Sec. 2. Identification of excessively priced life-sustaining prescription drugs
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/bill/116/hr/5039/ih/section-2·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The Secretary, not later than 1 year after the date of enactment of this Act, shall establish a process to conduct a review of all life-sustaining prescription drugs, not less frequently than once per calendar year, under which the Secretary determines under subsection
(b)whether the price of each such drug is excessive. The Secretary shall determine that any life-sustaining prescription drug for which the domestic average manufacturing price exceeds 110 percent of the average price charged for such drug in the 5 reference countries to have an excessive price. In assessing the extent to which the price is excessive, the Secretary shall consider the factors described in paragraph (2). In this Act, the term reference countries means Canada, the United Kingdom, Germany, France, and Japan. The Secretary shall make a determination under paragraph
(1)for every life-sustaining prescription drug for which pricing information is available for at least 3 of the 5 reference countries. With respect to any life-sustaining prescription drug that is not determined to have an excessive price by operation of paragraph
(1)(including any drug for which there is insufficient data to make such a determination under such paragraph), the Secretary shall determine that such drug has an excessive price if the price of the drug is higher than reasonable taking into account the following factors: The size of the affected patient population. The risk adjusted value of Federal Government subsidies and investments related to the drug. The costs associated with development of the drug. Whether the drug provided a significant improvement in health outcomes, compared to other therapies available at the time of its approval. The cumulative global revenues generated by the drug. Whether the domestic average manufacturer price of the drug increased during any annual quarter by a percentage that is more than the percentage increase in the consumer price index for all urban consumers for the respective annual quarter. Other factors the Secretary determines appropriate. Any person may petition the Secretary, in accordance with section 553(e) of title 5, United States Code, to make an excessive drug price determination for an applicable drug under subsection (b)(2). Not later than 90 days after the date of receipt of such a petition, subject to paragraph (2), the Secretary shall— make a determination under subsection (b)(2) regarding such drug; or decline to make such a determination; and make public the reasons why the Secretary has declined to make such a determination. The Secretary shall not make a determination under subsection (b)(2) for a drug in response to a petition under this section more frequently than once per calendar year. The Secretary shall make any petitions submitted under this subsection, together with any documentation related to the petitions and the Secretary's determinations on such petitions and rationale for such determinations, publicly available, including by posting such information on the database under section 5.