Federal

Increasing Transparency in Generic Drug Applications Act

Source: Congress.gov · 860 words in original text

What This Bill Does

This bill requires the government to be more transparent about generic drug applications. Specifically, it requires officials to tell drug companies whether their generic drug has the same active and inactive ingredients in the same amounts as the original drug it copies.

Who It Affects

People and companies who submit or plan to submit generic drug applications to the government.

Key Provisions

• When someone requests information or when the government reviews a generic drug application, officials must tell them whether the drug is qualitatively and quantitatively the same as the original drug (meaning it has the same ingredients in the same amounts). (Sec. 2(a)) • If the generic drug is NOT the same as the original drug, officials must identify which ingredients are different and tell the applicant the exact amount of any ingredient that differs in quantity. (Sec. 2(a)) • Once officials determine a generic drug IS the same as the original drug, they cannot change or take back that decision after the company submits its application, unless the original drug's formula changed and was removed for safety or effectiveness reasons, or officials discover they made an error. (Sec. 2(a)) • If officials decide to change their determination because of an error, they must give the person requesting information a written explanation. (Sec. 2(a)) • Within one year of this law taking effect, the government must issue written guidance explaining how it will determine whether a drug is qualitatively and quantitatively the same as the original drug, including how it will evaluate pH adjusters (substances that balance acidity). (Sec. 2(b))

What Changes

Generic drug applicants will receive clear written information about whether their proposed drug matches the original drug in ingredients and amounts. Officials must also follow a specific process when issuing guidance about how they make these determinations.

Important Definitions

None defined.

Effective Date

The new requirements begin on the date this law is signed, regardless of when the government finishes its guidance. (Sec. 2(c))

II 118TH CONGRESS 1ST SESSION S. 775 To provide for increased transparency in generic drug applications. IN THE SENATE OF THE UNITED STATES MARCH 14, 2023 Ms. HASSAN (for herself and Mr. PAUL) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To provide for increased transparency in generic drug applications. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Increasing Trans- 4 parency in Generic Drug Applications Act’’. 5 SEC. 2. INCREASING TRANSPARENCY IN GENERIC DRUG 6 APPLICATIONS. 7 (a) IN GENERAL.—Section 505(j)(3) of the Federal 8 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is 9 amended by adding at the end the following: 10 VerDate Sep 11 2014 01:12 Mar 23, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S775.IS S775 kjohnson on DSK79L0C42PROD with BILLS 2 •S 775 IS ‘‘(H)(i) Upon request (in controlled correspondence 1 or otherwise) by a person that has submitted or intends 2 to submit an abbreviated application under this subsection 3 for a drug that is generally required by regulation or rec- 4 ommended in guidance to contain the same inactive ingre- 5 dients in the same concentration as the listed drug re- 6 ferred to or for which there is a scientific justification that 7 an in vitro approach can be used to demonstrate bio- 8 equivalence based on certain qualitative or quantitative 9 criteria with respect to an inactive ingredient, or on the 10 Secretary’s own initiative during the review of an applica- 11 tion under this subsection for such a drug, the Secretary 12 shall inform the person whether such drug is qualitatively 13 and quantitatively the same as the listed drug. 14 ‘‘(ii) If the Secretary determines that such drug is 15 not qualitatively or quantitatively the same as the listed 16 drug, the Secretary shall identify and disclose to the per- 17 son— 18 ‘‘(I) the ingredient or ingredients that cause the 19 drug not to be qualitatively or quantitatively the 20 same as the listed drug; and 21 ‘‘(II) for any ingredient for which there is an 22 identified quantitative deviation, the amount of such 23 deviation. 24 VerDate Sep 11 2014 01:12 Mar 23, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S775.IS S775 kjohnson on DSK79L0C42PROD with BILLS 3 •S 775 IS ‘‘(iii) If the Secretary determines that such drug is 1 qualitatively and quantitatively the same as the listed 2 drug, the Secretary shall not change or rescind such deter- 3 mination after the submission of an abbreviated applica- 4 tion for such drug under this subsection unless— 5 ‘‘(I) the formulation of the listed drug has been 6 changed and the Secretary has determined that the 7 prior listed drug formulation was withdrawn for rea- 8 sons of safety or effectiveness; or 9 ‘‘(II) the Secretary makes a written determina- 10 tion that the prior determination must be changed 11 because an error has been identified. 12 ‘‘(iv) If the Secretary makes a written determination 13 described in clause (iii)(II), the Secretary shall provide no- 14 tice and a copy of the written determination to the person 15 making the request under clause (i). 16 ‘‘(v) The disclosures required by this subparagraph 17 are disclosures authorized by law, including for purposes 18 of section 1905 of title 18, United States Code.’’. 19 (b) GUIDANCE.— 20 (1) IN GENERAL.—Not later than one year 21 after the date of enactment of this Act, the Sec- 22 retary of Health and Human Services shall issue 23 draft guidance, or update guidance, describing how 24 the Secretary will determine whether a drug is quali- 25 VerDate Sep 11 2014 01:12 Mar 23, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S775.IS S775 kjohnson on DSK79L0C42PROD with BILLS 4 •S 775 IS tatively and quantitatively the same as the listed 1 drug (as such terms are used in section 2 505(j)(3)(H) of the Federal Food, Drug, and Cos- 3 metic Act, as added by subsection (a)), including 4 with respect to assessing pH adjusters. 5 (2) PROCESS.—In issuing guidance under this 6 subsection, the Secretary of Health and Human 7 Services shall— 8 (A) publish draft guidance; 9 (B) provide a period of at least 60 days for 10 comment on the draft guidance; and 11 (C) after considering any comments re- 12 ceived and not later than one year after the 13 close of the comment period on the draft guid- 14 ance, publish final guidance. 15 (c) APPLICABILITY.—Section 505(j)(3)(H) of the 16 Federal Food, Drug, and Cosmetic Act, as added by sub- 17 section (a), applies beginning on the date of enactment 18 of this Act, irrespective of the date on which the guidance 19 required by subsection (b) is finalized. 20 Æ VerDate Sep 11 2014 01:12 Mar 23, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\S775.IS S775 kjohnson on DSK79L0C42PROD with BILLS

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