Part 2: The Greatest Game the DoD Ever Played

Ok, let’s get back to Terry.

Refresher.

There are two glaring issues that can be found in this memo.

  1. Claims that the EUA and licensed vaccines are “interchangeable” and EUA vaccines should be used “as if” they are the licensed product
  2. Referencing an FDA Q&A page as official guidance

Words matter.

Interchangeable. That is a pretty innocuous word most of the time, but when it comes to medical products it has a regulatory and a legal definition. Just like the laws regulating Biologics, “interchangeable” products have to meet certain conditions to be designated as such. In fact, it’s in the very same law! The Public Health Service Act was amended in 2009 to include to the Biologics Price Competition and Innovation Act. This created an abbreviated pathway to approval and licensure for interchangeable products. The idea of this amendment was to allow drug companies to produce more affordable options for biologic products, similar legislation exists for generic drugs known as the Hatch-Waxman Act, which this amendment was derived from.

Back to interchangeability, for any product to have an “interchangeable” it has to first have a reference product. The reference product is an already FDA approved biologic that a product is compared to in order to determine potential interchangeability. The FDA defines an interchangeable as, “an interchangeable product is a biosimilar product that meets additional requirements outlined by the Biologics Price Competition and Innovation Act. As part of fulfilling these additional requirements, information is needed to show that an interchangeable product is expected to produce the same clinical result as the reference product in any given patient.”

So what is a biosimilar? FDA defines it as, “A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.”

The most important aspect of interchangeability is the fact that both the interchangeable product and the reference product must be FDA approved. In the case of the Pfizer-BioNTech vaccine, Comirnaty is the FDA approved product and the Pfizer-BioNTech EUA labeled vaccine retains only its authorization.

Excerpt from the PHSA:

Suddenly, I am just curious what the FDA has to say about these two legally distinct vaccines interchangeability. The PurpleBook is the FDA’s biological resource, and provides us some insight into this designation.

Well, shoot. Shoot Shoot Shoot.

So what Terry Adirim has done is create a policy to mandate an EUA vaccine. This is wildly outside the scope of her authority since we know that the mandating of an EUA product is limited to the authority of the President of the United States per 10 USC 1107a. Not only did she create an unlawful policy, but she bastardized the reading of FDA guidance. Where she states that healthcare providers should, FDA guidance states can. Is she a liar, deceptive or simply incompetent?

I would guess all 3.

The only legal way the Pfizer-BioNTech vaccine is interchangeable with the licensed product, is if you have already given your consent to receive an EUA product.

Full Stop.

But let’s put a finer point on this absolute deceit. In the recently released Pfizer documents submitted to the FDA for approval, this lil nugget was just hanging out.

So what you’re saying is that for 4 years no one can even submit an application that uses the Pfizer vaccine as the reference product? And 12 years before an interchangeable could even be approved? Bye bye legal interchangeability claim.

Oh! And don’t think I forgot about point 2! The main issue here is that this is an informal Q&A page that is not legally binding in any way, yet Terry Adirim treated it as gospel and willy nilly violated the rights of service members. That is all.

But all those lawsuits put the DoD in a scramble to make this look legal, enter in the completely made up regulatory term “BLA Compliant.”

See ya tomorrow!

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Responses

  1. Wow this is amazing … I can’t see the docs in the examples within the article…are they on the documents page ? Either way awesome info and writing