119th Congress · introduced in the House · Feb 6, 2025
To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.
Official title from Congress.gov
Latest action (Feb 6, 2025): Referred to the House Committee on Energy and Commerce.
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: 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.
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.
No cosponsors.
Includes amendment, cloture, and procedural votes. Each is labeled with its exact question; only a passage question is a vote to pass the bill.
No recorded roll calls on this bill in coverage.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Actions from Congress.gov, newest first.
Drug safety, medical device, and laboratory regulation · Prescription drugs
LD-2 reports whose issue descriptions explicitly cite this bill (bill type and number validated against Congress.gov records). A citation does not establish the client's position or any contact with a member.
Loading lobbying reportsCoverage: reports for 2025 onward, posted Jan 1, 2025 through Oct 23, 2026.
5 citations.
ASSOCIATION FOR ACCESSIBLE MEDICINES · lobbying firm or registrant: ASSOCIATION FOR ACCESSIBLE MEDICINES
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Pharmacy
$870,000
Spent on own lobbying
…itted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASSOCIATION FOR ACCESSIBLE MEDICINES · lobbying firm or registrant: ASSOCIATION FOR ACCESSIBLE MEDICINES
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 20, 2026 · issue area: Pharmacy
$1,150,000
Spent on own lobbying
…scal Year 2026. S.1071 - National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASSOCIATION FOR ACCESSIBLE MEDICINES · lobbying firm or registrant: ASSOCIATION FOR ACCESSIBLE MEDICINES
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 20, 2025 · issue area: Pharmacy
$640,000
Spent on own lobbying
…Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASSOCIATION FOR ACCESSIBLE MEDICINES · lobbying firm or registrant: ASSOCIATION FOR ACCESSIBLE MEDICINES
2025 Q2 report (Apr 1, 2025 – Jun 30, 2025) · posted Jul 18, 2025 · issue area: Pharmacy
$650,000
Spent on own lobbying
….1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASSOCIATION FOR ACCESSIBLE MEDICINES · lobbying firm or registrant: ASSOCIATION FOR ACCESSIBLE MEDICINES
2025 Q1 report (Jan 1, 2025 – Mar 31, 2025) · posted Apr 16, 2025 · issue area: Pharmacy
$650,000
Spent on own lobbying
…l Revenue Code of 1986 to establish the generic drugs and biosimilars production credit, and for other purposes. Drug Shortages. Biosimilar Interchangeability. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing