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# House Passes Pediatric/Rare Disease Bill
- URL: https://www.fdaweb.com/house-passes-pediatric-rare-disease-bill/
- Published: 2024-09-24T12:00:00.000Z
- Updated: 2026-09-14T14:42:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157843

The U.S. House of Representatives 9/23 passed the [Give Kids a Chance Act](https://www.congress.gov/bill/118th-congress/house-bill/3433/text?ref=fdaweb.com) (HR 3433) that is intended to address childhood cancer and rare diseases. The bill was introduced by Reps. **Michael McCaul** (R-TX) and **Anna Eshoo** (D-CA).

According to an Eshoo [news release](https://eshoo.house.gov/media/press-releases/eshoo-bill-improve-pediatric-drugs-passes-house-unanimously?ref=fdaweb.com), the measure would:

- Reauthorize FDA’s rare pediatric disease priority review voucher program through fiscal year 2029\.
- Require the agency to establish an inspection office in the Middle East.
- Allow HHS to collect registration fees and distribute these fees to support the operation of the Organ Procurement and Transplantation Network.

Additionally, the bill included Rep. **Doris Matsui**’s (D-CA) Retaining Access and Restoring Exclusivity (RARE) Act, which is intended to ensure that promising options for rare disease patients with no approved therapies are able to come to market without being blocked by other pharmaceutical companies. “With less than 5% of rare diseases having FDA-approved therapies, we need all the help we can get to ensure rare disease patients can access the cutting-edge care they need,” Matsui says in a [news release](https://matsui.house.gov/media/press-releases/house-passes-matsuis-rare-act?ref=fdaweb.com).

Matsui says her RARE Act is written to “prevent pharmaceutical companies from abusing their orphan drug status to keep other innovative drugs from coming to market… Specifically, the RARE Act clarifies FDA’s longstanding interpretation of the Orphan Drug Act to ensure that the scope of the orphan drug exclusivity applies only to the same approved use or indication within such rare disease or condition, instead of the same disease or condition. This will give FDA the necessary authority to approve the same drug from different manufacturers if they aim to serve different patient populations.”

The text of the RARE Act is available [here](https://matsui.house.gov/sites/evo-subsites/matsui.house.gov/files/evo-media-document/MATSUI%5F042%5Fxml.pdf?ref=fdaweb.com).