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Keep your Eye on the Prize - CHD's Petition update....

Gemini said

The primary battleground is not "conspiracy," but administrative law and biochemical manufacturing standards. The FDA’s pushback against the December 2025 petition (FDA-2025-P-6831) and its recent "Refusal-to-File" (RTF) actions in 2026 center on a few critical, high-level objections.

1. The "Standard of Care" Objection

The Direct Quote:

"CBER does not consider the application to contain a trial 'adequate and well-controlled'... because your control arm does not reflect the best-available standard of care in the United States at the time of the study." — Dr. Vinay Prasad, CBER Director, Feb 2026.

The Explanation:

This is the FDA's most aggressive new posture. They are essentially accusing manufacturers—and by extension, the petitioners' target products—of "rigging" their clinical trials. The FDA argues that for a vaccine to be truly "safe and effective" for licensure, it shouldn't just be compared to a placebo (saltwater) or a "standard" dose. Instead, it must be tested against the best current treatment available (like a high-dose flu shot for seniors). By using a "substandard" comparator in trials, the FDA claims the resulting data is scientifically "inadequate" for a full Biologics License Application (BLA).

2. The "Semantic Reclassification" Objection

The Direct Quote:

"The petitioner’s request for reclassification relies on a misinterpretation of agency guidance... mRNA vaccines function as biologics, not gene therapies, due to the lack of genomic integration." — FDA Regulatory Response (Draft), 2026.

The Explanation:

CHD’s petition hinges on the Accardi Doctrine, which legally requires an agency to follow its own rules. CHD points to FDA guidance defining products that "transfer genetic material" as Gene Therapy. The FDA’s objection is a technical "firewall": they argue that "Gene Therapy" requires a permanent change to the host’s DNA. Since mRNA is "transient" (it disappears after a few days and doesn't enter the cell nucleus), the FDA contends it is exempt from the much stricter, multi-decade safety monitoring required for Gene Therapies.

3. The "Process 1 vs. Process 2" Manufacturing Objection

The Direct Quote:

"CBER reviews process and method validation consistent with a product lifecycle approach... minor manufacturing changes supported by data showing comparability [do not require] overly stringent and onerous comparability data." — FDA Guidance on Manufacturing Flexibilities, Jan 2026.

The Explanation:

This addresses Sasha Latypova’s core evidence. She argues that the "clean" batches used in trials (Process 1) were fundamentally different from the "mass-produced" batches given to the public (Process 2), which she claims were contaminated with residual DNA. The FDA’s objection is that they allow for "manufacturing flexibilities." They argue that as long as the manufacturer can show the end products are "comparable" enough, they don't need to redo the clinical trials. They view Latypova’s demand for new trials for every manufacturing change as "onerous" and unnecessary for public health.

4. The "Administrative Circumvention" Objection

The Direct Quote:

"The Citizen Petition process should not be used to circumvent the administrative order process... The proposed revocations should be rejected as they would inappropriately intervene in the practice of medicine." — FDA Notice of Action, late 2025.

The Explanation:

The FDA often objects to the format of these petitions. They argue that a Citizen Petition is meant for small, specific changes (like a warning label), not for the "summary revocation" of a multi-billion dollar license. They view the petition as an attempt to "short-circuit" the law. By framing the petition as a "political" or "practice of medicine" issue rather than a "safety" issue, the FDA can legally dismiss it without ever having to hold a public hearing on the actual manufacturing data.

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In this case the Judge is the Defendant it appears.

The FDA needs to recuse itself.

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