S. 3271 · 116th Congress
Fairness in Orphan Drug Exclusivity Act
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Never voted on. It didn't reach a floor vote before the 116th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
CassidySponsor2 cosponsors · 2 D
2 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA).
What it does: CRS summary · Introduced in Senate · Feb 11, 2020
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Fairness in Orphan Drug Exclusivity Act
Latest action (Feb 11, 2020): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Feb 11, 2020
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.