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United States · Bill · HR

H.R. 4712 (116th)

Fairness in Orphan Drug Exclusivity Act

referredUnited States· United States Congress· EN

Introduced

17 October 2019

Last action

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Status

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

Sponsors

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Subjects

Discovery layer

Source updated

6 December 2025

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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 shall consider the sales of all drugs from the sponsor that have the same core molecule or ion that is responsible for the drug's physiological or pharmacological action.

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Documents

11 official files

Referred in Senate (text)

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