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# Senators Introduce Skinny Label Generic Drug Bill
- URL: https://www.fdaweb.com/senators-introduce-skinny-label-generic-drug-bill/
- Published: 2025-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:49:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158416

Sens. **John Hickenlooper** (D-CO), **Tom Cotton** (R-AR), **Peter Welch** (D-VT), and **Susan Collins** (R-ME) have introduced legislation intended to lower drug prices by accelerating the rollout of generic drugs and creating legal protections from lawsuits from manufacturers who obtain FDA “skinny label” approvals. A [statement](https://www.hickenlooper.senate.gov/press%5Freleases/hickenlooper-cotton-welch-collins-introduce-skinny-labels-big-savings-act-to-safeguard-generic-drugs-slash-drug-prices/?ref=fdaweb.com) from Hickenlooper says the Skinny Labels, Big Savings Act “levels the playing field so generic drug manufacturers can help working people afford life-saving medication.”

Hickenlooper accuses branded drug companies of using “endless patent litigation to squeeze patients and stop competitors from coming into the market.”

The statement says that under federal law, FDA can approve generic and biosimilar drugs via a “skinny label” that omits indications that are still protected by patents. The new legislation would amend the federal patent infringement law to enable generic drug manufacturers to lawfully:

- submit or seek approval of a skinny label for a generic or biosimilar pharmaceutical product;
- label, promote, or commercially market, consistent with the Federal Food, Drug, and Cosmetic Act (FFDCA) regulations, a drug with skinny labeling approved by FDA; and
- describe, consistent with the FFDCA, a drug approved via skinny label as a generic or therapeutic equivalent to the branded drug.