The FDA Succeeded in Interfering with the Practice of Medicine/ WSJ Op-Ed

A little-noticed provision of the omnibus spending bill gave the agency power to ban off-label use of approved therapies.

On December 29, 2022 President Biden signed the $1.7 Trillion “omnibus” government appropriations bill for fiscal year 2023, which funds the government through September 2023. It had been released to Congress on December 20. It was passed by Congress on December 22, 2022—a mere 2 days after being released.

It had 1,653 pages that almost no one read in the 2 days they had to consider the bill before voting.

Now, facts about what was in this bill are dribbling out and they are disconcerting, to say the least. Let me say clearly that I have not reviewed this bill (and can’t possibly do so) and am relying on what others have written. I believe these provisions are put in huge bills for multiple reasons, one being that ordinary humans cannot pick through them.

The law that allowed for the use of off-label licensed drugs like HCQ and IVM appears to have been neutered. Also gone is the prohibition for using EUA products outside an emergency, discussed in a previous substack and confirmed by Sanjoy Mahajan’s identifying the FDA notice dated Jan. 31 that confirms it.

It seems that the government’s stamping out the independent practice of medicine is marching forward in the dark, avoiding any public opposition. The below is from Dr. Mercola:

https://articles.mercola.com/sites/articles/archive/2023/02/04/new-laws-allow-pharma-make-decisions-patients.aspx

In the U.S., 1 in 5 prescriptions is written for an off-label use.¹ While sometimes this allows medications to be overused or misused, it also protects doctors' ability to freely treat patients, and patients' ability to use all available treatments after making an informed decision.

That 20% of medications are used off-label also indicates "a degree of freedom physicians currently have that will be foreclosed," notes English comedian and actor Russell Brand,² if a little-noticed provision in the omnibus spending bill is passed. "Literally, this will mean that your doctor will not be able to do what's best for you because they'll work for Big Pharma now," Brand says.³

19 Lines in 4,155-Page Bill Could Change Practice of Medicine

The 2023 omnibus appropriations bill — a 4,155-page tome involving $1.7 trillion in spending — includes 19 lines that could give the U.S. Food and Drug Administration the power to ban off-label use of approved medications. In a commentary for The Wall Street Journal, Dr. Joel Zinberg wrote:⁴

"Physicians routinely prescribe drugs and employ medical devices that are approved and labeled by the Food and Drug Administration for a particular use. Yet sometimes physicians discern other beneficial uses for these technologies, which they prescribe for their patients without specific official sanction.

The new legislation amends the Food, Drug and Cosmetic Act, or FDCA, to give the FDA the authority to ban some of these off-label uses of otherwise approved products. This unwarranted intrusion into the physician-patient relationship threatens to undermine medical innovation and patient care."