Enforcement is allowed only where due diligence was lacking
Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, section 6602, Sec. 6602.
Written by .
Enforcement is allowed only where due diligence was lacking
The document says “is amended”Who acts: CongressHow: statuteSec. 6602 in the PDF
What the document says
“by striking ``(except that the drug or biological product shall not be subject to action under section 303)'' and inserting ``(except that the drug or biological product shall be subject to action under section 303 only if such person demonstrated a lack of due diligence in satisfying the applicable requirement)''; and”
Subsection (a) of section 6602 amends section 505B(d)(2) of the Federal Food, Drug, and Cosmetic Act. Where the old words shut off action under section 303 entirely, the new words allow it, but only where the person showed a lack of due diligence in meeting the requirement.
What the document actually says
“by striking ``(except that the drug or biological product shall not be subject to action under section 303)'' and inserting ``(except that the drug or biological product shall be subject to action under section 303 only if such person demonstrated a lack of due diligence in satisfying the applicable requirement)''; and”
That sentence, in plain words
Cross out the words that ruled out any action. Write in words that allow it, but only if the maker did not try hard enough.
What this is about
A maker can be told to test a drug in children. Before, missing that carried no penalty of this kind. Now it can, if the maker did not really try.
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.
Consolidated Appropriations Act, 2026, Public Law 119-75, sec. 6602, 140 Stat. 698 (2026). https://www.govinfo.gov/content/pkg/PLAW-119publ75/html/PLAW-119publ75.htm
This page
“Enforcement is allowed only where due diligence was lacking,” Consolidated Appropriations Act, 2026, section 6602, Sec. 6602. Read the Mandate, https://readthemandate.org/consolidated-appropriations-act-2026/proposal/sec6602-due-diligence-test/ (retrieved October 10, 2026).
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