Sec. 4. Reporting on the expenditures of manufacturers with respect to COVID–19 drugs
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For purposes of this section, the term covered drug means a drug that is intended or anticipated to be used to diagnose, mitigate, prevent, or treat COVID–19. The manufacturer of a covered drug shall submit a report described in subsection
(c)to the Secretary upon— the submission of an application for approval of the drug under subsection
(b)or
(j)of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ); investigational use of the drug under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ) or section 351(a)(3) of the Public Health Service Act ( 42 U.S.C. 262(a)(3) ); the submission of an application for licensing the drug under subsection
(a)or
(k)of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); the issuance of an authorization for emergency use of the drug under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ); or the marketing of the drug. A report under subsection (a), consistent with the standard for disclosures described in section 213.3(d) of title 12, Code of Federal Regulations (as in effect on the date of enactment of this Act), shall address the expenditures of the manufacturer with respect to the covered drug and include, at a minimum— the sponsor or sponsors of the covered drug; the current wholesale acquisition cost of the covered drug when applicable; the total expenditures of the manufacturer, specified by individual costs, on— materials and manufacturing for the covered drug; and acquiring patents and licensing for the covered drug; the total amount and percentage of research and development expenditures for the covered drug that was derived from Federal funds; the total amount of any Federal benefits received by the manufacturer with respect to the covered drug, including— the specific amounts and periods of impact for each such benefit; the specific value of any tax credits, including benefits from patient assistance programs and donated samples; clinical and preclinical investments; any Federal benefit toward manufacturing costs, including building or retrofitting facilities; Federal grants, including from the National Institutes of Health, the Centers for Disease Control and Prevention, the Department of Defense, the Department of Energy, or other Federal departments or agencies; patent applications that benefitted from such grants; patent extensions; exclusivity periods; and waivers of fees; the total expenditures of the manufacturer on research and development, itemized by basic and preclinical research and by clinical research, reported separately for each clinical trial, for the covered drug to demonstrate that the covered drug meets applicable statutory standards for approval under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), licensure under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), an exemption for investigational use under section 505(i) of the Federal Food, Drug, or Cosmetic Act ( 21 U.S.C. 355(i) ) or section 351(a)(3) of the Public Health Service Act ( 42 U.S.C. 262(a)(3) ), or authorization under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ), as applicable; the total expenditures of the manufacturer on pursuing new or expanded indications or dosage changes for the covered drug under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); the total expenditures of the manufacturer on carrying out postmarket requirements related to such drug, including under section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3) ); the specific expenditures associated with marketing and advertising costs for the covered drug; any anticipated royalty fees from licensing to other manufacturers; and with respect to the manufacturer— all stock-based performance metrics used by the manufacturer to determine executive compensation over the preceding 12 months; and any additional information the manufacturer chooses to provide related to drug pricing decisions. Any manufacturer of a covered drug that fails to submit a report as required by this section, following notification by the Secretary to the manufacturer that the manufacturer is not in compliance with this section, shall be subject to a civil monetary penalty of $100,000 for each day on which the violation continues. Any manufacturer of a covered drug that knowingly provides false information in a report under this section is subject to a civil monetary penalty in an amount not to exceed $100,000 for each item of false information. Subject to paragraph (3), the Secretary shall post each report submitted under subsection
(b)on the public website of the Department of Health and Human Services no later than 30 days after the submission of the report. The Secretary shall ensure that such reports are— user-friendly to the public; and written in plain language that consumers can readily understand. Nothing in this section shall be construed to authorize the public disclosure of information submitted by a manufacturer that is prohibited from disclosure by any applicable law concerning the protection of trade secrets, commercial information, and other information. In this section, the term drug has the meaning given to such term in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ).
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- 21 USC 360bbb–3
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Sec. 4
Reporting on the expenditures of manufacturers with respect to COVID–19 drugs
Cite21 USC 360bbb–3
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