PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the House Committee on Energy and Commerce.
Congressional Research Service
Version 00 · Introduced in House · Feb 6, 2025
This bill modifies provisions related to market exclusivity for a generic drug.
Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.
The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) the applicant certifies that there are no conditions that would prevent commercial marketing of the drug within 75 days of approval and that the applicant intends to do so, (3) a first applicant's application has been pending for at least 33 months, (4) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant, and (5) no first applicant's application has been effectively approved on the date that all such conditions are met.
Showing the opening paragraphs of the official summary.
If an applicant fails to begin commercially marketing their drug within 75 days of approval via the aforementioned process, the applicant's approval is deemed tentative and the applicant is no longer eligible for subsequent approvals, unless the applicant certifies that the failure was due to unforeseen issues that have since been resolved.
People & committees
Rep. Budzinski, Nikki [D-IL-13] · D–IL
Legislative record
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Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We also preserved the text version used in the PlainBill explanation below.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Jun 9, 2025. Consult Congress.gov for the current record.
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PlainBill explanation
Based on the full Introduced in House · 2025-02-06 text. This explanation has not received human editorial review. This overview describes the proposal’s major provisions; it does not establish what its real-world effects would be.
The bill would let certain later drug applicants receive approval through an abbreviated application process despite a first applicant's eligibility for a 180-day exclusive period. Later applicants would have to certify that they can and intend to begin commercial sales within 75 days. Missing that deadline could cause them to lose effective approval.
The Secretary may approve an application containing a certification described in paragraph (2)(A)(vii)(IV) that is for a drug for which a first applicant has submitted an application containing such a certification, notwithstanding the eligibility of a first applicant for the 180-day exclusivity period
there are no conditions that would prevent the applicant from commercial marketing within 75 days after the date of approval and that the applicant intends to so market the drug.
an application that is approved pursuant to subclause (III) of subparagraph (B)(iv) is deemed to be tentatively approved and to no longer have an effective approval pursuant to such subclause (III) beginning on the day after the end of the 75-day period specified in item (bb) of such subclause (III) if the applicant fails to commence commercial marketing as required under such item.
Section 1(a) would authorize, but not require, the Secretary to approve a qualifying later application despite a first applicant's eligibility for exclusivity. Both applications must contain the certification identified by the statutory cross-reference. The later application must otherwise be eligible for effective approval, and its applicant must certify readiness and intent to begin commercial sales within 75 days after approval.
The Secretary may approve an application containing a certification described in paragraph (2)(A)(vii)(IV) that is for a drug for which a first applicant has submitted an application containing such a certification, notwithstanding the eligibility of a first applicant for the 180-day exclusivity period described in subclause (II)(aa), if each of the following conditions is met:
(aa) The approval of such application could be made effective, but for the eligibility of a first applicant for 180-day exclusivity under this clause. (bb) The applicant of such application has submitted a certification to the abbreviated new drug application that there are no conditions that would prevent the applicant from commercial marketing within 75 days after the date of approval and that the applicant intends to so market the drug.
Additional eligibility conditions would require at least 33 months to have passed since at least one first applicant submitted an application for the drug. At least one first applicant's application must not be blocked from approval under the referenced clause (iii). No first applicant's application may have effective approval when all the other conditions are met and maintained.
(cc) At least 33 months have passed since the date of submission of an application for the drug by at least one first applicant. (dd) Approval of an application for the drug submitted by at least one first applicant is not precluded under clause (iii). (ee) No application for the drug submitted by any first applicant is effectively approved on the date that the conditions under items (aa), (bb), (cc), and (dd) are all met and maintained.
A same-day priority rule would protect a tentatively approved first applicant that has requested final approval. If that first applicant meets all approval requirements on the same day a later applicant becomes eligible under the new pathway, the later applicant could not receive effective approval until 180 days after the first applicant begins commercial sales.
If an applicant described in subclause (III) is eligible for effective approval on the same day a tentatively approved first applicant who has requested final approval is determined by the Secretary to be eligible for effective approval by meeting all the approval requirements of this subsection, such applicant may not receive effective approval until 180 days after the first applicant begins commercial marketing of the drug
Under section 1(b), an applicant approved through the new pathway that fails to begin commercial sales within 75 days would generally lose effective approval the following day. Its application would instead have tentative approval, meaning its approval would no longer be in effect under this pathway.
Except as specified in subclause (II), an application that is approved pursuant to subclause (III) of subparagraph (B)(iv) is deemed to be tentatively approved and to no longer have an effective approval pursuant to such subclause (III) beginning on the day after the end of the 75-day period specified in item (bb) of such subclause (III) if the applicant fails to commence commercial marketing as required under such item.
If an applicant notifies the government that it can no longer begin commercial sales within the 75-day period, its approval would become tentative and cease to be effective on the date that notification is received.
If the applicant of an application approved pursuant to subclause (III) of subparagraph (B)(iv) submits, pursuant to item (bb) of such subclause, a notification that it can no longer commence commercial marketing within the 75-day period specified in such item, such application is deemed to be tentatively approved and to no longer be effectively approved beginning on the date that such a notification is received.
An applicant that gives that notification and misses the 75-day deadline could regain effective approval under the new pathway only by meeting all its conditions again and making two additional certifications: an event it could not reasonably have foreseen prevented commercial sales, and it has fully resolved the resulting obstacles.
If an applicant described in item (aa) does not commence commercial marketing within such 75-day period, the applicant shall not be eligible for a subsequent effective approval for the application involved under subclause (III) of subparagraph (B)(iv) unless, in addition to meeting each of the conditions in such subclause (III), the applicant submits a certification to its abbreviated new drug application that— (AA) an event that could not have been reasonably foreseen by the applicant prevented it from commencing commercial marketing; and (BB) it has fully resolved any issues preventing such commercial marketing from commencing as a result of such event.
An applicant covered by the inability-to-market notification rule would have to submit confirmation of commercial sales to its abbreviated application no later than one business day after those sales begin.
An applicant described in item (aa) shall, not later than one business day after commencing marketing of the drug that is the subject of the application described in such item, submit a notification to the abbreviated new drug application confirming that such applicant has commenced commercial marketing of the drug.
Section 1(c) would limit these changes to abbreviated applications filed after enactment. The application must identify a listed drug for which no certification under the specified statutory provision was made before enactment.
The amendments made by subsections (a) and (b) shall apply only with respect to an application filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the date of enactment of this Act that identifies a listed drug for which no certification under paragraph (2)(A)(vii)(IV) of such section was made before such date of enactment.
The supplied actions snapshot, updated June 9, 2025, records introduction in the House and referral to the House Committee on Energy and Commerce on February 6, 2025.
Source snapshot updated 2025-06-09T17:58:46Z. 2025-02-06: Referred to the House Committee on Energy and Commerce. 2025-02-06: Introduced in House
A closer look
Reviewed version: Introduced in House · 2025-02-06. These findings describe provisions and who may benefit; they are not judgments of waste, corruption, or motive.
This review covers the supplied bill text. “None identified” does not rule out provisions in later versions or accompanying reports and disclosures.
Provisions outside the bill’s main subject, or policy changes attached to appropriations.
None identified in the reviewed text
No unrelated provision or policy change attached to appropriations was identified in the complete supplied introduced text. This conclusion is limited to that version.
Spending directed to particular recipients or places outside ordinary competitive or formula-based allocation.
None identified in the reviewed text
No congressionally directed spending for particular recipients or places was identified in the complete supplied introduced text. This conclusion does not establish absence in other versions or accompanying materials.
Narrow exceptions, exemptions, or preferential treatment that warrant a closer look.
None identified in the reviewed text
No materially narrow preferential benefit beyond the bill's general approval framework was identified in the complete supplied introduced text. Eligibility rules and related priority protections were assessed as parts of the main policy. This conclusion is limited to that version.
Full text preserved for this analysis. Legislative record snapshot: Jun 9, 2025. How PlainBill uses AI