Press Releases

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.

“Families across Virginia and the nation are facing rising prescription drug prices that strain their budgets and put their health at risk,” said Congressman Cline. “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.”

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.

“Since the passage of Hatch-Waxman 40 years ago, skinny labeling has saved patients and the health care system billions of dollars annually,” said John Murphy III, President and CEO for the Association of Accessible Medicines. “Without hesitation, AAM applauds and supports legislation that will provide a safe harbor for skinny labeling, propelling patient access to lower-cost generic medications and protecting the overall health care system. Thank you to Representatives Cline and Lofgren for their hard work on behalf of patients.”