IBOGAINE Act

524C. National Health Priority Voucher Pilot Program

(a) Definitions. In this section:

(1) Priority review. The term priority review, with respect to a human drug application as defined in section 735(1), means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007.

(2) National health priority review voucher. The term national health priority review voucher means a voucher issued by the Secretary to the sponsor of a national health priority product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 505(b)(1) of this Act or section 351 of the Public Health Service Act after the date of approval of the national health priority product application.

(3) National health priority product. The term national health priority product means any of the following:

(A) Public health crisis response. A product to treat or prevent an urgent or emerging threat that the Secretary has identified as having a significant impact on the population of the United States.

(B) Breakthrough therapies. A drug that—

(i) is designated as a breakthrough therapy under section 506(a); and

(ii) is a transformative treatment with one or more novel mechanisms that fundamentally change the management of one or more diseases or conditions.

(C) Large unmet medical needs. A therapy for a disease or condition for which existing treatments inadequately address patient outcomes.

(D) Onshoring and supply chain resilience. A product whose development or manufacture in the United States would strengthen the Nation’s domestic capacity, reduce foreign dependency, and improve national security with respect to the drug supply chain.

(E) Affordability. A product that—

(i) improves overall value through reduced costs to the health care system; or

(ii) enhances access to important health care products.

(F) Other products. Any other national health priority product whose approval would—

(i) address a health crisis in the United States;

(ii) deliver an innovative cure;

(iii) address an unmet public health need; and

(iv) increase domestic drug manufacturing as a matter of national security.

(4) National health priority product application. The term national health priority product application means an application that—

(A) is a human drug application as defined in section 735(1); and

(B) is for a national health priority product.

(b) Priority review voucher

(1) In general. The Secretary shall award a national health priority review voucher to the sponsor of a national health priority product application upon approval by the Secretary of such application.

(2) Prohibition on transferability. The sponsor of a national health priority product that receives a national health priority review voucher may not transfer the entitlement to such voucher, except that if ownership of the sponsor is transferred to a different entity the entitlement to such voucher may be transferred to such entity as part of the change in ownership.

(3) Limitations. A sponsor of a national health priority product application may not—

(A) receive more than one national health priority review voucher during any 24-month period; or

(B) apply for an additional national health priority review voucher while in possession of such a voucher.

(c) Priority voucher user fee

(1) In general. The Secretary may establish a user fee program under which a sponsor of a human drug application that is the subject of a national health priority review voucher shall pay to the Secretary a fee determined under paragraph (2). Such fee shall be in addition to any fee required to be submitted by the sponsor under chapter VII.

(2) Fee amount. The amount of the user fee under paragraph (1) shall be determined each fiscal year by the Secretary and based on the average cost incurred by the agency in the review of a human drug application subject to priority review in the previous fiscal year.

(3) Annual fee setting. The Secretary shall establish, before the beginning of each fiscal year beginning after September 30, 2026, for that fiscal year, the amount of the user fee under paragraph (1).

(4) Offsetting collections. Fees collected pursuant to this subsection for any fiscal year—

(A) shall be deposited and credited as offsetting collections to the account providing appropriations to the Food and Drug Administration; and

(B) shall not be collected for any fiscal year except to the extent provided in advance in appropriation Acts.

(d) Eligibility for other programs. Nothing in this section precludes a sponsor who seeks a national health priority review voucher from participating in any other incentive program, including under this Act, except that no sponsor of a national priority health product application may receive more than one national health priority review voucher with respect to the drug for which the application is made.

(e) Relation to other provisions. The provisions of this section shall supplement, not supplant, any other provisions of this Act or the Public Health Service Act that encourage the development of drugs for tropical diseases, rare pediatric diseases, or national health priority products.

(f) Advice. The Secretary shall provide prompt advice to the sponsor of a national health priority product application for which the sponsor seeks a voucher under this section to enable the sponsor—

(1) to plan a development program to obtain the necessary data for approval of the national health priority product that is the subject of such application; and

(2) to conduct any additional studies that would be required for approval of such product for use in a broader population.

(g) GAO study and report

(1) Study

(A) In general. The Comptroller General of the United States shall conduct a study of the effectiveness of awarding national health priority review vouchers in the development of human drug products.

(B) Contents of study. In conducting the study under subparagraph (A), the Comptroller General shall examine the following:

(i) With respect to each national health priority review voucher awarded:

(I) Whether, and to what extent, an unmet need related to the treatment or prevention of a disease or condition was met through the approval of a national health priority product.

(II) Identification of each drug for which the voucher was used.

(III) The length of the period of time between the date on which the voucher was awarded and the date on which it was used.

(ii) Whether the pathway under this section has helped to provide safe and effective treatments for patients.

(iii) Whether a similar voucher program would be appropriate for other categories of drugs.

(2) Report. Not later than 1 year after the date of enactment of this section, the Comptroller General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, a report containing the results of the study under paragraph (1).

(h) Termination of authority. The Secretary may not award a voucher under this section after September 30, 2029.