Late Thursday, a group of bipartisan members in the House of Representatives introduced the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013 that would enable the FDA to approve antibiotic drugs for specific patient populations based on data from smaller clinical trials.
According to RAPS, the legislation would modify Section 505 of the Federal Food, Drug and Cosmetic Act to create a new "limited population" pathway for certain antibacterial and antifungal drugs intended to treat serious or life-threatening diseases or conditions. The bill also contains significant provisions tasking the CDC with monitoring the use of antibacterial and antifungal drugs and resistance to those drugs.
Pharmaceutical trade group PhRMA has officially submitted its comments regarding the new legislation, most notably questioning the guidance's heavy reliance on demonstration of superiority (as opposed to non-inferiority) in clinical trials as the basis for approval. (In layman's terms, a superiority trial is designed to detect differences between two drugs and establish which is stronger, safer, more efficacious, etc, whereas a non-inferiority trial is designed to prove that a new therapy is not unacceptably worse than the current standard of care for a given indication.)
The trade group has concerns that in its focus on superiority, the FDA might be overlooking a possible path to developing antibacterials that could prove life-saving for patients in high-need cases. For example, because of the likelihood that microbes can become resistant to the alternate treatment, a drug that is non-inferior to another would be exceptionally useful. "Dependence on superiority alone will thus not create a robust approach to development of the urgently needed diverse, vibrant pipeline of novel antibiotics," PhRMA noted.
