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Consolidated Appropriations Act, 2026 › Section 6604

Extension of Authority to Issue Priority Review Vouchers to Encourage Treatments for Rare Pediatric Diseases

Section 6604 · Sec. 6604 ·

What this chapter is about

This part extends to September 30, 2029 the power to hand out vouchers that speed a drug review. It changes when the fee for using one is due. It also orders a study of whether the vouchers work, with a report in five years.

3 proposals indexed from this chapter.

The voucher authority runs to September 30, 2029

The document says “is amended”Who acts: CongressHow: statuteSec. 6604 in the PDF
What the document says

“Paragraph (5) of section 529(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking ``December 20, 2024, unless'' and all that follows through the period at the end and inserting ``September 30, 2029.''.”

Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, Sec. 6604

Subsection (a) of section 6604 amends section 529(b)(5) of the Federal Food, Drug, and Cosmetic Act, striking the words from December 20, 2024 to the end and inserting September 30, 2029.

What the document actually says

“Paragraph (5) of section 529(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking ``December 20, 2024, unless'' and all that follows through the period at the end and inserting ``September 30, 2029.''.”

Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, Sec. 6604
That sentence, in plain words

Cross out an old date and the words after it. Write in one date: September 30, 2029.

What this is about

A voucher lets a maker move a later drug to the front of the review line. It is a reward for working on rare diseases in children.

No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.

The priority review fee is due when the application is submitted

The document says “shall”Who acts: drug and biological product sponsorsHow: statuteSec. 6604 in the PDF
What the document says

“``(A) In general.--The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 505(b)(1) or section 351(a) of the Public Health Service Act for which the priority review voucher is used. All other user fees associated with the human drug application shall be due as required by the Secretary or under applicable law.''.”

Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, Sec. 6604

Subsection (b) of section 6604 replaces section 529(c)(4)(A) of the Federal Food, Drug, and Cosmetic Act. The priority review user fee is due when the application for which the voucher is used is submitted, and other user fees are due as the Secretary or other law requires.

What the document actually says

“``(A) In general.--The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 505(b)(1) or section 351(a) of the Public Health Service Act for which the priority review voucher is used. All other user fees associated with the human drug application shall be due as required by the Secretary or under applicable law.''.”

Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, Sec. 6604
That sentence, in plain words

The fee for a fast review is due when the application goes in. Other fees are due as the health chief or other law says.

What this is about

A fast review costs the agency more work. The maker pays for it. This says the money comes at the start.

No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.

A study of whether the vouchers work is due, with a report in five years

The document says “shall”Who acts: Comptroller General of the United StatesHow: statuteSec. 6604 in the PDF
What the document says

“The Comptroller General of the United States shall conduct a study of the effectiveness of awarding rare pediatric disease priority vouchers under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff), as amended by subsection (a), in the development of human drug products that treat or prevent rare pediatric diseases”

Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, Sec. 6604

Subsection (c) of section 6604 requires the Comptroller General to study how effective the vouchers have been. The study must cover the indications for each drug that won a voucher and was approved, whether an unmet need was met, the size of the company that won a voucher and of the one that used it, the voucher's value if transferred, which drugs vouchers were used for, the time between award and use, whether companies were motivated by the vouchers, whether the vouchers sped patient access, their effect on the agency's workload and priorities, and other incentives in federal law. The report is due to two committees within five years of enactment.

What the document actually says

“The Comptroller General of the United States shall conduct a study of the effectiveness of awarding rare pediatric disease priority vouchers under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff), as amended by subsection (a), in the development of human drug products that treat or prevent rare pediatric diseases”

Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, Sec. 6604
That sentence, in plain words

A watchdog office must study whether these vouchers work. The question is whether they lead to drugs for rare diseases in children.

What this is about

A voucher can be sold to another company. So it has a price. The study looks at that and at whether new drugs actually came of it.

No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.

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What This Page Covers, and What It Leaves Out

The three things the section does: extend the voucher authority, replace the user fee payment provision, and require a study of the vouchers' effectiveness with its twelve listed contents and a report within five years.

The twelve study contents listed one by one. They are recorded in summary.

The section amends the Federal Food, Drug, and Cosmetic Act, which is not indexed here, so how a priority review voucher works is not recorded on this site.