Sec. 2. Establishment of the Bureau of Prescription Drug Affordability and Access
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There is established within the Department of Health and Human Services an independent bureau, known as the Bureau of Prescription Drug Affordability and Access (in this Act referred to as the Bureau ) to carry out the duties described in this section. The purposes of the Bureau are to— attain lower prescription drug costs for patients; decrease government expenditures on prescription drugs; and ensure access to prescription drugs. The Bureau shall be considered an Executive agency, as defined in section 105 of title 5, United States Code.
The Bureau shall be headed by a Director (in this Act referred to as the Director ) who shall be appointed by the President, by and with the advice and consent of the Senate. The President shall nominate the Director from among individuals who are citizens of the United States. The Director shall serve for a term of 5 years. The term of the first Director to be appointed shall begin on the date that is 180 days after the date of enactment of this Act. In carrying out the duties under this section, the Bureau shall regularly consult with relevant stakeholders, including patients, representatives of relevant Federal agencies, and medical and health care finance experts.
The Bureau shall have regular public meetings to solicit input from relevant stakeholders. The Director shall ensure that patients or organizations representing patients have opportunities to meaningfully engage with the Bureau as it conducts its work, including while the Bureau makes appropriate price determinations under section 3(d). Such opportunities may include holding regular panels, forums, and other meetings for patient engagement. The Director shall establish a process by which patients can petition the entity and raise concerns about the price of their prescription drugs.
The Director shall establish a Consumer Advisory Council to advise and consult with the Bureau as it conducts its work. The Council established under this subparagraph shall be composed of not fewer than 6 members appointed by the Director. In appointing members to the Council, the Director shall ensure that at least half of the members of the Council are patients or organizations representing patients, particularly those who have been significantly impacted by high priced medications.
The Director shall also seek to appoint members to the Council who are experts in relevant areas, including medicine and health care finance. The Consumer Advisory Council shall meet from time to time at the call of the Director but shall meet at least twice a year. An individual who has a conflict of interest shall not be appointed to be a member of, or employed by, the Bureau, including the Consumer Advisory Council established under paragraph (4)(C). Individuals under consideration for employment by, or appointment to, the Bureau, including the Consumer Advisory Council, must disclose any potential conflict of interest, including the type, nature, and magnitude of the interests involved.
The Bureau shall carry out the following duties: Carry out the provisions of section 3. Submit the annual reports under subsection (c). Any other duty that the Director determines appropriate. Not later than January 1, 2021, and annually thereafter, the Director shall submit to Congress a report on the activities of the Bureau. Each report under paragraph
(1)shall contain the following: A description of the activities of the Bureau, including— the total estimated savings achieved by the Bureau since the most recent report; the disaggregated savings achieved since the most recent report, including by each therapeutic class of prescription drugs; a summary of the information submitted by prescription drug manufacturers as required under section 3; and the impact of the Bureau’s work on patient affordability and access to prescription drugs. Recommendations for such legislation and administrative action as the Bureau determines appropriate. A copy of each report submitted by drug manufacturers as required under section 3. Other items that the Bureau determines appropriate. There are appropriated, from amounts in the Treasury not otherwise appropriated, $50,000,000 for fiscal year 2020 and each subsequent fiscal year to carry out the activities of the Bureau. Amounts appropriated under the preceding sentence shall remain available until expended.