Sec. 601. Increasing transparency in generic drug applications
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Section 505(j)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(3) ) is amended by adding at the end the following: Upon request (in controlled correspondence or otherwise) by a person that has submitted or intends to submit an abbreviated application for a new drug under this subsection for which the Secretary has specified in regulation, including in section 314.94(a)(9) of title 21, Code of Federal Regulations (or any successor regulations), or recommended in applicable guidance, certain qualitative or quantitative criteria with respect to an inactive ingredient, or on the Secretary’s own initiative during the review of such abbreviated application, the Secretary shall inform the person whether such new drug is qualitatively and quantitatively the same as the listed drug.
Notwithstanding section 301(j), if the Secretary determines that such new drug is not qualitatively or quantitatively the same as the listed drug, the Secretary shall identify and disclose to the person— the ingredient or ingredients that cause the new drug not to be qualitatively or quantitatively the same as the listed drug; and for any ingredient for which there is an identified quantitative deviation, the amount of such deviation. If the Secretary determines that such new drug is qualitatively and quantitatively the same as the listed drug, the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such new drug under this subsection unless— the formulation of the listed drug has been changed and the Secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness; or the Secretary makes a written determination that the prior determination must be changed because an error has been identified.
If the Secretary makes a written determination described in clause (iii)(II), the Secretary shall provide notice and a copy of the written determination to the person making the request under clause (i). The disclosures required by this subparagraph are disclosures authorized by law including for purposes of section 1905 of title 18, United States Code. . Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance, or update guidance, describing how the Secretary will determine whether a new drug is qualitatively and quantitatively the same as the listed drug (as such terms are used in section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)), including with respect to assessing pH adjusters.
In issuing guidance as required by paragraph (1), the Secretary of Health and Human Services shall— publish draft guidance; provide a period of at least 60 days for comment on the draft guidance; and after considering any comments received, and not later than one year after the close of the comment period on the draft guidance, publish final guidance. Section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies beginning on the date of enactment of this Act, irrespective of the date on which the guidance required by subsection
(b)is finalized.
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Sec. 601
Increasing transparency in generic drug applications
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