H.R. 7032 – Increasing Transparency in Generic Drug Applications Act of 2022

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Updated February 8, 2026 at 9:57 AM UTC

The bill amends the Federal Food, Drug, and Cosmetic Act to require the Health and Human Services Secretary to tell generic drug applicants whether their product is qualitatively and quantitatively the same as the reference listed drug. It aims to give applicants clearer information about any differences, helping them address issues earlier in the approval process. The rule applies to anyone submitting an abbreviated new drug application for a generic product.

Key Provisions

Adds a new requirement that, upon request or on the Secretary’s own initiative, the Secretary must inform a generic applicant if the proposed drug is qualitatively and quantitatively the same as the listed reference drug.
If the drug is not the same, the Secretary must disclose which ingredient(s) differ and the amount of any quantitative deviation.
If the drug is deemed the same, the determination cannot be changed after the application is submitted except if the reference drug’s formulation changes for safety/effectiveness reasons or if an error is identified; the Secretary must provide written notice of any change.
Mandates that HHS issue guidance within one year on how it will make these determinations, including a draft, a 60‑day public comment period, and final guidance.
The new requirements take effect on the date the law is enacted, regardless of when the guidance is finalized.

Legislative Activity

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2 earlier actions

HouseCommittee Latest Action

Referred to the Subcommittee on Health.

Health Subcommittee

March 10, 2022

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HouseIntro Referral

Introduced in House

March 9, 2022

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

March 9, 2022

HouseCommittee

Referred to the Subcommittee on Health.

Health Subcommittee

March 10, 2022

Bill Text

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Introduced in HouseIssued March 9, 2022

I

117th CONGRESS

2d Session

H. R. 7032

IN THE HOUSE OF REPRESENTATIVES

March 9, 2022

Ms. Kuster introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To amend section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) with respect to a process to inform persons submitting an abbreviated application for a new drug whether the new drug is qualitatively or quantitatively the same as a listed drug, and for other purposes.

1.

Short title

This Act may be cited as the Increasing Transparency in Generic Drug Applications Act of 2022.

2.

Determining whether proposed new generic drugs are qualitatively or quantitatively the same as the listed drug

(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 for a new drug under this subsection 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.

(ii)

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—

(I)

the ingredient or ingredients that cause the new drug not to be qualitatively or quantitatively the same as the listed drug; and

(II)

the quantity or proportion of any ingredient in the listed drug for which there is an identified quantitative deviation.

(iii)

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—

(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 under 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 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.

(2)

Process

In issuing guidance as required by paragraph (1), 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, 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.