The required study may cover the drug used with another active ingredient
Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, section 6601, Sec. 6601.
Written by .
The required study may cover the drug used with another active ingredient
The document says “is amended”Who acts: CongressHow: statuteSec. 6601 in the PDF
What the document says
“the investigation described in this paragraph is a molecularly targeted pediatric cancer investigation of--
``(i) the drug or biological product for which the application referred to in such paragraph is submitted; or”
Section 6601 rewrites section 505B(a)(3)(A) of the Federal Food, Drug, and Cosmetic Act. The required investigation may cover the drug in the application, or that drug used with another active ingredient. The other ingredient must either have an approved generic or biosimilar application and be found by the Secretary, after consulting the applicant, to be part of the standard of care for a pediatric cancer, or have an approved application to treat an adult cancer held by the same applicant and be directed at a molecular target the Secretary finds substantially relevant to a pediatric cancer.
What the document actually says
“the investigation described in this paragraph is a molecularly targeted pediatric cancer investigation of--
``(i) the drug or biological product for which the application referred to in such paragraph is submitted; or”
That sentence, in plain words
The study must look at a drug aimed at a target in a cancer cell. It may look at the drug in the application on its own.
What this is about
Cancer in children is often treated with drugs used together. A study of one drug alone may not answer much. This lets the study cover the pairing.
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. 6601, 140 Stat. 695 (2026). https://www.govinfo.gov/content/pkg/PLAW-119publ75/html/PLAW-119publ75.htm
This page
“The required study may cover the drug used with another active ingredient,” Consolidated Appropriations Act, 2026, section 6601, Sec. 6601. Read the Mandate, https://readthemandate.org/consolidated-appropriations-act-2026/proposal/sec6601-combination-investigations/ (retrieved October 10, 2026).
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