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# FDA Should Meet Its Own Scientific Standards: Pitts
- URL: https://www.fdaweb.com/fda-should-meet-its-own-scientific-standards-pitts/
- Published: 2026-11-05T21:57:00.000Z
- Updated: 2026-11-06T02:56:53.000Z
- Author: David McFarland
- Tags: Drugs

Commenting on an Ascendis Pharma 10/6 [petition](https://downloads.regulations.gov/FDA-2026-P-12082-0036/attachment%5F1.pdf?ref=fdaweb.com) asking FDA to require additional information about BridgeBio’s infigratinib to resolve safety questions involving its potential indication to treat children with achondroplasia, Center for Medicine in the Public Interest president **Peter Pitts** says FDA should be held to the same scientific standards that the agency holds companies to. In his [comment](https://www.fdaweb.com/require-more-infigratinib-info-ascendis/), Pitts, a former FDA associate commissioner, says questions about holding FDA to scientific standards “take on particular urgency when the patients are children.”

He notes that in 2021, the agency adopted the International Council for Harmonization S11 guidance on nonclinical safety testing for pediatric pharmaceuticals. He says the guidance addressed a problem that has concerned pediatric drug development for decades — how to identify developmental risks before exposing children to medicines that may interfere with biological processes that scientists are still struggling to understand.

Pitts says the fact that the infigtratinib petition was submitted by a BridgeBio competitor doesn’t relieve FDA of its obligation to address legitimate scientific questions on their merits.

“None of this establishes that infigratinib causes neurological harm,” Pitts writes. “Nor does a citizen petition prove that a development program is deficient. The question is whether the agency has applied its own scientific framework and can explain why the available evidence is sufficient.”

The agency must retain flexibility to exercise scientific judgment in applying guidance documents, he says, particularly when new evidence or unusual clinical circumstances warrant a different approach. “But there is a substantial difference between exercising judgment and improvising a justification after the fact,” he adds.

Pitts concludes that parents shouldn’t have to choose between timely access to promising medicines and confidence that FDA has done its scientific homework. Nor, he says, should drug developers have to guess when the agency intends to follow its own guidance. “Scientific credibility isn’t established by issuing guidance documents,” he says. “It’s earned by applying them consistently, and explaining, with evidence, when a different approach is warranted. FDA wrote the rules of the road. It shouldn’t be the first to disregard them.”