FDA Opens Drug Fast Track With Approvals In As Little As 30 Days—Safety Oversight Under Fire

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The U.S. Food and Drug Administration (FDA) has launched a new fast-track drug approval program that could cut review times to just 30 days, raising alarms from watchdogs who warn the program may sacrifice safety for speed.

Drug review times can now be cut “from 10-12 months to just 1-2 months,” according to an agency press release.

The move comes after the U.S. House Committee on Energy and Commerce in October 2024 accused the FDA of “failing to meet safety requirements” and ignoring “important federal safety requirements to protect its employees and the public while also failing to prioritize scientific data quality.”

The Food and Drug Administration (FDA or Agency) is announcing the opportunity for a limited number of drug and biologic developers (“companies”) to participate in the FDA Commissioner’s National Priority Voucher (CNPV) pilot program. The CNPV pilot program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months. Announced in June 2025, this innovative program uses a collaborative tumor board style review process to accelerate approvals for companies aligned with critical U.S. national health priorities.

Flu Pandemic Orchestration

Significantly, FDA officials named “a universal flu vaccine that could provide broad protection against multiple strains of influenza, including those with pandemic potential,” as an example drug to be fast-tracked.

A so-called universal flu vaccine has long been a cornerstone of orchestrated pandemic preparedness plans, raising concerns that the FDA’s new fast track could be used to accelerate experimental influenza platforms under the guise of crisis prevention.

The government is now pouring $500 million into a universal bird flu vaccine platform—just as it waives oversight for gain-of-function research on the very H5N1 viruses it’s been engineering behind the scenes, echoing the same problem–reaction–solution playbook used during COVID.

The U.S. National Institutes of Health (NIH) has been systematically funding dangerous flu pathogen engineering—including lab-made bird flu viruses tested on live cows in Georgia, 100% lethal H5N1 constructs built in New York and Texas, drug-resistant bat-human hybrid influenza strains developed in Missouri, inflammation-enhancing influenza viruses created in China, over 200 synthetic “barcoded” COVID variants, and a reverse-engineered, mammal-adapted H5N1 virus made drug-resistant through serial passaging—while simultaneously advancing vaccine platforms to respond to the very threats it helped create.

In short, the same government agencies engineering pandemic-capable bird flu strains in the lab are now fast-tracking the vaccines they claim will save us from the crisis they’re manufacturing.

CNPV Pilot Program Specifics

FDA Commissioner Marty Makary, M.D., unveiled the CNPV program last month.

Selected companies will receive a voucher granting faster FDA review and enhanced communication.

Companies selected for the program will be issued a voucher entitling the company to benefits including enhanced communications and rolling review to allow for a shortened review time. The CNPV pilot program reflects the FDA’s broader commitment to create more efficient approval processes and modernize regulatory frameworks for greater agility to meet emerging public health needs.

The FDA claims authority for the program under its general powers granted by the FDCA and PHSA to review drug and biologic approval applications in line with its public health mission.

FDA’s authority for this program stems from its general authority to implement the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) consistent with its mission to promote and protect the public health, including with respect to review of applications submitted for approval for a drug under section 505 of the FDCA (21 U.S.C. § 355) or a biological product under section 351 of the PHSA (42 U.S.C. § 262).

Notably, the same Public Health Service Act now being cited to justify the FDA’s accelerated drug reviews was quietly extended in a stop-gap spending bill, where lawmakers concealed sweeping emergency powers that centralize authority, shield high-risk biolab research, and bypass traditional safety oversight under the guise of public health.

The FDA says the program will accomplish the following:

• “Faster review times (10-12 months vs. 1-2 months)”
• “Enhanced communication throughout the review process”
• “Multidisciplinary team-based evaluation”
• “Potential for accelerated approval if applicable requirements are met”
• “Maintains FDA’s rigorous safety and efficacy standards”

While the FDA has framed the CNPV program as a way to promote innovation and supply chain resilience, watchdogs argue the program gives a single commissioner the power to approve drugs with unprecedented speed and minimal oversight.

The FDA has not stated whether advisory committees or additional safety checks will be involved in the process.

With pandemic-era emergency powers quietly extended, gain-of-function influenza viruses still in active development, and a single FDA commissioner now able to greenlight fast-tracked drugs in as little as 30 days, the stage is set for another government-scripted crisis—this time, backed by pre-approved vaccines and no public debate.

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