMITTEE: Commerce and Consumer Affairs
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ANALYSIS
This bill requires prescription drug manufacturers to provide certain notice to the office of the attorney general if they are 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.
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Explanation: Matter added to current law appears in bold italics.
Matter removed from current law appears [in brackets and struckthrough.]
Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
19-0806
01/05
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Nineteen
AN ACT relative to providing notice of the introduction of new high-cost prescription drugs.
Be it Enacted by the Senate and House of Representatives in General Court convened:
1 New Subdivision; New High-Cost Prescription Drugs. Amend RSA 318 by inserting after section 66 the following new subdivision:
New High-Cost Prescription Drugs
318:67 Definitions. In this subdivision:
I. "Office" means the office of the attorney general.
II. “Prescription drug” means a drug defined in 21 U.S.C. section 321.
III. “Manufacturer” means any entity which is engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drugs, whether directly or indirectly by extraction from substances of natural origin, independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, or any entity engaged in the packaging, repackaging, labeling, relabeling, or distribution of prescription drugs. The term shall not include a wholesale distributor of prescription drugs, a retailer, or a pharmacist licensed under the board.
318:68 Notice Required.
I. A prescription drug manufacturer shall notify the office 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 3 calendar days following the release of the drug in the commercial market. A manufacturer may make the notification pending approval by the United States Food and Drug Administration (FDA) if commercial availability is expected within 3 calendar days following the approval.
II. No later than 30 calendar days following notification required under paragraph I, the manufacturer shall provide the following information to the office in a format that the office prescribes:
(a) A description of the marketing and pricing plans used in the launch of the new drug in the United States and internationally.
(b) The estimated volume of patients who may be prescribed the drug.
(c) Whether the drug was granted breakthrough therapy designation or priority review by the FDA prior to final approval.
(d) The date and price of acquisition if the drug was not developed by the manufacturer
III. The manufacturer may limit the information required under paragraph II to that which is otherwise in the public domain or publicly available.
IV. The office shall publish on its Internet website, at least quarterly, the information reported to it under 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.
V. The attorney general may bring a civil action for injunctive relief, costs, and attorney’s fees and impose on a manufacturer that fails to provide the information required under paragraph II, a civil penalty of not more than $1,000 per day for every day after the notification period described in paragraph II that the required information is not reported. In any action brought under this section, the attorney general shall have the same authority to investigate and obtain remedies as if the action were brought under the RSA 358-A.
2 Effective Date. This act shall take effect January 1, 2020.
19-0806
1/17/19
HB 703-FN- FISCAL NOTE
AS INTRODUCED
AN ACT relative to providing notice of the introduction of new high-cost prescription drugs.
FISCAL IMPACT: [ X ] State [ ] County [ ] Local [ ] None
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| Estimated Increase / (Decrease) | |||
STATE: | FY 2020 | FY 2021 | FY 2022 | FY 2023 |
Appropriation | $0 | $0 | $0 | $0 |
Revenue | $0 | $0 | $0 | $0 |
Expenditures | Indeterminable Increase | Indeterminable Increase | Indeterminable Increase | Indeterminable Increase |
Funding Source: | [ X ] General [ ] Education [ ] Highway [ ] Other | |||
METHODOLOGY:
This bill requires prescription drug manufacturers to provide written notice to the Department of Justice if they introduce 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 bill requires the Department to publish the reported information on its website. Finally, the bill allows the Department to bring a civil action against a manufacturer that fails to provide the requisite information. The Department assumes that it will need to hire a part-time legal assistant to review the required reports. Because the Department is unable to predict the number of civil actions that may occur as a result of the bill, the total fiscal impact is indeterminable. The cost of the part-time legal assistant is as follows:
| FY 2020 | FY 2021 | FY 2022 | FY 2023 |
Salary and Benefits | $33,621 | $34,993 | $36,512 | $37,965 |
Other | $2,300 | $550 | $550 | $550 |
Total | $35,921 | $35,543 | $37,062 | $38,515 |
AGENCIES CONTACTED:
Department of Justice