In a sneaky move, the FDA has extended its power over how doctors can practice medicine. Action Alert!
Doctors, be advised: the FDA is starting to regulate the practice of medicine. Buried in the 4,155 page spending bill Congress recently approved is the innocuous-sounding “Bans of Devices for One or More Intended Uses.” This dangerous provision allows the FDA to ban off-label uses of medical devices while leaving them approved for other uses. This provision expands the FDA’s power to dictate what your doctor can and can’t do. Today, it’s medical devices, but the FDA could easily use this as a precedent to further expand its power to regulate the practice of medicine and enforce a one-size-fits-all vision of medicine.
Off-label use of medicines and medical devices is a critical component of medicine. One in five prescriptions written are for off-label use—that is, when a doctor gives you a medicine approved by the FDA to treat a condition different than yours. Hundreds, if not thousands, of drugs are commonly prescribed for off-label uses. Here are some common examples. This is completely legal. The Food, Drug, and Cosmetic Act prohibits the FDA from limiting or interfering “with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease.” In simple language, the FDA is not allowed to interfere with the practice of medicine.
Off-label use of medical devices is also common, especially in pediatric populations, pregnant women, cancer patients, and patients with rare diseases, since companies are often not willing or unable to sponsor clinical trials to support claims for those uses. Pediatric off-label use of medical devices includes dilation balloons for pulmonary artery stenosis and valvar aortic stenosis, cutting balloons for pulmonary artery stenosis and creation of atrial septal defect, and radiofrequency perforation wire for perforation of atretic pulmonary valve.
The FDA’s role is to control which medications and devices are commercially available, not to limit or control how they are prescribed by physicians once the medications are on the market. A commentary in the Wall Street Journal encapsulates how important this is:
Off-label use enables physicians to assess their patients’ unique circumstances and use their own evolving scientific knowledge in deciding to try approved products for new indications. If the treatment proves useful, formal studies are performed and published. If enough evidence accumulates, the treatment becomes the standard of care, even if the manufacturer didn’t submit the product for a separate, lengthy and costly FDA review.
Off-label use is what allowed front line physicians to experiment with different approved medications (like hydroxychloroquine and ivermectin) for the treatment of COVID—with documented success.
It’s worth noting how this all came about. The FDA asked Congress for this change after it was blocked in court from banning certain off-label uses of medical devices. The court held that the FDA could ban a medical device altogether if it poses “an unreasonable and substantial risk of illness or injury,” but banning an off-label use of an approved device is regulating the practice of medicine and therefor prohibited. The FDA violated the law, so the agency turned to Congress to change it.
While the current policy change applies only to medical devices for now, we believe it is likely that the FDA will use this as a precedent to gain similar power over the off-label prescribing of drugs. The agency can then use this power to further the interests of Big Pharma. Keeping with the COVID example, the agency could have banned the off-label use of hydroxychloroquine and ivermectin—two generically available drugs that aren’t big money-makers—in an effort to get more people to receive the vaccines. Remember, as we’ve said many times, the FDA sees Big Pharma as its client. If the agency gains the ability to ban off-label uses of drugs, it can use this power to give blockbuster drugs that are about to come to market a boost by banning the off-label competition.
Consider, too, that intravenous vitamin C (IVC) is an FDA-approved drug for the treatment of scurvy. Intravenous vitamin C is widely used in the integrative medical community for a variety of conditions. The FDA could easily ban all off-label uses of IVC to eliminate one more form of competition for Big Pharma’s drugs.
This is the latest in what is becoming an onslaught on your doctor’s freedom to practice medicine as they see fit. We’ve seen a number of states introduce legislation that allows state medical boards to go after doctors for medical “misinformation,” which can of course be construed as anything that goes against current orthodoxies. California has approved one of these bills.
We cannot let the FDA gain more power over how medicine is practiced in this country.
Action Alert! Write to Congress and tell them to repeal this new policy that allows the FDA to regulate the practice of medicine. Please send your message immediately.