moreisdifferent.blog/p/a-laundry-list-of-possible-fda-reforms
3 corrections found
they do not use rolling reviews.
This is incorrect: the FDA does use rolling review in some expedited programs. FDA’s own materials describe rolling review as an available feature of Fast Track and related pathways.
Full reasoning
FDA explicitly says it uses rolling review in certain expedited review pathways.
On FDA’s Fast Track Designation Request Performance page, the agency states that "Fast track adds to existing programs ... the possibility of a 'rolling review' for an application." That directly contradicts the blanket claim that FDA does not use rolling reviews at all.
FDA also explains on its Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review page that Fast Track is one of the agency’s formal approaches for expediting review of drugs for serious conditions. In other FDA guidance for these programs, rolling review is part of that expedited framework.
So while the FDA may not have used the exact same review setup as every foreign regulator in every COVID vaccine case, the categorical statement that it "do[es] not use rolling reviews" is false.
2 sources
- Fast Track Designation Request Performance | FDA
Fast track adds to existing programs, such as accelerated approval, the possibility of a "rolling review" for an application.
- Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review | FDA
The Food and Drug Administration has developed four distinct and successful approaches to making such drugs available as rapidly as possible ... Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
delay Pfizer’s Emergency Use Authorization (EUA) from early November to December 11th
This timeline is wrong. Pfizer said on November 9, 2020 that the FDA-required safety milestone would not be reached until the third week of November, and Pfizer did not submit its EUA request until November 20.
Full reasoning
The article claims FDA delayed Pfizer’s EUA from early November to December 11, 2020. But the public record shows an early-November EUA was not actually available.
- In Pfizer’s November 9, 2020 press release, the company said its EUA submission was planned only after the required safety milestone was reached, and that this milestone was expected in the third week of November.
- FDA’s vaccine EUA explanation likewise said an EUA submission was expected to include a median follow-up of at least 2 months after completion of the full vaccination regimen.
- Pfizer then announced on November 20, 2020 that it was submitting its EUA request that day.
- FDA issued the EUA on December 11, 2020.
Because Pfizer itself said the FDA-required safety milestone would not be reached until the third week of November, and because the EUA request was not submitted until November 20, there was no EUA that the FDA could have granted in early November. That makes the claimed delay window inaccurate.
4 sources
- Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study | Pfizer
Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.
- Emergency Use Authorization for Vaccines Explained | FDA
FDA expects an EUA submission will include ... phase 3 data will include a median follow-up of at least 2-months ... after completion of the full vaccination regimen.
- Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine | Pfizer
Friday, November 20, 2020 ... they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA).
- FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine
Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine ... The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.
the decisions that pushed Pfizer's EUA from early November to late December
This Pfizer timeline is inaccurate. Pfizer said on November 9 that the FDA-required safety milestone would not be reached until the third week of November, and the company did not submit its EUA request until November 20; the EUA was then issued on December 11, not in late December.
Full reasoning
This sentence misstates the Pfizer vaccine EUA timeline.
Pfizer said publicly on November 9, 2020 that it planned to seek EUA only after the required safety milestone was reached, and that the milestone was expected in the third week of November. Pfizer then announced on November 20, 2020 that it was submitting its EUA request that day. FDA issued the EUA on December 11, 2020.
So the EUA was not something the FDA had available to grant in early November, because Pfizer had not yet met the relevant safety milestone or submitted the request. And the authorization date was December 11, which is not late December.
3 sources
- Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study | Pfizer
Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.
- Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine | Pfizer
Friday, November 20, 2020 ... they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA).
- FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine
U.S. Food and Drug Administration sent this bulletin at 12/11/2020 09:41 PM EST ... Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine ... The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.