Sec. 5. Drug Affordability and Access Committee
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There is hereby authorized to be established a nonprofit corporation to be known as the Drug Affordability and Access Committee (referred to in this section as the Committee ), which is neither an agency nor establishment of the United States Government. The Committee shall be headed by an Executive Director. The purpose of the Committee is to determine a reasonable manufacturer list price and retail price for each applicable drug. The Committee shall have a Board of Directors, which shall be composed of ex officio and appointed members in accordance with this subsection.
All appointed members of the Board shall be voting members. The non-voting ex officio members of the Committee shall be the following individuals or their designees: The Secretary of Health and Human Services. The Director of the National Institutes of Health. The Commissioner of Food and Drugs. The Director of the Agency for Healthcare Research and Quality. The Director of the Centers for Disease Control and Prevention. The Administrator of the Centers for Medicare & Medicaid Services.
The Assistant Secretary for Planning and Evaluation. Ten additional members shall be appointed to the Committee by the Comptroller General of the United States not later than 180 days after the date of enactment of this Act. Such members shall include— 2 patient and consumer representatives not affiliated with any organization that receives funding from pharmaceutical manufacturers; 3 provider representatives, including 1 hospital representative and 1 pharmacist representative; 1 health services researcher; 1 health care economist; 1 representative of a sponsor of a health plan or health insurance coverage; 1 pharmacy benefit management services representative; and 1 drug manufacturer representative.
Members appointed to the Committee under subparagraph
(A)shall be appointed to serve 5-year terms, which shall be staggered for the members first appointed. Members appointed to the Committee under subparagraph
(A)may not be so appointed for more than 2 terms. In appointing members under subparagraph (A), the Comptroller General of the United States shall consider and disclose any potential conflicts of interest. Members of the Board shall recuse themselves or be recused from relevant Committee activities in the case where the member (or an immediate family member of such member) has a conflict of interest. A conflict of interest or potential conflict of interest shall be disclosed, as applicable— by the Committee, in appointing members to an advisory committee and for employment as staff on the Committee; and by the Comptroller General of the United States, in appointing members of the Committee. Conflicts of interests shall be disclosed as soon as practicable on the internet websites of the Committee and of the Government Accountability Office. The information so disclosed shall include the type, nature, and magnitude of the interests of the individual involved, except to the extent that the individual recuses himself or herself from participating in the consideration of activity in which the potential conflict exists. The Committee shall maintain the confidentiality of any information provided to the Committee under this section that is a trade secret or confidential information. Vacancies on the Board shall be filled in the same manner as the original appointment was made. Any vacancy in the membership of the Board shall not affect the power of the remaining members to execute the duties of the Board. While serving on the business of the Committee (including travel time), a member of the Committee shall be entitled to compensation at the per diem equivalent of the rate provided for level IV of the Executive Schedule under section 5315 of title 5, United States Code, and while so serving away from home and the member’s regular place of business, a member may be allowed travel expenses, as authorized by the Chairman of the Committee. No employee of the Federal Government shall be an appointed member of the Committee. The Board shall appoint an Executive Director who shall serve at the pleasure of the Board. The Executive Director shall be responsible for the day-to-day operations of the Committee and shall have such specific duties and responsibilities as the Board shall prescribe, including to identify, recruit, and hire staff. The compensation of the Executive Director shall be fixed by the Board. The Executive Director and all staff of the Committee shall be subject to the same conflict of interest and confidentiality requirements as the Board members, as described in subparagraphs
(D)and
(E)of subsection (c)(3). The initial meeting of the Committee shall take place within 60 days of all members being appointed. In the initial meeting, the Committee shall— incorporate the Committee; designate a Chair; and appoint the Executive Director. The duties and authorities of the Committee are as follows: The Committee shall establish administrative guidelines for the Committee, including— establishing bylaws for the Committee that are published in the Federal Register and made available for public comment; establishing policies for the selection of officers, employees, agents, and contractors of the Committee; establishing policies that would subject all employees, fellows, and trainees of the Committee to the conflict of interest standards under subsection (c)(3)(D); specifying a process for annual Board review of the operations of the Committee; establishing specific duties of the Executive Director; evaluating the performance of the Executive Director; and carrying out other necessary activities regarding the functioning of the Committee. Not later than 2 years after receipt of the report of the National Academy of Medicine under section 4, the Committee shall— outline the process and methodology by which the Committee will determine, based on such report, whether the manufacturer list price and retail price is reasonable for each applicable drug; outline the timeline under which the manufacturer, based on such report, is required to submit the information required under section 6(a)(2) to the Committee; outline the timeline under which the Committee is required to determine, based on such report, whether the manufacturer list price and retail price is reasonable for each applicable drug; and publish such proposed process, methodology, and timeline on the internet website of the Committee. Not later than 60 days after publication of the proposed process, methodology, and timeline under subparagraph (A), the Committee shall hold a minimum of 2 public stakeholder meetings to solicit feedback on such proposed process, methodology, and timeline. Not later than 30 months after receipt of the report under section 4, the Committee shall publish a final process, methodology, and timeline on the Committee’s internet website. The Committee may make changes and updates to the final process, methodology, and timeline as necessary. Any such changes or updates shall be published on the internet website of the Committee. The Committee shall issue a reasonable pricing determination for each applicable drug that— is based on a review of the information submitted under section 6(a); and uses the process, methodology, and timeline developed by the Committee under paragraph (2). The Committee shall issue a reasonable pricing determination under subparagraph
(A)for a drug that, upon approval of an application under section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) or section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ), will be an applicable drug, taking into consideration the recommended timeframe under section 4(a)(2). For each reasonable pricing determination made under subparagraph (A), the Committee shall submit a report in writing to the applicable drug manufacturer outlining such determination. Each such report shall be made public, excluding any proprietary information. The Committee may appoint permanent or ad hoc advisory committees as determined appropriate to assist in the work of the Committee. All members of any such advisory committee shall be subject to the same conflict of interest requirements as Committee members. The Committee shall submit an annual report to Congress and to the Secretary, and shall make the annual report available to the public. Each such report shall include— a description of the activities conducted under this Act; the budget of the Committee for the following year; and any other relevant information, including information on the membership of the Board, advisory committees, and the executive staff of the Committee, any conflicts of interest with respect to such individuals, and any bylaws adopted by the Board during the preceding year.
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