Does an FDA study approval (an Investigational New Drug Study) mean that a company can sell this drug to the public?
NO, not even close.
Several people have messaged me about exosomes (again) because there are apparently still companies marketing these unproven product and unapproved products to the general public!
Hypothetically speaking, If a USA company had a FDA approved IND to study exosomes for a kidney or heart or pulmonary condition (like post COVID)....can they now resume selling exosomes for general use?
I mean we are still nowhere near FDA approval of exosomes even for the condition for which the IND was granted. The answer in my opinion is clearly no. (DYOR..ask your own attorney).
The process from IND to drug approval is not guaranteed...it takes a successful study showing that the drug does in fact work and is safe for the proposed indication.
Exosomes still cannot be sold and used in humans in the USA for any indication because they are drugs (per FDA) and have no FDA approval. The approved IND does not change that. There are still some big big hurdles.
Anyone selling or using exosomes in humans in the USA right now needs to close their barn door or be on the lookout for the next FDA Warning Letter.
The alternative? We continue to use Platelet Rich Plasma and other regenerative medicine techniques that are in fact FDA compliant! We won't inject our patients with unapproved and unproven drugs!
Common questions
- Are exosomes FDA approved for anything?
- No, not for any indication in the United States. The FDA considers exosomes to be drugs, and no exosome product holds FDA approval. Any company selling or using exosomes in humans in the USA is operating outside that framework and should expect to be on the receiving end of the next FDA Warning Letter.
- A company says they have FDA approval for an exosome study. Does that make it legal to sell?
- No. An approved Investigational New Drug application is permission to study a drug, not permission to sell it. Even a company holding an IND to study exosomes for a kidney, heart or pulmonary condition is nowhere near approval for that condition, let alone for general use. Going from IND to approval requires a successful study showing the drug works and is safe.
- What do you use instead of exosomes?
- Platelet-rich plasma and other regenerative medicine techniques that are FDA compliant. PRP is made from the patient's own blood during the visit, which places it outside the drug framework that makes exosomes unlawful to sell. Texas Orthobiologics does not inject patients with unapproved and unproven drugs, whatever the marketing around them claims.
