CHAPTER 4
HB 703-FN - FINAL VERSION
19Mar2019... 0908h
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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AMENDED ANALYSIS
This bill requires prescription drug manufacturers to provide certain notice to the insurance department 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Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
19Mar2019... 0908h 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:
4:1 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. "Department" means the insurance department.
II. “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.
III. “Prescription drug” means a drug defined in 21 U.S.C. section 321.
318:68 Notice Required.
I. A prescription drug manufacturer shall notify the department 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 department in a format that the department 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 department 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.
4:2 Effective Date. This act shall take effect January 1, 2020.
Approved: February 10, 2020
Effective Date: January 01, 2020
| Date | Body | Type |
|---|---|---|
| Feb. 19, 2019 | House | Hearing |
| Feb. 21, 2019 | House | Exec Session |
| March 8, 2019 | House | Exec Session |
| March 19, 2019 | House | Floor Vote |
| May 7, 2019 | Senate | Hearing |
| Jan. 8, 2020 | Senate | Floor Vote |
Feb. 10, 2020: Signed by Governor Sununu 02/10/2020; Chapter 4; 01/01/2020
Jan. 9, 2020: Enrolled 01/09/2020 HJ 2 P. 58
Jan. 8, 2020: Enrolled (In recess 01/08/2020); SJ 2
Jan. 8, 2020: Ought to Pass: MA, VV; OT3rdg; 01/08/2020; SJ 1
Jan. 8, 2020: Committee Report: Ought to Pass, 01/08/2020; SC 47
May 15, 2019: Rereferred to Committee, MA, VV; 05/15/2019; SJ 16
May 15, 2019: Sen. Sherman Moved to Remove HB 703-FN from the Consent Calendar; 05/15/2019; SJ 16
May 15, 2019: Committee Report: Rereferred to Committee, 05/15/2019; Vote 5-0; CC; SC 22
May 7, 2019: Hearing: 05/07/2019, Room 100, SH, 02:15 pm; SC 21
March 28, 2019: Introduced 03/28/2019 and Referred to Commerce; SJ 12
March 19, 2019: Ought to Pass with Amendment 2019-0908h: MA RC 206-141 03/19/2019 HJ 10 P. 77
March 19, 2019: Amendment # 2019-0908h: AA VV 03/19/2019 HJ 10 P. 77
: Minority Committee Report: Inexpedient to Legislate
March 19, 2019: Majority Committee Report: Ought to Pass with Amendment # 2019-0908h for 03/19/2019 (Vote 13-7; RC) HC 16 P. 22
March 8, 2019: ==CONTINUED== Executive Session: 03/08/2019 01:30 pm LOB 302-304
March 8, 2019: Subcommittee Work Session: 03/08/2019 09:00 am LOB 302-304
March 6, 2019: Subcommittee Work Session: 03/06/2019 08:30 am LOB 302
Feb. 21, 2019: ==RECESSED== Executive Session: 02/21/2019 02:00 pm LOB 302
Feb. 21, 2019: Subcommittee Work Session: 02/21/2019 10:30 am LOB 302
Feb. 19, 2019: Public Hearing: 02/19/2019 02:00 pm LOB 302
Jan. 3, 2019: Introduced 01/03/2019 and referred to Commerce and Consumer Affairs HJ 3 P. 27