Provision Hidden in the Consolidated Appropriations Act May Ban Off-Label Use of Pharmaceuticals

By Pam Memmer

A known method to pass unpopular legislation, Congress often slips an unrelated provision inside a large bill. By tucking the legislation into a huge bill and then forcing a vote without allowing time for Representatives, Senators, or citizens to read the bill, they have been able to whittle away at our freedoms over the years. Unbeknownst to most citizens, the Consolidated Appropriations Act, 2023 (H.R. 2617), signed into law on December 29, included legislation which could outlaw off-label use of pharmaceuticals. The bill version passed by the House was 4155 pages long. The version signed into law is 1653 pages, likely due to removal of unpassed amendments and changes to font and formatting, but still large enough to be impossible to fully read in a few days. The change, deeply embedded on page 1376, gives the FDA authority to ban off-label use of medical devices. Some believe this could extend to pharmaceuticals, others thing that could never happen. This legislation was requested by the FDA in response to a defeat in the 5th Circuit US Court of Appeals in 2021. The FDA banned the use of electrical stimulation devices to treat aggressive or self-injurious behavior only, not for other uses such as addiction or inappropriate sexual behaviors following traumatic brain injuries. The 5th Circuit agreed with the petitioners, who argued this was a violation of 21 USC §396, which prohibits the FDA from regulating the practice of medicine.

Allowing the FDA to regulate the practice of medicine by allowing them to ban off-label use of medical devices under law may soon lead to more FDA interference in the doctor-patient relationship. The pandemic proved to all of us how far bureaucrats will twist laws and regulations to exert control. We have also seen how the Affordable Care Act has allowed insurance companies and Big Pharma to work together to tie the hands of practitioners. In my corner of Indiana, practitioners still will not, or cannot, prescribe Ivermectin to treat anything other than parasites. If you can obtain a prescription, the local pharmacies will not fill the prescription. If you can find a practitioner to prescribe it and a pharmacy to fill it, you must pay cash for both because health insurance will not cover it. Now that the bureaucracy has seen what they could do to demonize Ivermectin and force practitioners into only using high-cost, brand-name pharmaceuticals to maximize big pharma profits, which low-cost, legacy medication is next?

Medications are frequently used off-label, as often as 1 in 5 prescriptions, to treat a variety of conditions. Banning off-label use could be catastrophic. Off-label use of medications is common in the treatment of narcolepsy, seizure disorders, Parkinson’s disease, and many other neurological conditions. CFS/ME (commonly known as chronic fatigue syndrome) is only treated with medications used off-label as there are no current FDA-approved medications. The antibiotic Erythromycin is often used in pediatrics to “to increase stomach motility and tolerance of oral feeding…Clinical use followed by randomized controlled trials established the off-label use of tricyclic antidepressants such as nortriptyline and desipramine as first-line treatments of neuropathic pain. Other antidepressants, such as amitriptyline and trazodone, are prescribed off label as sleep aids. Rituximab, a lymphoma drug, is used off label to treat a benign disorder, immune thrombocytopenia.” wrote Dr. Joel Zinberg of the Paragon Health Institute in his WSJ Op-Ed. Off-label use is the “standard of care” in fields where many patients have tried everything else without relief, such as oncology, rheumatology, and pain management.

We cannot replace the wisdom of an educated and experienced medical practitioner with bureaucratic rule-making by people who have never treated a patient. No two people are alike, and no two situations are exactly the same. The practice of medicine cannot be black or white. We must allow practitioners and their informed patients to decide treatments, not the government.

References
Connolly et al. (2022, December 29). H.R. 2617 – Consolidated Appropriations Act, 2023. Retrieved from Congress.gov: https://www.congress.gov/bill/117th-congress/house-bill/2617/text

Piper, G. (2023, February 28). Not just ivermectin: New FDA authority to ban off-label uses alarms doctors. Retrieved from Just the News: https://justthenews.com/government/federal-agencies/not-just-ivermectin-new-fda-authority-ban-label-uses-alarms-doctors

The Judge Rotenberg Educational Center, Inc. v. United States Food and Drug Administration, et al., No. 20-1087 (United States Court of Appeals, Fifth Circuit July 6, 2021). Retrieved from https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/pdf/USCOURTS-caDC-20-01087-0.pdf

Zinberg, J. (2023, January 12). The FDA Wants to Interfere in the Practice of Medicine. Wall Street Journal. Retrieved from https://www.wsj.com/articles/the-fda-wants-to-interfere-in-the-practice-of-medicine-physicians-patients-medical-devices-treatment-11673562165