5 ms·
Seems like a stretch to argue a biological organism qualifies as a drug.
by Sevii 2y ago
Seems like a stretch to argue a biological organism qualifies as a drug.
- SamBam 2y agoExcept 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.
- perlgeek 2y agoLive-attenuated vaccines (see [1]) seem to fit that role, and have been around for ages. I'd be very surprised if they didn't count as drug. [1] https://www.hhs.gov/immunization/basics/types/index.html https://www.hhs.gov/immunization/basics/types/index.html
- dekhn 2y agoIt's not a stretch at all.