Senator Collins, Bipartisan Group Reintroduce Bill to Safeguard Generic Drugs, Slash Drug Prices

Washington, D.C. – U.S. Senator Susan Collins joined Senators John Hickenlooper (D-CO), Tom Cotton (R-AR), and Peter Welch (D-VT) to reintroduce 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. Senator Collins and the same bipartisan group previously introduced the legislation in the 118th Congress.

“This bipartisan legislation will promote generic drug competition and improve patient access to lower-cost medications,” said Senator 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:

1. Submit or seek approval of a skinny label for a generic or biosimilar pharmaceutical product;
2. Label, promote, or commercially market, consistent with the Federal Food, Drug, and Cosmetic Act regulations, a drug with skinny labeling approved by the FDA; and
3. 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.

The complete text of the bill can be read here.

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