The FDA and Vaccine Manufacturers Refuse to Show Us Their Work

• by David Gortler | Guest Writer

• Published February 12, 2024
• Opinion

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When it comes to mRNA injections for Covid, Americans are 100 percent dependent on the FDA and vaccine manufacturers to assess and confirm purity and consistency. That might be okay if the testing methodologies that manufacturers and the FDA were still fully transparent, but they’re not anymore.

Not only are the test results confidential, even the methodology used hasn’t been made public. The world just has to take manufacturers’ word that there’s no contamination or variability with the mRNA sequence or its lipid nanoparticle components—even though published epidemiology data indicate otherwise.

Secrecy abounds despite the vaccine manufacturers receiving billions of U.S. taxpayer dollars to conduct their R&D efforts. Transparency should be nonpartisan, especially when it comes to the quality of America’s pharmaceuticals.

On top of that, both the Trump and Biden administrations have proposed lifting Covid mRNA intellectual property rights for mRNA injections. Yet both the FDA and manufacturers are tightly protecting the ingredient information as proprietary/trade secret. But is it really appropriate to label it “proprietary/trade secret” if the research/development/product was funded with hundreds of millions of taxpayer dollars?

A transparent, publicly accountable FDA should be eager to prospectively test most or all of its regulated products for qualitative and quantitative consistency—and make those findings publicly available.

A transparent FDA would also share its testing methodology for mRNA Covid products for scientists who wish to confirm. But anyone trying to access this information will find it embargoed via an FDA report rendered useless by ludicrous redactions of not just the methodology, but the FDA’s critique of the methodology.

Without a list of ingredients or testing methodology, it is impossible for anyone else outside the FDA or manufacturers to know precisely how to check for product consistency. It is especially troublesome since new, preliminary data using independent methodology has produced troubling evidence of contamination in mRNA Covid product.

FDA’s Improper Quality Testing Methodology

Also troubling is the fact that in 2021, the FDA opted to start monitoring America’s pharmaceutical quality via a remote collection of “mailed-in” drug samples—a far less reliable process than testing samples directly collected at manufacturing plants or distribution points by FDA officials.

This “mail-in” sampling methodology is absurd. It would be akin to a state health department monitoring restaurants by requesting them to periodically mail in various items from their menu to be tested for potential food-born contamination or asking restaurants to promise to test the items themselves.

Lack of Specific Dosing Transparency Has No Precedence

Unlike every other FDA-approved pharmaceutical, including a previously approved RNA-based products including patisiran (Onpattro®), none of the Covid injections provide the sequence, molecular weight, and milligram strength on its official FDA package label. Normally, official FDA package labeling provides specifics of the actual ingredients in that volume, including the structure/sequence and specific concentration. That is not the case for Covid mRNA labels.

Look up whatever pharmaceuticals you can think of in the Drugs.com database, and you’ll see how all labels provide structure and/or molecular weight in their official package labeling. Covid mRNA shots are a conspicuous exception to the historical FDA approval practice and “truthful label” rule.

The study raises a number of critically important questions, which can’t begin to be answered without the consistency being verified beforehand—and “mail-in” sampling is not the way to do it.

Providing ingredient transparency and assuring quality via an appropriate sampling methodology is a core mission of the FDA. In fact, it was the primary reason for establishing the agency back in 1906. Americans today deserve complete transparency and improved quality control oversight when it comes to our pharmaceuticals. Our health may depend on it.

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This article was originally published by the Brownstone Institute. Dr. David Gortler, a 2023 Brownstone Fellow, is a pharmacologist, pharmacist, research scientist and a former member of the FDA Senior Executive Leadership Team who served as senior advisor to the FDA Commissioner on matters of: FDA regulatory affairs, drug safety and FDA science policy. He is a former Yale University and Georgetown University didactic professor of pharmacology and biotechnology, with over a decade of academic pedagogy and bench research, as part of his nearly two decades of experience in drug development. He also serves as a scholar at the Ethics and Public Policy Center.