December 12, 2025
TOPLINE
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.
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.
Also, in case you missed, this past week, CSRxP submitted a comment letter 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 USPTO HERE.
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)
“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)
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 to STAT News, more than double the year prior.
TWEETS OF THE WEEK
@IMAKglobal: “’Patent reform is our best path forward for addressing a root cause of high drug prices in a bipartisan manner.’ - @realtahiramin”
@AccessibleMeds: “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
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
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
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
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.
###
