# 116-hr-4712: Fairness in Orphan Drug Exclusivity Act

116-hr-4712, Fairness in Orphan Drug Exclusivity Act, is a 116th Congress bill sponsored by Rep. Dean, Madeleine [D-PA-4] (D-PA); status Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (as of 2025-11-18).

- Canonical: https://policyrisk.com/legislation/116-hr-4712
- As of: 2025-11-18
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 116-hr-4712
- Congress: 116
- Title: Fairness in Orphan Drug Exclusivity Act
- Status: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Introduced: 2019-10-17
- Sponsor: Rep. Dean, Madeleine [D-PA-4] (D-PA)
- Cosponsors: 7
- Policy area: Health
- Touches household money: no
- Last recorded action: 2025-11-18

## 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.

## Cosponsors (7)

- Rep. Veasey, Marc A. [D-TX-33] (D-TX), 2019-10-17T00:00:00.000Z
- Rep. Carter, Earl L. "Buddy" [R-GA-1] (R-GA), 2019-10-17T00:00:00.000Z
- Rep. McKinley, David B. [R-WV-1] (R-WV), 2019-10-17T00:00:00.000Z
- Rep. Tonko, Paul [D-NY-20] (D-NY), 2019-12-05T00:00:00.000Z
- Sen. Kim, Andy [D-NJ] (D-NJ), 2020-07-16T00:00:00.000Z
- Rep. Soto, Darren [D-FL-9] (D-FL), 2020-08-04T00:00:00.000Z
- Rep. Taylor, Van [R-TX-3] (R-TX), 2020-11-16T00:00:00.000Z

## Related bills

- 116-hr-2423: Women's Suffrage Centennial Commemorative Coin Act
- 116-hr-1865: Further Consolidated Appropriations Act, 2020
- 116-hr-1379: Ensuring Lasting Smiles Act
- 116-hr-748: CARES Act
- 116-hr-7642: Coronavirus Economic Relief for Transportation Services Act
- 116-hr-4104: Negro Leagues Baseball Centennial Commemorative Coin Act

## Sources
- [116-hr-4712 on Congress.gov](https://www.congress.gov/bill/116th-congress/house-bill/4712)

## Related
- [116-hr-2423: Women's Suffrage Centennial Commemorative Coin Act](https://policyrisk.com/legislation/116-hr-2423)
- [116-hr-1865: Further Consolidated Appropriations Act, 2020](https://policyrisk.com/legislation/116-hr-1865)
- [116-hr-1379: Ensuring Lasting Smiles Act](https://policyrisk.com/legislation/116-hr-1379)
- [116-hr-748: CARES Act](https://policyrisk.com/legislation/116-hr-748)
- [116-hr-7642: Coronavirus Economic Relief for Transportation Services Act](https://policyrisk.com/legislation/116-hr-7642)
- [116-hr-4104: Negro Leagues Baseball Centennial Commemorative Coin Act](https://policyrisk.com/legislation/116-hr-4104)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/116-hr-4712 (as of 2025-11-18).