The FDA gets a power up, doctors get intimidated, and we get screwed

Because of the 20 or so GOP members of the House of Representatives who held back on just handing Kevin McCarthy (R-CA) the speakership , a rule change was made to how the House writes and processes a bill. This came in the aftermath of the latest omnibus appropriations bill that was passed late last year. It was over 1600 pages long, and members had merely hours to peruse it before being forced to vote on it. The new rule basically says that amendments to a proposed bill can only be related to the bill in question. So if a bill is about funding college tuition for children of fallen soldiers, then a member cannot attach an amendment seeking funds for “research” into why pigs have sex.

I am old enough to remember a similar situation happening back in the late 2000s, when Barack Hussein Obama was president. The bill that has come to be known as Obamacare was several thousand pages long, and members had little time to look through it before voting on it as well. Nancy Pelosi, when asked what some of the provisions in the bill were, famously stated: “We have to pass the bill before we know what is in it.” I am no civics expert, but I am pretty sure that that is not how it is supposed to work.

Fast forward to 2022, and we found ourselves in a similar situation. The aforementioned appropriations bill included some stuff that really had nothing to do with appropriations. One such item is giving the FDA the power to prohibit off-label uses for medical devices. According to Just The News, this new provision was “buried” in page 3,542 of a 4,155-page bill draft. I do not know why they are referencing the Senate’s draft, when it is the final bill that was passed into law that matters; the final bill was shy of 1700 pages, and the referenced changes to Title 21 are on page 1376. It is worth noting, too, that the language in the online version of the law has not been changed as of the time of this writing as prescribed by H.R. 2617.

Title 21 U.S. Code § 360f(a) currently reads:

Whenever the Secretary finds, on the basis of all available data and information, that—

(1) a device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury; and

(2) in the case of substantial deception or an unreasonable and substantial risk of illness or injury which the Secretary determined could be corrected or eliminated by labeling or change in labeling and with respect to which the Secretary provided written notice to the manufacturer specifying the deception or risk of illness or injury, the labeling or change in labeling to correct the deception or eliminate or reduce such risk, and the period within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period;

he may initiate a proceeding to promulgate a regulation to make such device a banned device.

Title 21 U.S. Code § 360f(a) as of 02/23/2023

Let us add the new language where the omnibus bill calls for it:

Whenever the Secretary finds, on the basis of all available data and information, that—

(1) a device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury for one or more intended uses; and

(2) in the case of substantial deception or an unreasonable and substantial risk of illness or injury which the Secretary determined could be corrected or eliminated by labeling or change in labeling and with respect to which the Secretary provided written notice to the manufacturer specifying the deception or risk of illness or injury, the labeling or change in labeling to correct the deception or eliminate or reduce such risk, and the period within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period;

he may initiate a proceeding to promulgate a regulation to make such device a banned device or to make such intended use or uses a banned intended use or uses. A device that is banned for one or more intended uses is not a legally marketed device under section 1006 when intended for such use or uses

Amended law

All that lawyering pretty much means that if the FDA does not like how doctors are practicing medicine, or do not like how doctors are using a particular device outside the scope of its intended use, then the device can be banned by the FDA pursuant to a new regulation formulated on the spot by a non-elected bureaucrat. Of course, this will all be done for public safety, and not because Big Pharma wants to make more money. I would never dare to accuse the good people at the FDA to be in the pockets of Pfizer, Moderna, and their ilk. No sir. I have full faith and confidence in the FDA. Yup… After all, it is thanks to them that I learned that it is not just mammals than can produce milk.

There are doctors who are (rightfully) concerned that this is a precursor for the FDA to have actual authority over off-label use of medications, which is currently flimsy at best. Their authority on this was challenged at the height of the Wuhan flu pandemic, when viable (and cheap) treatments for this communist disease, like ivermectin, were interfering with Pfizer’s plan to develop a death jab… err “vaccine,” and other new (and not so cheap or viable) “treatments.” While the FDA could not outright ban the off-label use (flimsy authority, remember?), they did make it clear that pharmacies should not fill out those prescriptions, and with a wink and nod at the state licensing boards, said that doctors prescribing ivermectin to Wuhan flu patients were putting said patients in grave danger, thus encouraging licensing boards to revoke medical licenses for doctors who continued to prescribe ivermectin to effectively treat the Wuhan flu.

Intended or not, this change will intimidate doctors, discourage them from practicing medicine, and become nothing more than drug dealers with medical licenses pushing Big Pharma’s latest inventions. Remember, though, that H.R. 2617 was an appropriations bill, not a laws and regulations bill. Under the new House rules, such an amendment could not be attached to an appropriations bill, because changing a law has nothing to do with funding an agency. As usual, though, our government leaders are a day late and $30T short, and we get screwed.