Does Physician Prescription by Telemedicine Raise FDA Issues?
In today’s video, we look again at whether physician prescription by telemedicine is legal. But this time we are going to zoom in on FDA and FTC issues.
Hi everyone, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients just like you navigate healthcare and FDA legal issues so you can launch, or continue to scale, your health and wellness adventure.
Previously, on Cohen Healthcare Law Blog …. I just love saying that. I used to watch the show 24. All the time, like 24 and i always wanted to say: “previously….”
Well back to the present. Physician prescribing by telemedicine, and our focus now is on the telemedicine or telehealth platform. That could be you. In broad terms, this is a company managing and marketing the telemedicine services—with a big emphasis on marketing. Can’t sleep? Want bigger muscles? Lose weight? Increase your athletic or sexual performance? Look like a young Tom Cruise? Whatever it is, telehealth has answers for you. We connect you with the doctor and the medication. Presto.
We have helped hundreds of clients in this space. Over time, the laws regarding telemedicine licensing do tend to liberalize, but the doorway is in the details.
Previously, we’ve talked about issues around licensing, with physicians being in different states than the patients to whom they are prescribing. We’ve discussed the good faith appropriate prior examination, the issue of physician supervision, informed consent, HIPAA, corporate practice of medicine, anti-kickback, liability and risk management, and other such concerns. Now let’s turn to the FDA side.
FDA prohibits off-label promotion by drug manufacturers and distributors. So the question arises: Do telemedicine companies fall in the camp of distributors? A great question. And one of the important ones to the telemedicine company.
We also know that physicians can prescribe off-label, in fact, because FDA does not regulate individual practice of medicine by physicians. But what about the practice of standardizing and branding these kinds of prescriptions through the telehealth platform? Might this be considered misbranding under the federal Food, Drug & Cosmetic Act?
To get some answer to this, we would have to look to the definition of “labeling.” “Labeling” under FDA law includes any labels accompanying the product, including Internet marketing. So we’ve got labeling.
But a key issue here is going to be whether the way the telemedicine platform advertises and markets the products is truthful and consistent with approved labeling or not.
Certainly, the telemedicine platform should be especially careful when it comes to marketing a substance where the FDA in its pronouncements appears to be dubious or skeptical of the drug’s efficacy or where the FDA emphasizes risks.
Contravening FDA expressions of concern not only risks FDA action and alienation, but also action by its very hungry gobbling twin, the Federal Trade Commission or FTC. FTC goes after companies for advertising that FTC finds false and misleading.
One practical tip here is, the more aggressive the marketing, the more likely to invoke FTC scrutiny. And the more conservative the marketing, the less likely the regulatory flack but obviously the less marketing punch and panache.
If you’re interested in an early read on your healthcare business model, we usually offer a starting Legal Strategy Session with a member of our Legal Team as the very first step.
Thanks for watching. If you have questions, click on the link below, cohenhealthcarelaw.com/contact, to send us a message or book an appointment. As always, we’re here to help and we look forward to talking with you soon.
I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable.
Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes.