S. 64: Preserve Access to Affordable Generics and Biosimilars Act

116th Congress · introduced 2019-01-09 · Health · Latest: Read twice and referred to the Committee on the Judiciary.

federal

Follow this bill, step by step

Where it came from: introduced 2019-01-09 · official record
Who proposed it: Sen. Klobuchar, Amy [D-MN] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Read twice and referred to the Committee on the Judiciary. Not final yet: this can still change. We check for updates every day.
If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Preserve Access to Affordable Generics and Biosimilars Act

Plain summary

Preserve Access to Affordable Generics and Biosimilars Act This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar. An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects. When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations. The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

Congressional Research Service summary (Introduced in Senate), 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

Preserve Access to Affordable Generics and Biosimilars Act

Source: Congressional Research Service summary (Introduced in Senate)

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The strongest published arguments

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Sen. Klobuchar, Amy [D-MN] · 7 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Chuck Grassley (R-IA), Joni Ernst (R-IA), Kevin Cramer (R-ND), Richard J. Durbin (D-IL), Chris Van Hollen (D-MD), Susan M. Collins (R-ME)

Sponsor's campaign money: Sen. Klobuchar, Amy [D-MN] reported raising $2.5 million (2025–2026). Details. Shown for context only; it does not mean any donor supported this bill.

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (3)

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).
Exemption: A rule that removes certain people, property or activities from a tax or requirement.
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 Senate)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-116s64.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/116/s>

Record fed-us-cong116-s64 · catalog fed-us-congress-bills-cong116 · updated 2026-11-15 by psicol fed-bills-cong116