On Monday, U.S. Representatives Ben Cline (R-VA-06) and Zoe Lofgren (D-CA-18)
introduced the bipartisan Skinny Labels, Big Savings Act in the U.S. House. A
U.S. Senate companion bill (S.43) was introduced in January of this year.





 

December 12, 2025



TOPLINE



On Monday, U.S. Representatives Ben Cline (R-VA-06) and Zoe Lofgren (D-CA-18)
introduced the bipartisanSkinny Labels, Big Savings Act
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in the U.S. House. A U.S. Senate companion bill (S.43
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in January of this year.



The longstanding practice known as skinny labeling has fostered competition
for decades by helping more affordable generic and biosimilar alternatives to
high-priced brand name drugs enter the market. Skinny labeling has generated
substantial savings for patients, taxpayers and the health care system. But
recent legal challenges from Big Pharma have weakened this framework, creating
additional opportunities for brand name drug companies to delay and block more
affordable alternatives from reaching American patients.



The Skinny Labels, Big Savings Act would help ensure the policy functions as
Congress intended, preserving legitimate patent rights while preventing
anti-competitive abuse of the system that keeps drug prices high. Read more on
The Skinny Labels, Big Savings Act HERE
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.



Also, in case you missed, this past week, CSRxP submitted a comment letter
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to the director of the U.S. Patent and Trademark Office (USPTO) on December 2,
urging the USPTO to consider reforms that strengthen competition and
affordability within the patent system.



"As the U.S. Patent and Trademark Office (USPTO) considers changes to the U.S.
patent system, it is critical that such reforms strengthen – and not weaken –
competition and affordability,” the letter states. “Unfortunately, the Notice
of Proposed Rulemaking (NPRM) proposes a new standard for the institution of
Inter Partes Reviews (IPR) that would limit generic and biosimilar developers’
ability to file IPRs. The inevitable result is patients paying the high cost of
brand-name prescription drugs for longer than would otherwise occur today.”
Read CSRxP’s full comment letter to the USPTOHERE
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.



QUOTES OF THE WEEK



“For years, generic manufacturers have used skinny labels to lower drug costs
without infringing on brand-name patents, but now, some pharmaceutical
companies are exploiting legal loopholes to sue generic competitors and delay
their entry into the market. Our bill stops that abuse and restores fairness to
the system.”



U.S. Representative Ben Cline (R-VA-06)
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“We have a prescription drug affordability crisis in this country. Lawsuits
have eroded the ‘skinny label’ pathway and delayed the rollout of lower-cost
alternatives. With this bill, we are leveling the playing field and allowing
generic drug manufacturers to get their lifesaving prescription drugs to the
market faster, driving down costs for patients.”



U.S. Representative Zoe Lofgren (D-CA-18)
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DATA POINTS YOU SHOULD KNOW



$19 Billion



U.S. sales of Eli Lilly’s GLP-1 Drugs Mounjaro and Zepbound, in just the first
nine months of the year, according toSTAT News
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, more than double the year prior.



TWEETS OF THE WEEK



@IMAKglobal <[link removed]>:
“’Patent reform is our best path forward for addressing a root cause of high
drug prices in a bipartisan manner.’ - @realtahiramin”



@AccessibleMeds <[link removed]>
: “Our #AAM team released a statement today, in support of The Skinny Labels,
Big Savings Act, which was introduced in the U.S. House of Representatives.
‘Without hesitation, AAM applauds and supports legislation that will provide a
safe harbor for skinny labeling, accelerating patient access to lower-cost
generic medications and protecting our healthcare system,’ said John Murphy
III, President and CEO for the Association of Accessible Medicines. ‘Thank you
to Representatives @RepBenCline and @RepZoeLofgren for their hard work on
behalf of patients.’”



ROAD TO RECOVERY



The Ripon Advance: Arrington, Colleagues Urge Administration’s Support Of
ETHIC Act To Lower Drug Costs
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The U.S. Department of Commerce should prioritize addressing the issue of
patent thickets surrounding branded pharmaceutical products, particularly
biologics, as a critical pro-competition reform, according to U.S. House Budget
Committee Chairman Jodey Arrington (R-TX) and a bipartisan group of lawmakers.
Patent thickets are a strategic tool used by branded pharmaceutical companies
to extend market exclusivity beyond the intended scope of patent law.



The Office of U.S. Representative Ben Cline: Cline Introduces Bipartisan Bill
To Protect Skinny Labels, Lower Drug Costs
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Rep. Ben Cline (R-VA), alongside Rep. Zoe Lofgren (D-CA), introduced the
Skinny Labels, Big Savings Act, a bipartisan bill to help lower prescription
drug costs by protecting generic drug makers from abusive lawsuits and
preserving patient access to affordable medications… The bill has earned the
backing of key patient and consumer advocacy organizations, including Patients
for Affordable Drugs NOW and the Campaign for Sustainable Rx Pricing.



Law360: Generic-Drug Group Backs House Bill On Skinny Labels
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An industry group representing the generic and biosimilar drug manufacturing
sector has applauded the introduction of a U.S. House of Representatives bill
titled The Skinny Labels, Big Savings Act, saying it will reduce prices across
healthcare. U.S. Reps. Ben Cline, R-Va., and Zoe Lofgren, D-Calif., introduced
the bill on Monday. The lawmakers said it's intended to lower drug prices and
defend generic drugmakers from abusive lawsuits through the use of so-called
skinny labels, which allow drugmakers to apply for U.S. Food and Drug
Administration approval only for approved uses of drugs that are no longer
protected by patents. The Association for Accessible Medicines said in a Monday
press release that the measure will ensure that the skinny label provisions in
the Hatch-Waxman Act of 1984 are not undermined.



PHARMA’S POOR PROGNOSIS



STAT News: Driven By GLP-1’s, Prescription Drug Spending Exploders At Major
Health Insurers
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Health insurance companies have lamented fast-rising medical expenses for more
than two years. This year is no different as Americans continue to get more
care than insurers expected. One of the main culprits of that higher spending:
prescription drugs, and GLP-1s in particular. Some insurers spent more on drugs
in the first nine months of this year than they did in all of 2024, financial
documents analyzed by STAT show. For many, drug expenses are up more than 20%
in 2025.



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