Bill > A1838

Introduced Session

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.

AI Summary

Committee Categories

Jessica Ramirez (D)*,  Shanique Speight (D)*, 

Assembly Health Hearing (10:00:00 1/29/2024 Canceled) (on 01/29/2024)

Official Document