Big Pharma Windfall: FDA Formalizes Handover of Natural Hormones and Other Biologicals

The Food and Drug Administration (FDA) is currently finalizing its handoff of all things natural to Big Pharma. They are issuing a “Vaccines, Blood & Biologics” guidance, in which they are taking control of all hormones and substances naturally found in your body and nature—and handing them over to Big Pharma.

The FDA’s Methods

First, the FDA redefined natural products as drugs. We’ll use pregnenolone, a bio-identical hormone used by women to prevent early deliveries, to show their process:

• The FDA attacked compounding pharmacies for selling pregnenolone, which had always been in their purview.
• The FDA labeled it an “orphan drug”.
• Once they had illegally stopped the sales of bio-identical hormones by compounding pharmacies, they handed the business over, granting exclusive rights to a single pharmaceutical corporation.
• The company, KV Pharmaceutical, immediately put their version of pregnenolone on the market at a price 15,000% higher than it had been sold by compounding pharmacies!

The FDA clearly was not acting for the benefit of the public. They stole a safe, natural, and needed product that was used by thousands of pregnant women to prevent early deliveries, and handed it over to Big Pharma. As a result, most of those thousands of women are no longer able to access pregnenolone. Gaia Health documented the story in FDA Bans Product from Compounding Pharmacies, Then Hands Exclusive Rights to Single Pharma Company.

Pregnenolone was a test run. Now, the FDA has codified the whole process.

You say that the FDA isn’t a law-making body? That they don’t legally have the authority to make laws? That’s how it’s supposed to be—but it bears little resemblance to what’s happening.

The FDA’s Purpose

By the cunning act of declaring something natural to be a drug, and then acting on that claim, the FDA has created an entirely new area of business for Big Pharma.

The impossibility of obtaining a patent for the exclusive sale of natural products no longer matters. The FDA has done an end-run around it.

The FDA has saved Big Pharma’s neck. They were in deep trouble. Their patents were reaching the end of their run.  Very few new drugs were in the pipeline. The best they were able to do was try to find new uses for old drugs—a tactic they’re still engaged in. Now, though, with guaranteed sole access to products that have been around forever, are well known and safe, Big Pharma has a new lease on life.

Who does the FDA work for? It was supposed to be us, but there was never much truth in that idea. It was just an image to get the public to go along with restrictions on their access to natural health products so that chemical-based ones could be crammed down their throats—literally. The FDA lives for the benefit of its masters: Big Pharma and Agribusiness.

 

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