The will to power continues at the highest level of the federal government at a steady pace. It has been known for years that retired generals and admirals (the ones who spout duty, honor, country) are often hired by defense contractors after overseeing projects involving those companies products. That is one of the reasons large cost overruns are perpetrated on taxpayers: they know a low bid will be covered by extra costs paid for by changes in work orders or added specifications.

Now a news item reports that in the last two decades most former directors of the Food and Drug Administration work for pharmaceutical companies. The importance of this is evident with the power the FDA has over those companies. The 1992 Prescription Drug User Fee Act allowed the FDA to collect fees from the drug industry, changing it from a tax funded entity to one supplemented by industry money. Now, a huge portion of the agency budget comes from the industry the agency is supposed to regulate. In 1993 the FDA collected about $29 million, by 2016 $884 million and in 2022 $3 billion out of a budget of $6 billion. Does this money influence the FDA’s actions in any way? Does the offer to reduce a company’s fee have an impact? Does the prospect of a future job at a much larger salary have any influence on their actions? What do you think?

This is bad enough, but now a paragraph slipped into the 2023 omnibus appropriations bill should worry both patients and their physicians. The legislation amends the Food, Drug, and Cosmetic Act to give the FDA the authority to ban off-label uses of otherwise approved medications. This is a great threat since estimates are that up to 20% of drugs are beneficially used for off label problems. If the provision is passed, doctors’ ability to freely treat patients, and patients’ ability to use all available treatments after informed decisions may be lost.

The reason for this law is simple. Just as a recently enacted law in California gives that state expanded power to take away doctors’ medical licenses if they spread “misinformation” (even if accurate) that goes against the standard approved rhetoric, so the aim is to allow a federal government agency to silence your doctor and dictate more components of your medical care.

It is easy to imagine that a drug company may tell the FDA the off-label use of its cheap drug X is not approved for problem Y; instead you need to use their new very expensive drug Z. That very action has occurred with the COVID epidemic.

The new provision was enacted at the FDA’s urging, because barring a practitioner from prescribing or using an otherwise approved drug for a specific off-label indication would presently violate a section which bars the FDA from regulating the practice of medicine. The FDA is thus trying to change that. It’s another grab for power for the few, along with the impending U.S.-World Health Organization Strategic Dialogue accord allowing the compromised WHO dictatorial power over the world’s pandemic policies.

Thomas A. Modesto, MD,

Danville

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