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Consolidated Appropriations Act, 2026 › Section 6603

Fda Report on Prea Enforcement

Section 6603 · Sec. 6603 ·

What this chapter is about

This part adds two things to a report the drug agency already files. One is a check on whether deadlines set in delays were met. The other is a list of penalties and settlements, with the drug, the sponsor and the amount.

2 proposals indexed from this chapter.

The report must evaluate compliance with deferral deadlines

The document says “is amended”Who acts: CongressHow: statuteSec. 6603 in the PDF
What the document says

“in paragraph (11), by striking the semicolon at the end and inserting ``, including an evaluation of compliance with deadlines provided for in deferrals and deferral extensions;'';”

Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, Sec. 6603

Section 6603 amends section 508(b)(11) of the Food and Drug Administration Safety and Innovation Act to add an evaluation of compliance with the deadlines set in deferrals and deferral extensions.

What the document actually says

“in paragraph (11), by striking the semicolon at the end and inserting ``, including an evaluation of compliance with deadlines provided for in deferrals and deferral extensions;'';”

Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, Sec. 6603
That sentence, in plain words

Write in words about deadlines. The report must check whether the ones set in delays were met.

What this is about

A maker can be given more time for a required study. That comes with a new deadline. The report must now say whether those were met.

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 report must list penalties, settlements and payments by drug and sponsor

The document says “is amended”Who acts: CongressHow: statuteSec. 6603 in the PDF
What the document says

“``(17) a listing of penalties, settlements, or payments under section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353) for failure to comply with requirements under such section 505B, including, for each penalty, settlement, or payment, the name of the drug, the sponsor thereof, and the amount of the penalty, settlement, or payment imposed.''.”

Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, Sec. 6603

Section 6603 adds a new paragraph (17) requiring the report to list penalties, settlements and payments under section 303 of the Federal Food, Drug, and Cosmetic Act for failing to meet the section 505B requirements, giving for each one the name of the drug, its sponsor and the amount.

What the document actually says

“``(17) a listing of penalties, settlements, or payments under section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353) for failure to comply with requirements under such section 505B, including, for each penalty, settlement, or payment, the name of the drug, the sponsor thereof, and the amount of the penalty, settlement, or payment imposed.''.”

Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, Sec. 6603
That sentence, in plain words

The report must list every penalty and settlement for these failures. For each one it must give the drug, the maker and the sum.

What this is about

A count of penalties says little on its own. Naming the drug and the maker shows who was fined and how much.

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 two things the section does: add the evaluation of compliance with deferral deadlines to paragraph (11), and add a new paragraph (17) listing penalties, settlements and payments.

The mechanical amendments moving the word and and a period between paragraphs.

The section amends the Food and Drug Administration Safety and Innovation Act, which is not indexed here, so what else the report contains is not recorded on this site.