S. 562: Ensuring Timely Access to Generics Act of 2021

117th Congress · introduced 2021-03-03 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

federal

Follow this bill, step by step

Where it came from: introduced 2021-03-03 · official record
Who proposed it: Sen. Shaheen, Jeanne [D-NH] · 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 Health, Education, Labor, and Pensions. 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

Ensuring Timely Access to Generics Act of 2021

Plain summary

Ensuring Timely Access to Generics Act of 2021 This bill imposes requirements related to third-party petitions concerning an application for Food and Drug Administration (FDA) approval to market a generic drug or biosimilar. (The current statute refers to these petitions as citizen petitions , which typically involve requests that the FDA take certain actions, such as requiring additional warnings on a drug.) Under the bill, the FDA may deny a citizen petition that (1) was submitted primarily to delay the approval of the relevant application, or (2) does not on its face raise valid scientific or regulatory issues. Currently, the FDA may deny a petition as an attempt at delay only if the petition meets both of these requirements. The bill also requires the FDA to establish procedures for referring such a delaying petition to the Federal Trade Commission. The bill also expressly requires a third party, before filing a lawsuit to force the FDA to set aside or prevent market approval of a generic drug or biosimilar, to first file a citizen petition with the information and arguments that form the basis of the lawsuit. A citizen petition must be filed within 60 days of when the filer knew or reasonably should have known the information that forms the basis of the petition.

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

Ensuring Timely Access to Generics Act of 2021

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. Shaheen, Jeanne [D-NH] · 3 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Bill Cassidy (R-LA), Michael F. Bennet (D-CO)

Sponsor's campaign money: Sen. Shaheen, Jeanne [D-NH] reported raising $176,810 (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 (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 Senate)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-117s562.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/117/s>

Record fed-us-cong117-s562 · catalog fed-us-congress-bills-cong117 · updated 2026-11-15 by psicol fed-bills-cong117