Establishing the Prescription Drug Regulatory Commission

(a) In general There is established the Prescription Drug Price Regulatory Commission (in this section referred to as the Commission). (b) Duties of Commission (1) In general Not later than the fair price recommendation date with respect to a fair price applicability year, the Commission shall, with respect to each approved prescription drug, submit to the Secretary of Health and Human Services (in this section referred to as the Secretary) a recommendation regarding the price that the Commission determines to be a fair price for such drug in order for the manufacturer of such drug to provide access to such price— (A) to any fair price eligible individual who is dispensed such drug during such fair price applicability year (and to pharmacies, mail order services, and other dispensers, with respect to such individuals who are dispensed such drugs); and (B) to any hospital, physician, or other provider of services or supplier that furnishes or administers such drug to such an individual during such year. (2) Fair price revisions and waivers At any time during a fair price applicability year, the Commission may submit to the Secretary a recommendation— (A) that the Secretary revise the fair price established for an approved prescription drug for such year under section 3(b); or (B) that the Secretary authorize a temporary waiver of such fair price under section 3(c). (3) Required factors for consideration In making a recommendation under paragraph (1) with respect to the fair price of an approved prescription drug, or a recommendation under paragraph (2) with respect to a revision or waiver of such fair price, the Commission shall take into account the following factors with respect to such drug: (A) The costs to the manufacturer of producing and distributing of such drug. (B) The cost-effectiveness of the drug and its therapeutic benefit (which may be determined on the basis of quality-adjusted life years, equal value of life years gained, or such other measure as the Commission may specify). (C) The anticipated demand for the drug during the fair price applicability year. (D) The costs and risks to the manufacturer involved in researching and developing such drug, and the return on investment that would provide adequate incentive to the manufacturer to continue research. (E) In the case that such drug is available for purchase in 1 or more comparable reference countries, the average price of such drug in such country. (F) Such other factors as the Secretary of Health and Human Services may specify through rulemaking. (c) Members of Commission (1) In general The Commission shall be composed of 13 members as follows: (A) Seven members appointed by the President from individuals who are not officers or employees of any government. (B) Six ex officio members appointed by the Secretary of Health and Human Services from each of the following agencies: (i) The Veterans Health Administration. (ii) The Defense Health Agency. (iii) The Centers for Medicare & Medicaid Services. (iv) The Food and Drug Administration. (v) The Centers for Disease Control and Prevention. (vi) The Federal Trade Commission. (2) Terms Each member shall be appointed for a term of 4 years, except that the Secretary may extend the term of any member for 1 additional year if the Secretary determines such extension appropriate. (d) Operation In carrying out the duties under subsection (b), the Commission is not subject to the provisions of chapter 10 of title 5, United States Code. (e) Authorization of appropriations There are authorized to be appropriated such sums as may be necessary for each fiscal year to carry out the activities of the Commission.