Bill Text: NJ A1838 | 2024-2025 | Regular Session | Introduced
Bill Title: Establishes New Jersey Active Pharmaceutical Ingredient Regulatory Commission.
Spectrum: Partisan Bill (Democrat 3-0)
Status: (Introduced) 2024-01-09 - Introduced, Referred to Assembly Health Committee [A1838 Detail]
Download: New_Jersey-2024-A1838-Introduced.html
STATE OF NEW JERSEY
221st LEGISLATURE
PRE-FILED FOR INTRODUCTION IN THE 2024 SESSION
Sponsored by:
Assemblyman HERB CONAWAY, JR.
District 7 (Burlington)
SYNOPSIS
Establishes New Jersey Active Pharmaceutical Ingredient Regulatory Commission.
CURRENT VERSION OF TEXT
Introduced Pending Technical Review by Legislative Counsel.
An Act establishing the New Jersey Active Pharmaceutical Ingredient Regulatory Commission and supplementing Title 24 of the Revised Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. As used in this act:
"Commission" means the New Jersey Active Pharmaceutical Ingredient Regulatory Commission.
2. The New Jersey Active Pharmaceutical Ingredient Regulatory Commission is created and established in the executive branch of the State Government. For the purposes of complying with the provisions of Article V, Section IV, paragraph 1 of the New Jersey Constitution, the commission is allocated within the Department of the Treasury, but notwithstanding this allocation, the commission shall be independent of any supervision or control by the department or by any board or officer thereof.
3. a. The commission shall consist of the following 17 members:
(1) four public members to be appointed by the Governor, with the advice and consent of the Senate, with each public member having a background in the field or business of pharmaceuticals, one public member having a general background in pharmaceutical manufacturing, and at least one public member having a background in active pharmaceutical ingredient manufacturing;
(2) two public members to be appointed by the Governor upon the recommendation of the President of the Senate and two public members to be appointed by the Governor upon the recommendation of the Speaker of the General Assembly, with each public member having a background in the field or business of pharmaceuticals or active pharmaceutical ingredient manufacturing;
(3) two members of the Senate, who shall not be of the same political party, to be appointed by the President of the Senate and who shall serve as ex officio, non-voting members, and two members of the General Assembly, who shall not be of the same political party, to be appointed by the Speaker of the General Assembly and who shall serve as ex officio, non-voting members;
(4) the Commissioner of Health, ex officio, or the commissioner's representative;
(5) the Executive Director of the New Jersey Economic Development Authority, ex officio, or the executive director's representative;
(6) the Executive Director of the New Jersey Commission of Science, Innovation and Technology, ex officio, or the executive director's representative; and
(7) two presidents of a State public or private research institution of higher education, who shall be appointed annually by the Governor and who shall serve as ex officio, non-voting members.
b. In the selection of public members, a strong effort shall be made to appoint women and minorities to the commission.
c. The commission members who are not members of the Senate or the General Assembly and who are not presidents of a State public or private research institution of higher education shall have a right to vote on various matters considered by the commission.
4. a. The terms of the public members of the commission appointed by the Governor shall be for five years or until their successors are appointed, except that of the appointments first made to the commission: three shall serve for three years or until their successors are appointed, three shall serve for four years or until their successors are appointed, and three shall serve for five years or until their successors are appointed. Any vacancy shall be filled in the same manner as the original appointment but only for the balance of the unexpired term. The commission members shall serve without compensation but shall be reimbursed for necessary expenses incurred in the performance of their duties, within the limits of funds appropriated or otherwise made available to the commission for its purposes.
b. Each member appointed by the Governor may be removed from office by the Governor, for cause, after a public hearing, and may be suspended by the Governor pending the completion of the hearing. Each member, before entering upon the member's duties, shall take and subscribe an oath to perform the duties of the office faithfully, impartially, and justly to the best of the member's ability. A record of these oaths shall be filed in the office of the Secretary of State.
5. The Governor shall designate the chair of the commission from among the public members appointed by the Governor.
6. a. The commission shall appoint an executive director, who shall serve at the pleasure of the commission and who shall receive compensation as provided by law.
b. The executive director shall be responsible for the selection of properly qualified staff members of the commission. Staff members shall have backgrounds in the field or business of pharmaceuticals.
7. The commission shall:
a. establish standards and
provide oversight of the manufacture
of active pharmaceutical ingredients in the State and for the quality and use
of active pharmaceutical ingredients manufactured outside of the State in a
manner that is consistent with federal law;
b. promote the growth of the active pharmaceutical ingredient manufacturing industry in this State, with a focus on the use of available federal monies and resources;
c. act as a liaison between the pharmaceutical industry and the State and federal governments as it pertains to identifying federal funding and grant opportunities for members of the industry;
d. adopt rules and regulations pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.) if necessary to effectuate the provisions of this act;
e. adopt, amend, and repeal bylaws for the regulation of its affairs and the conduct of its business;
f. adopt and have a seal and alter the same at its pleasure;
g. have the authority to sue and be sued;
h. have the authority to conduct meetings and public hearings in connection with the purposes of this act;
i. receive and disburse funds from non-State sources including but not limited to federal funds; and
j. have the authority to do any and all things necessary or convenient to carry out its purposes and exercise the powers granted in this act.
8. This act shall take effect immediately.
STATEMENT
This bill establishes the New Jersey Active Pharmaceutical Ingredient Regulatory Commission (commission).
Under the bill, the commission
is to consist of the following 17 members: (1) four public members to be
appointed by the Governor, with the advice and consent of the Senate, with each
public member having a background in the field or business of pharmaceuticals,
one public member having a general background in pharmaceutical manufacturing,
and at least one public member having a background in active pharmaceutical
ingredient manufacturing; (2) two public members to be appointed by the
Governor upon the recommendation of the President of the Senate and two public
members to be appointed by the Governor upon the recommendation of the Speaker
of the General Assembly, with each public member having a background in the
field or business of pharmaceuticals or active pharmaceutical ingredient
manufacturing; (3) two members of the Senate, who are not to be of the same
political party, to be appointed by the President of the Senate and
who are to serve as ex officio, non-voting members, and two members of the
General Assembly, who are not to be of the same political party, to be
appointed by the Speaker of the General Assembly and who is to serve as ex
officio, non-voting members; (4) the Commissioner of Health, ex officio, or the
commissioner's representative; (5) the Executive Director of the New Jersey
Economic Development Authority, ex officio, or the executive director's
representative; (6) the Executive Director of the New Jersey Commission of Science,
Innovation and Technology, ex officio, or the executive director's
representative; and (7) two presidents of a State public or private research
institution of higher education, who are to be appointed annually by the
Governor and who are to serve as ex officio, non-voting members. In the
selection of public members, a strong effort is to be made to appoint women and
minorities to the commission.
Under the bill, the commission is to: (1) establish standards and provide oversight of the manufacture of active pharmaceutical ingredients in the State and for the quality and use of active pharmaceutical ingredients manufactured outside of the State in a manner that is consistent with federal law; (2) promote the growth of the active pharmaceutical ingredient manufacturing industry in this State, with a focus on the use of available federal monies and resources; (3) act as a liaison between the pharmaceutical industry and the State and federal governments as it pertains to identifying federal funding and grant opportunities for members of the industry; (4) adopt rules and regulations pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.) if necessary to effectuate the provisions of this act; (5) adopt, amend, and repeal bylaws for the regulation of its affairs and the conduct of its business; (6) adopt and have a seal and alter the same at its pleasure; (7) have the authority to sue and be sued; (8) have the authority to conduct meetings and public hearings in connection with the purposes of this act; (9) receive and disburse funds from non-State sources including but not limited to federal funds; and (10) have the authority to do any and all things necessary or convenient to carry out its purposes and exercise the powers granted in this act.
On February 24, 2021, the
Biden administration issued an executive order requiring the review of active pharmaceutical
ingredient supply chains. The executive order directs a 100-day review and
strategy development process to identify and address vulnerabilities in the
supply chains of four key product sectors which are: semiconductor manufacturing
and advanced packaging, large capacity batteries, critical minerals and
materials, and pharmaceuticals and active pharmaceutical ingredients. With regards
"to promot[ing] domestic growth, equity, and resilience
throughout the pharmaceutical" and active pharmaceutical ingredient supply
chains, the executive order prescribes "a strategic approach that includes
the following three elements[:]" 1) boosting local production to foster
international competition; 2) building
emergency capacity; and 3) increasing information available to the Federal Drug Administration to improve its surveillance and shortage prevention and mitigation efforts.
