119th Congress · introduced in the Senate · Jan 9, 2025
Skinny Labels, Big Savings Act
Official title from Congress.gov
Latest action (Jan 9, 2025): Read twice and referred to the Committee on the Judiciary.
View on Congress.govPolicy area: Commerce
Congressional Research Service summary, version: Introduced in Senate (Jan 9, 2025)
Skinny Labels, Big Savings Act
This bill provides a statutory safe harbor from patent infringement claims for generic or biosimilar manufacturers that seek or obtain approval for skinny labels of their drugs.
Under current law, the Food and Drug Administration (FDA) may approve generic and biosimilar drugs through a process known as skinny labeling, which allows a generic manufacturer to seek approval only for approved uses of the drug that are no longer protected by patents. However, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a court held that a generic manufacturer may sometimes be liable for patent infringement when it markets skinny label generics.
The bill specifically lists the following as actions that are not considered infringement of a method of use claim in a patent under the Federal Food, Drug, and Cosmetic Act:
• submitting or seeking approval of a skinny label for a generic or biosimilar drug;
• promoting or commercially marketing a drug with skinny labeling approved by the FDA; or
• describing a drug product approved by the FDA as a generic of, or therapeutically equivalent to, the branded drug.
The bill also applies the safe harbor to similar actions under the Public Health Service Act.
Show less of the summaryIncludes 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.
Read twice and referred to the Committee on the Judiciary.
Introduced in Senate
Actions from Congress.gov, newest first.
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 24, 2026.
104 citations; showing the 25 most recently posted.
SANOFI US SERVICES INC · lobbying firm or registrant: SANOFI US SERVICES INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Copyright/Patent/Trademark
$1,250,000
Spent on own lobbying
S. 43: Skinny Labels, Big Savings Act; S. 2276 ETHIC Act; and Intellectual Property.
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
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Copyright/Patent/Trademark
$2,560,000
Spent on own lobbying
…60/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop…
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
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Health Issues
$2,560,000
Spent on own lobbying
…ine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---A…
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
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Medicare/Medicaid
$2,560,000
Spent on own lobbying
…turing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordabl…
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
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · lobbying firm or registrant: RADIUS ADVOCACY, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$30,000
Paid to lobbying firm
…cement Act. S.1041 - Affordable Prescriptions for Patients Act. S.2658 - Medication Affordability and Patent Integrity Act (MAPIA). S.1095 - Stop STALLING Act. S.43 - Skinny Labels, Big Savings Act.
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
FRESENIUS KABI USA LLC · lobbying firm or registrant: WILEY REIN LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$10,000
Paid to lobbying firm
H.R.3269/S.2276, Eliminating Thickets to Increase Competition (ETHIC) Act H.R.6485/S.43, Skinny Labels, Big Savings Act Issues related to pharmaceutical manufacturing Issues related to pharmaceutical patents
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
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · lobbying firm or registrant: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$7,040,000
Spent on own lobbying
S. 43: Skinny Labels, Big Savings Act S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096…
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
GSK (FKA GLAXOSMITHKLINE INC.) · lobbying firm or registrant: GSK (FKA GLAXOSMITHKLINE INC.)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$1,530,000
Spent on own lobbying
S. 43: Skinny Labels, Big Savings Act S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096…
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
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · lobbying firm or registrant: COVINGTON & BURLING LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$340,000
Paid to lobbying firm
Medication Affordability and Patent Integrity Act (S. 2658); Biopharmaceutical policy issues; Skinny Labels, Big Savings Act (S. 43/H.R. 6485).
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
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · lobbying firm or registrant: COVINGTON & BURLING LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$340,000
Paid to lobbying firm
…on Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Commun…
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
AMGEN INC · lobbying firm or registrant: AMGEN, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$3,150,000
Spent on own lobbying
…ct (PREVAIL) S. 1546/ HR 3152-- Patent Eligibility Restoration Act of 2025 (PERA) S 2276 / HR 3269 Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 43/HR 6485 Skinny Labels Big Savings Act S.2658 Medication Affordability and Patent Integrity Act S. 3452/HR 6624 Biological Intellectual Property Protection Act…
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
NOVARTIS · lobbying firm or registrant: NOVARTIS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$840,000
Spent on own lobbying
S. 43: Skinny Labels, Big Savings Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Ac…
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
FRESENIUS KABI USA LLC · lobbying firm or registrant: FRESENIUS KABI USA LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$630,000
Spent on own lobbying
…tion Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug En…
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
COUNCIL FOR INNOVATION PROMOTION (C4IP) · lobbying firm or registrant: COUNCIL FOR INNOVATION PROMOTION (C4IP)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$90,000
Spent on own lobbying
…R. 861 American Music Fairness Act of 2025 Proposed changes to address counterfeit use of trademarks, such as the SHOP SAFE Act introduced in the last Congress S. 43 / H.R. 6485 - Skinny Labels, Big Savings Act PTAB NPRM related issues
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 OF ACCESSIBLE MEDICINES (FORMERLY KNOWN AS GPHA) · lobbying firm or registrant: FIERCE GOVERNMENT RELATIONS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$60,000
Paid to lobbying firm
…- Ensuring Timely Access to Generics Act; S.1414 - Expedited Access to Biosimilars Act; S.1954 - Biosimilar Red Tape Reduction Act; S.3788 - Clear Labels Act; S.43 - Skinny Labels, Big Savings Act; Tariffs; General Business Issues.
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
THE CAMPAIGN FOR SUSTAINABLE RX PRICING · lobbying firm or registrant: MEHLMAN CONSULTING, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$90,000
Paid to lobbying firm
…ents Act. S.1096 - Preserve Access to Affordable Generics and Biosimilars Act. S. 1097/H.R. 4570 - Interagency Patent Coordination and Improvement Act of 2025. S. 43/H.R. 6485 - Skinny Labels, Big Savings Act. H.R. 3269/S. 2276 - Eliminating Thickets to Increase Competition (ETHIC) Act. H.R. 3160/S. 1533 - The Prevail Act.…
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 OF ACCESSIBLE MEDICINES · lobbying firm or registrant: MEHLMAN CONSULTING, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$60,000
Paid to lobbying firm
…ceutical manufacturing supply chain. S. 1040 - Drug Competition Enhancement Act; H.R. 5526/S. 1954 -Biosimilar Red tape Elimination Act; H.R. 3269 - ETHIC Act; S. 43 - Skinny Labels, Big Savings Act; H.R. 1843/S. 1302- Increasing Transparency in Generic Drug Applications Act; Country of origin labeling. H.R. 9661/S. 1414 -…
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
AMERICAN INTELLECTUAL PROPERTY LAW ASSOCIATION (AIPLA) · lobbying firm or registrant: AMERICAN INTELLECTUAL PROPERTY LAW ASSOCIATION (AIPLA)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 19, 2026 · issue area: Copyright/Patent/Trademark
$10,000
Spent on own lobbying
…ess to Affordable Generics and Biosimilars Act S. 1041, Affordable Prescriptions for Patients Act S. 708/H.R. 1574, RESTORE Patent Rights Act of 2025 H.R. 6485/S. 43, Skinny Labels, Big Savings Act Issues related to USPTO operations Issues related to international patent harmonization Issues related to patent subject matter…
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
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 17, 2026 · issue area: Copyright/Patent/Trademark
$770,000
Spent on own lobbying
…ility and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled…
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
KAISER FOUNDATION HEALTH PLAN INC · lobbying firm or registrant: KAISER FOUNDATION HEALTH PLAN INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 16, 2026 · issue area: Pharmacy
$500,000
Spent on own lobbying
…ds Drug Years Act (REMEDY Act) S.2276, H.R. 3269 - Eliminating Thickets to Increase Competition Act (ETHIC Act) S.3014 - Ensuring Timely Access to Generics Act S.43 - Skinny Labels, Big Savings Act
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
CAMPAIGN FOR SUSTAINABLE DRUG PRICING (CSRXP) · lobbying firm or registrant: WHITMER & WORRALL, LLC
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 22, 2026 · issue area: Copyright/Patent/Trademark
$50,000
Paid to lobbying firm
…Affordable Generics and Biosimilars Act. H.R. 3160 & S. 1533, the PREVAIL Act. S. 1546 & H.R. 3152, the Patent Eligibility Restoration Act of 2025. H.R. 6485 & S.43 Skinny Labels, Big Savings Act. S.1040 Drug Competition Enhancement Act. H.R. 3269 /S. 2276, Eliminating Thickets to Increase Competition (ETHIC) Act.
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
SANOFI US SERVICES INC · lobbying firm or registrant: SANOFI US SERVICES INC.
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 21, 2026 · issue area: Copyright/Patent/Trademark
$920,000
Spent on own lobbying
S. 43: Skinny Labels, Big Savings Act; S. 2276 ETHIC Act; and Intellectual Property.
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
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 21, 2026 · issue area: Copyright/Patent/Trademark
$2,360,000
Spent on own lobbying
…60/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop…
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
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 21, 2026 · issue area: Health Issues
$2,360,000
Spent on own lobbying
…ug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING…
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
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 21, 2026 · issue area: Medicare/Medicaid
$2,360,000
Spent on own lobbying
…turing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordabl…
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