Increasing transparency in generic drug applications

(a)

In general

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:

(H)(i)Upon request (in controlled correspondence or otherwise) by a person that has submitted or intends to submit an abbreviated application under this subsection for a drug that is generally required by regulation or recommended in guidance to contain the same inactive ingredients in the same concentration as the listed drug referred to or for which there is a scientific justification that an in vitro approach can be used to demonstrate bioequivalence based on certain qualitative or quantitative criteria with respect to an inactive ingredient, or on the Secretary’s own initiative during the review of an application under this subsection for such a drug, the Secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug. (ii)If the Secretary determines that such drug is not qualitatively or quantitatively the same as the listed drug, the Secretary shall identify and disclose to the person—(I)the ingredient or ingredients that cause the drug not to be qualitatively or quantitatively the same as the listed drug; and(II)for any ingredient for which there is an identified quantitative deviation, the amount of such deviation.(iii)If the Secretary determines that such 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 drug under this subsection unless—(I)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of the listed drug has been changed and the Secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness; or(II)the Secretary makes a written determination that the prior determination must be changed because an error has been identified. (iv)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).(v)The disclosures required by this subparagraph are disclosures authorized by law, including for purposes of section 1905 of title 18, United States Code.

(b)

Guidance

(1)

In general

Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance, or update guidance, describing how the Secretary will determine whether a drug is qualitatively and quantitatively the same as the listed drug (as such terms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.(2)

Process

In issuing guidance under this subsection, the Secretary of Health and Human Services shall—(A)publish draft guidance;(B)provide a period of at least 60 days for comment on the draft guidance; and(C)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.(c)

Applicability

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.