(Continued) FDA Plays Chicken With Antibiotics: Newly Exposed Documents Reveal Agency's "High Risk" Gamble With Human Health

Carmen Cordova | Switchboard | January 27, 2014

Just to offer a little more insight on FDA’s inaction, discussed broadly in a previous blog, I’ve detailed the history of just one of the antibiotic additives in question here.

Penicillin G Procaine 50/Penicillin 100 (NADA:046-666) is an antibiotic feed additive and as good an example as any of FDA’s failure to protect public health (see the report for references). The drug is approved for use for growth promotion and increased feed efficiency in pigs, chickens, and turkey and continues to be marketed in spite of risks to human health. Here are the details:

In the early 1970s, the drugmaker (“sponsor”) submitted an application for an antibiotic additive containing Penicillin G procaine and also submitted plans for scientific studies to show antimicrobial safety, to respond to safety regulations put in place by FDA in 1973. In their review, FDA scientists noted not only that the studies that were eventually submitted and linked to the application had flaws -- meaning that they were poor evidence for the additive’s safety -- but also that some of the studies actually  showed evidence of increased antimicrobial resistance to other antibiotics from the use of this additive. [...]