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S 3271 116th Congress Senate Health Competition and antitrust Drug safety, medical device, and laboratory regulation Licensing and registrations Marketing and advertising Prescription drugs

Fairness in Orphan Drug Exclusivity Act

Introduced: February 11, 2020 Introduced by: Cassidy, Bill Republican · Louisiana See on congress.gov
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This bill died when the 116th Congress ended
It never became law before the 116th Congress (2019–2020) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Feb 11, 2020
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Feb 11, 2020
Introduced in Senate
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 Plain-English summary Congressional Research Service

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.

What's happening now February 11, 2020

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Related & companion bills 1
  • HR 4712 Related bill Fairness in Orphan Drug Exclusivity Act
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Cosponsors 2
All 2 Democratic 2
D
Baldwin, Tammy
Wisconsin · Feb 11, 2020
 D
Shaheen, Jeanne
New Hampshire · Feb 11, 2020
Cite this page click to expand
APA
U.S. Congress. (2026). S. 3271: Fairness in Orphan Drug Exclusivity Act. 116th Congress. Open America. https://openamerica.io/bill/116-S-3271/
MLA
"S. 3271: Fairness in Orphan Drug Exclusivity Act." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-S-3271/.
Bluebook (legal)
S. 3271, 116th Cong. (2026), https://openamerica.io/bill/116-S-3271/.
Markdown link
[S. 3271: Fairness in Orphan Drug Exclusivity Act](https://openamerica.io/bill/116-S-3271/)
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