Title I, SEC. 1572. ADVISORY COUNCIL ON BREAKTHROUGH DRUGS. (a) In General. The Secretary shall appoint an Advisory Council on Breakthrough Drugs (in this section referred to as the ``Council'') that will examine the reasonableness of launch prices of new drugs that represent a breakthrough or significant advance over existing therapies. (b) Duties. (1) At the request of the Secretary, or a member of the Council, the Council shall make a determination regarding the reasonableness of launch prices of a breakthrough drug. Such a determination shall be based on: (A) prices of other drugs in the same therapeutic class; (B) cost information supplied by the manufacturer; (C) prices of the drug in countries specified in section 302(b)(4)(A) of the Federal Food, Drug, and Cosmetic Act; and (D) projected prescription volume, economies of scale, product stability, special manufacturing requirements and research costs. (2) The Secretary shall review the determinations of the Council and publish the results of such review along with the Council's determination (including minority opinions) as a notice in the Federal Register. (c) Membership. The Council shall consist of a chair and 12 other persons, appointed without regard to the provisions of title 5, United States Code, governing appointments in the competitive service. The Council shall include a representative from the pharmaceutical industry, consumer organizations, physician organizations, the hospital industry, and the managed care industry. Other individuals appointed by the Secretary shall be recognized experts in the fields of health care economics, pharmacology, pharmacy and prescription drug reimbursement. Only one member of the Council may have direct or indirect financial ties to the pharmaceutical industry. (d) Term of Appointments. Appointments shall be for a term of 3 years, except that the Secretary may provide initially for such shorter terms as will ensure that the terms of not more than 5 members expire in any one year. (e) Compensation. Members of the Council shall be entitled to receive reimbursement of expenses and per diem in lieu of subsistence in the same manner as other members of advisory councils appointed by the Secretary are provided such reimbursements under the Social Security Act. (f) No Termination. Notwithstanding the provisions of the Federal Advisory Committee Act, the Council shall continue in existence until otherwise specified in law.