H.R. 6485: Skinny Labels, Big Savings Act

119th Congress · introduced 2025-12-05 · Commerce · Latest: Referred to the House Committee on the Judiciary.

federal

Official title

Skinny Labels, Big Savings Act

Plain summary

Skinny Labels, Big Savings Act This bill provides a statutory safe harbor from patent infringement claims for generic or biosimilar manufacturers that seek or obtain approval for skinny labels of their drugs. Under current law, the Food and Drug Administration (FDA) may approve generic and biosimilar drugs through a process known as skinny labeling, which allows a generic manufacturer to seek approval only for approved uses of the drug that are no longer protected by patents. However, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. , a court held that a generic manufacturer may sometimes be liable for patent infringement when it markets skinny label generics. The bill specifically lists the following as actions that are not considered infringement of a method of use claim in a patent under the Federal Food, Drug, and Cosmetic Act: submitting or seeking approval of a skinny label for a generic or biosimilar drug; promoting or commercially marketing a drug with skinny labeling approved by the FDA; or describing a drug product approved by the FDA as a generic of, or therapeutically equivalent to, the branded drug. The bill also applies the safe harbor to similar actions under the Public Health Service Act.

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

Skinny Labels, Big Savings Act

Source: Congressional Research Service summary (Introduced in House)

AI explanation – may be wrong, check the official text

No AI explanation yet. It takes up to a minute to write and is then saved for everyone.

Limited to a few requests an hour per person.

The strongest published arguments

Arguments for (supporters)

Needs sources: no published arguments on this side yet. We only show items backed by a published source. Suggest one.

Arguments against (opponents)

Needs sources: no published arguments on this side yet. We only show items backed by a published source. Suggest one.

Alternatives

Needs sources: no published alternatives yet (for example a different bill, a law instead of an amendment, or keeping current law). We only show items backed by a published source. Suggest one.

Officials and money

Sponsor: Rep. Cline, Ben [R-VA-6] · 6 cosponsors

Money: No cost estimate published yet. No linked contracts or vendors yet.

Words on this page, explained (2)

Bill: A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).
Statute: A written law passed by a legislature. A statute can be changed by a later law; changing a constitution needs an amendment.

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Introduced in House)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-119hr6485.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/119/hr>

Record fed-us-cong119-hr6485 · catalog fed-us-congress-bills-cong119 · updated 2026-11-03 by psicol fed-bills