The Risks of Relying on Generic Legal Information in Healthcare: Why an FDA Attorney Is Essential

The Risks of Relying on Generic Legal Information in Healthcare: Why an FDA Attorney Is Essential

https://www.youtube.com/watch?v=lBP6l5NELsg

Hi, I’m Michael H. Cohen. I’m founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness.

In today’s video, we’ll talk about the risks of relying on generic legal information in healthcare. Why an FDA or healthcare attorney for that matter is essential.

So, what do you mean by generic? Generic meaning you can use a search, you can use a prompt, and you just get an answer. Why is that just not going to be enough? What is the meaning of life? I guess there are a lot of answers to that, but I’m still searching and, sorry, I’m just not satisfied by what’s on the web, but that’s because the question is really much broader than some generic, generalized answer.

You have to find an answer that’s really built for you that addresses your case, your situation, your matter, your business. And already today a lot of companies are getting in trouble. Because they’re using, for example, generic advertising, generic marketing. So, for example, a clinic offering alternative therapies was using these broad claims that they got online, but those ads didn’t meet FTC and FDA standards, and when these agencies looked at them, they got fined.

So those standards are a matter of interpretation and they’re not just about the rules. If they’d had every single claim reviewed, they would’ve gotten the benefit, not only of avoiding getting hauled up on a sling by the regulators, but also they would’ve been able to titrate their claim so that they were just right.

They have to be assertive and proactive and aggressive enough for the market, but they can’t cross the line. So, for example, you can’t make a disease claim for a dietary supplement. And that’s the kind of thing that you learn by just representing a lot of companies, helping people to craft the language.

It’s very much of a human skill, at least now. And it’s not just experience, but also the case of judgment. Product labels are easy. That’s one that we can riff off of because with supplements, the labeling is not just the label, it’s actually everything that you say about the product.

So, what I found when people present their, like their claims to me, they say, oh, we just have this claim. It’s something on the label, like supports brain health or good for overall mood. But then when you look at their website there are like 50 claims, and you look at their brochure and there’s 20 more, and it goes on and on.

So, it’s about being comprehensive, it’s about being inclusive, it’s about using really good judgment. It’s about having experience to look in the pockets that machines might not look and that generic summaries are not going to give you. It’s the same with telehealth. Same with lots of areas of healthcare law.

So, you know, for a while it’s going to take some human intervention and that’s the expertise that we’re here to deliver.

If you’d like to dive deeper into any of the topics we’ve talked about today, reach out to us. Click below. We’d love to talk to you. We look forward to it.

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