I run a medical practice built almost entirely around treating obesity by video. Labs, history, follow-up — all possible through a screen.
And yet I’ve never written a prescription for a compounded GLP-1.
Both of those things are true because good telemedicine doesn’t cut corners. It’s past time for the FDA to enforce that by cracking down on the online sellers, stand-in prescribers, and bad actors exploiting compounding regulations.
The agency should issue guidance stating that cost is not a medical justification for compounding a drug, that a compounded GLP-1 is not a like-for-like substitute for an approved one, and that prescribing one without genuine medical necessity puts patients at risk and physicians’ licenses on the line.
And the prescribers fueling this compounding craze should stop. If you can’t name the medical reason your patient needs a knockoff GLP-1, you don’t have one.
Earlier this year, the FDA sent warning letters to 30 telehealth companies that blurred the line between approved and compounded GLP-1s in their ads. But vague admonishment doesn’t move the bottom line.
As demand for GLP-1s has surged, so has the market for compounded versions sold as quick, easy, lower-cost alternatives. To a patient, they can look nearly identical: similar names, similar claims, even similar injector pens. But they’re far from it.
Compounded drugs aren’t subject to the inspections and reviews that commercially manufactured medicines undergo. Some compounding pharmacies are excellent, following proper practices, issuing a certificate of analysis, running third-party testing. Others aren’t, and a patient ordering online through these quick-hit conglomerates has no way to know what version they’re injecting — if they’re even made aware of the difference first.
If a patient calls me about side effects a few weeks in, I need to know whether it’s the drug, the amount, or something that got added along the way. Without that gold-standard oversight, what’s in the vial may not match what’s on the label. Sterility failures and dosing errors have become reality.
Patients’ medical supervision shouldn’t stop at the first visit, either. Before I prescribe, I want to know about their history of diabetes, sleep apnea, an eating disorder, or any medications that might cause negative interactions. I track body composition over the course of treatment, because losing weight quickly without enough protein compromises muscle and bone.
Almost none of that is happening in these flashy online portals. A recent study of compounded GLP-1 sellers found next to no clinician involvement, and some orders cleared in under five minutes. That’s nothing more than commercial fulfillment.
Federal law lets pharmacies compound for an individual medical need — like an ingredient allergy or an inability to swallow a pill — and to fill temporary gaps during a shortage. When the GLP-1 shortages ended more than a year ago, sellers pivoted: Add a substance, usually vitamin B12, and market the product as personalized. No researcher has studied these combinations in people, and no reasonable person would consider that type of mass workaround a medical necessity.
I understand why this market exists. These medications are expensive, insurance coverage is inconsistent, and economic strain across the country feels unrelenting. I take that seriously, and I discuss every option with my patients.
We usually arrive at the same place: There’s no bargain for medicine when you can’t be sure what you’re getting.
Without official intervention, I’m worried the issue will soon worsen. An FDA advisory panel last month recommended adding six unapproved peptides to the list of substances that can be compounded in bulk — on almost no human evidence.
Until I see proof that a substance is safe and that it works, I won’t prescribe it. But without federal requirements, some companies won’t adhere to the same promise.
Telemedicine is tremendous for expanding patients’ access to experts, especially for chronic care, but a questionnaire is not a physician, and untested, unauthorized lookalikes are not medicines.
Doctors have a responsibility to hold that line. Regulators must, too.
The opinions expressed in Fortune.com commentary pieces are solely the views of their authors and do not necessarily reflect the opinions and beliefs of Fortune.
