A system that provides both safety and accessibility.

4 days ago
16

Where the FDA’s coming from: To be fair, the FDA isn’t wrong here. The supplement and compounded drug industries do need oversight. There’s been contamination, inconsistent dosing, and products that never should’ve made it to patients. The agency’s goal (ensuring safety and consistency) is absolutely valid.

But the way they’re going about it? That’s the problem. Originally, manufacturers had until 2029 to comply with the new biologics classification. That timeline made sense; it gave small producers time to build the infrastructure, gather data, and secure the funding. Then suddenly, the deadline was cut to 2025. That’s four years wiped away overnight making it an impossible ask for companies already stretched thin.

So while the FDA’s goals make sense on paper, the real-world impact hits patients hardest. Smaller manufacturers can’t meet the deadline, meaning supply shortages, price hikes, and fewer options for those who depend on NDT. Safety matters, but so does accessibility.

It’s not about choosing between safety and access. It’s about creating a system where we don’t have to sacrifice one for the other.
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