United States 116th Congress Status: In Committee 1 R cosponsors

S 3271 — Fairness in Orphan Drug Exclusivity Act

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

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  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed Senate
  4. 4
    Passed House
  5. 5
    To Executive
  6. 6
    Enacted

This bill died with 116th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

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.

Bill Text

How this bill changes current law

6 changes Share ↗

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill introduces limitations on the exclusive approval or licensure of orphan drugs under specific conditions.

  • 21 U.S.C. 360cc

    Except as provided in subsection (b) → Except as provided in subsection (b) or (f)

    It expands the exceptions to include subsection (f) regarding orphan drugs.

  • 21 U.S.C. 360cc

    (f) Limitations on Exclusive Approval, Certification, or License.--

    It adds a new subsection (f) that sets forth limitations on exclusive approvals for orphan drugs.

  • 21 U.S.C. 360cc

    For a drug designated under section 526 for a rare disease or condition pursuant to the criteria set forth in subsection (a)(2)(B) of such section, the Secretary shall not grant, recognize, or apply exclusive approval or licensure under subsection (a)...

    It prohibits the Secretary from granting exclusive approval unless specific cost recovery criteria are met.

  • 21 U.S.C. 360cc

    ...unless the sponsor of the application for such drug demonstrates...

    It requires sponsors to demonstrate reasonable expectations regarding cost recovery to secure exclusivity.

  • 21 U.S.C. 360cc

    consider sales from all drugs that...are developed or marketed by the same sponsor...

    It expands criteria for exclusivity to consider sales of related drugs by the same sponsor.

  • 21 U.S.C. 360cc

    No drug designated under section 526 for a rare disease or condition...shall be eligible for exclusive approval...

    It establishes specific criteria for drugs seeking exclusivity based on their designation date.

Action History

  1. Introduced in Senate

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

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

healthcare health-insurance
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Frequently asked questions

What does S 3271 do?
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.
Who sponsors S 3271?
S 3271 is sponsored by Cassidy, Bill (Republican).
What is the current status of S 3271?
This bill died with 116th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track S 3271?
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