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S. 3271: Fairness in Orphan Drug Exclusivity Act

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S. 3271: Fairness in Orphan Drug Exclusivity Act

116th Congress · introduced 2020-02-11 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2020-02-11 · official record
  2. Who proposed it: Sen. Cassidy, Bill [R-LA] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. 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.
  5. 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

Fairness in Orphan Drug Exclusivity Act

Plain summary

Fairness in Orphan Drug Exclusivity Act This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.) Specifically, when determining whether to grant an exclusivity period to a drug that has orphan status due to low expected sales, the FDA must consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.

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

Fairness in Orphan Drug Exclusivity Act

Source: Congressional Research Service summary (Introduced in Senate)

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The strongest published arguments

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

Officials and money

Sponsor: Sen. Cassidy, Bill [R-LA] · 2 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Tammy Baldwin (D-WI), Jeanne Shaheen (D-NH)

Sponsor's campaign money: Sen. Cassidy, Bill [R-LA] reported raising $6.7 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 (1)
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).

Plain meanings written from linked sources. All words.

Sources

Record fed-us-cong116-s3271 · catalog fed-us-congress-bills-cong116 · updated 2026-11-15 by psicol fed-bills-cong116