Sec. 302. Public funding for clinical trials
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Part E of title IV of the Public Health Service Act ( 42 U.S.C. 287 et seq.) is amended by adding at the end the following: There is established within the National Institutes of Health the Center for Clinical Research, for the purpose of conducting clinical trials on drugs, as described in subsection (b), with the intention of obtaining approval of such drug under section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of this Act. The Director of NIH shall appoint a Director of the Center for Clinical Research referred to in this section as the Director ) not later than 90 days after the date of enactment of the Affordable Medications Act .
Each year, beginning not later than 1 year after the date of enactment of the Affordable Medications Act , the Director shall select at least 2 molecules, compounds, drugs, or biological products and conduct clinical trials on such molecules, compounds, drugs, or biological products, or enter into contracts with other entities to conduct such clinical trials. The Director shall establish criteria, which shall be made public, for acquiring the patent rights for, and selecting, drugs under paragraph
(1)to ensure that the drugs selected for clinical trials through the Center— have the potential to address an existing or emerging need, including drugs that can be repurposed to treat a new condition in the case of a national emergency; and are not solely drugs that private sector researchers with access to all available information on such drugs chose not to develop. The Director shall secure all patent rights to each drug selected under paragraph (1), as applicable, and perform the clinical trials at NIH or subcontract with another entity to conduct the clinical trials. If a drug for which clinical trials have been conducted by the Center for Clinical Research is approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of this Act, the Director shall— execute non-exclusive licenses to allow drug manufacturers to manufacture and sell the drug; or in collaboration with other Federal agencies as appropriate, enter into purchasing contracts. Subject to applicable patient privacy protections, the Secretary shall— submit all completed studies (and terminated studies, if terminated for safety or ethical reasons) for publication in a peer-reviewed publication within 180 days of completion or termination; and if a study submitted as described in clause
(i)is not selected for publication, publicly disclose all de-identified primary clinical data not later than 180 days after the Secretary's final decision not to pursue further submissions for publication; and publicly disclose all de-identified primary clinical data upon publication of a study as described in subparagraph (A)(i). The Director shall make public all costs to the Federal Government associated with carrying out clinical trials by the Center for Clinical Research and with subcontract agreements under this section, in a manner that identifies the cost associated with each trial. In this section, the term drug has the meaning given such term in section 201(g) of the Federal Food, Drug, and Cosmetic Act. For the purpose of carrying out this section, in addition to any other funds available for such purpose, there are authorized to be appropriated, and there are appropriated, $1,000,000,000 for each of fiscal years 2020 through 2030, to remain available until expended. . Section 401(b) of the Public Health Service Act ( 42 U.S.C. 281(b) ) is amended— by redesignating paragraph
(25)as paragraph (26); and by inserting after paragraph
(24)the following: The Center for Clinical Research. .
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