Except it's not at all. The FDA regulates plenty of live organisms as drugs if they're claimed to be used to treat diseases.
For example, fecal transplants are regulated by the FDA. Rebiotix Inc is developing a bacterial fecal transplant, RBX2660, and Seres Therapeutics is developing an oral version (also live bacteria) called SER-109. Both of these are being regulated by the FDA.
There are hundreds of other live biotherapeutic products (LBPs) regulated by the FDA.
Comments
Except it's not at all. The FDA regulates plenty of live organisms as drugs if they're claimed to be used to treat diseases.
For example, fecal transplants are regulated by the FDA. Rebiotix Inc is developing a bacterial fecal transplant, RBX2660, and Seres Therapeutics is developing an oral version (also live bacteria) called SER-109. Both of these are being regulated by the FDA.
There are hundreds of other live biotherapeutic products (LBPs) regulated by the FDA.