Bill paves the way for more generic drugs to come to market
WASHINGTON – Today, U.S. Senators John Hickenlooper, Tom Cotton, Peter Welch, and Susan Collins introduced the bipartisan Skinny Labels, Big Savings Act, a bill designed to lower drug prices by accelerating the roll-out of generic drugs and creating legal protections from endless lawsuits for generic drug manufacturers who obtain “skinny label” FDA approvals.
“Big pharma uses endless patent litigation to squeeze patients and stop competitors from coming into the market,” said Hickenlooper. “Our bill levels the playing field so generic drug manufacturers can help working people afford life-saving medication.”
“Generic drugs lower costs and provide options for patients. Our legislation will ensure more of them come to market by clarifying generic companies that comply with FDA requirements are not subject to unnecessary lawsuits,” said Cotton.
“In Vermont and across the country, hardworking families are burdened with astronomical health care costs–including for lifesaving prescription drugs. So-called skinny labeling has helped level speed generics to market, bringing down costs in the process. It’s no surprise Big Pharma has a big problem with it,” said Welch. “This bill will protect skinny labeling and help patients pay less at the pharmacy counter.”
“This bipartisan legislation will promote generic drug competition and improve patient access to lower-cost medications,” said Collins. “By reaffirming the so-called ‘skinny label’ pathway, this bill will help patients and taxpayers save money on prescription drugs.”
Brand-name drug manufacturers often use groups of patents to establish ownership over their drug and reduce market competition. These patents make it difficult to bring generics to market, resulting in higher drug costs for patients. To help speed up generic competition, federal law permits the Food and Drug Administration (FDA) to approve generic and biosimilar drugs via a “skinny label” that leaves out indications – uses of the drug – that are still protected by patents. Hickenlooper’s bill would protect generic drug manufacturers who obtain FDA approval for skinny label indications from liability in patent infringement cases.
Specifically, the bill would amend the federal patent infringement law so that generic drug manufacturers would be lawfully able to:
- Submit or seek approval of a skinny label for a generic or biosimilar pharmaceutical product;
- Labeling, promoting, or commercially marketing, consistent with the Federal Food, Drug, and Cosmetic Act regulations, a drug with skinny labeling approved by the FDA;
- Describe, consistent with the Federal Food, Drug, and Cosmetic Act, a drug approved via skinny label as a generic of or therapeutic equivalent to the branded drug.
Full text of the bill is available HERE.
A one-page explainer on the bill is available HERE.
“The Generics Access Project, a coalition of patient advocacy groups across disease states, applauds Senator Hickenlooper, Senator Cotton, Senator Collins, and Senator Welch for their proactive efforts to protect the skinny labeling of generic medicines – a critical pathway that has enabled timely patient access to high quality, affordable treatments for 40 years. Millions of patients rely on generic drugs that have been lawfully approved by the FDA with skinny labels. This safe harbor amendment is essential to ensuring the continued availability of generic medicines, ensure new generics are developed and helping bring affordable medicines to patients.”
“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 Senators Hickenlooper, Cotton, Welch, and Collins, as well as the committees of jurisdiction for their hard work on behalf of patients.”
“CSRxP commends Senators Hickenlooper, Welch, Cotton and Collins for highlighting the importance of protecting and fostering robust competition from more affordable alternatives to high-priced brand name prescription drugs. Their legislation would help strengthen and protect the use of skinny labels that substantially reduce barriers to entry for generic drugs and save patients and the U.S. health care system billions of dollars — preventing Big Pharma from gaming the system to undermine the full value of this critical pathway,” said Lauren Aronson, Executive Director of Campaign for Sustainable Rx Pricing.
“The Skinny Labels, Big Savings Act preserves a crucial pathway for ensuring patients can continue to access affordable, life-saving generic medicines at prices they can afford,” said Merith Basey, Executive Director of Patients For Affordable Drugs NOW. “Major drug corporations routinely abuse the patent system to extend their monopolies, block competition and set exorbitant prices that harm patients. This legislation provides a counterweight by codifying legal protections for skinny labeling into law. It maintains incentives for generic entry by shielding skinny labels from patent challenges, increasing savings for patients and taxpayers. We urge Congress to pass this pro-competition, pro-patient bill – to keep reining in Big Pharma’s pricing abuses.”
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