CONGRESSMAN
WASHINGTON — Rep. Ben Cline, R-Va., has introduced bipartisan legislation aimed at protecting the use of “skinny labels” in the generic drug market, a move he says will help lower prescription drug costs and preserve patient access to affordable medications.
Cline, who represents Salem, introduced the Skinny Labels, Big Savings Act alongside Rep. Zoe Lofgren, D-Calif. The bill is designed to ensure generic drugmakers can continue using skinny labels — an FDA pathway that allows approval of a generic or biosimilar drug for uses no longer covered by patents — without facing what supporters describe as abusive lawsuits from brand-name pharmaceutical companies.
“Families across Virginia and the nation are facing rising prescription drug prices that strain their budgets and put their health at risk,” Cline said in a statement. “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.”
Supporters of the bill say skinny labels speed up access to lower-cost alternatives while respecting valid patents. Cline said some brand-name manufacturers have increasingly used legal challenges to delay generic competition, undermining the intent of the pathway.
“For years, generic manufacturers have used skinny labels to lower drug costs without infringing on brand-name patents,” he said. “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 bill would shield generic drugmakers from method-of-use patent infringement claims when they follow federal law in obtaining FDA approval for skinny label uses. It also clarifies that companies can describe their products as FDA-approved therapeutic equivalents when consistent with FDA rules. Supporters say the measure maintains legitimate patent protections while strengthening a system meant to deliver savings to patients, insurers and taxpayers.
The legislation has already received backing from patient and consumer advocacy groups, including Patients for Affordable Drugs Now and the Campaign for Sustainable Rx Pricing.
“We have a prescription drug affordability crisis in this country,” Lofgren said. “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.”
John Murphy III, president and CEO of the Association for Accessible Medicines, also voiced support, saying skinny labeling has saved the health care system billions over the past four decades.
“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,” Murphy said.
-The Salem Times-Register
