ICYMI: SKINNY LABELS, BIG SAVINGS ACT INTRODUCED IN U.S. HOUSE
Bipartisan Solution Would Help Bring More Generics and Biosimilars to Market, More Quickly — Reverse Big Pharma Attempts to Erode Skinny Labeling Pathway
In case you missed it, the bipartisan Skinny Labels, Big Savings Act was introduced in the U.S. House this week by Representatives Ben Cline (R-VA-06) and Zoe Lofgren (D-CA-18). 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 from the U.S. House sponsors’ press release below:
“’The Skinny Labels, Big Savings Act is a commonsense solution that protects competition in the marketplace and ensures patients can get the medications they need at a price they can afford. By reinforcing a key pathway that brings safe, effective generics to market, we’re putting patients ahead of profit,’” said Congressman Cline.
“The legislation strengthens protections for the use of ‘skinny labels,’ a critical regulatory tool that allows generic and biosimilar manufacturers to seek FDA approval for uses of a drug that are no longer protected by patents. This pathway accelerates access to more affordable alternatives while respecting valid intellectual property rights.”
“’For years, generic manufacturers have used skinny labels to lower drug costs without infringing on brand-name patents,’ Cline continued. ‘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.’
“The Skinny Labels Big Savings Act ensures that generic manufacturers who obtain FDA approval for skinny label uses are not held liable for method-of-use patent infringement when operating by federal law. It also provides clarity that drugmakers can describe their generics as FDA-approved therapeutic equivalents, provided that description aligns with FDA regulations. Importantly, the bill reinforces that the use of skinny labels does not weaken legitimate patent rights, but rather supports a system that was designed to bring savings to patients, insurers, and taxpayers alike. 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.
“’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,’ said Rep. Zoe Lofgren.”
Read more about Big Pharma’s patent abuse HERE.
Read more on bipartisan, market-based solutions to hold Big Pharma accountable HERE.
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