Antibiotics: Some Welcome Movement at the FDA

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Dr. David Shlaes, American Council advisor and infectious disease expert, has been blogging about antibiotics since 2009. His website Antibiotics — The Perfect Storm, can fairly be described as a chronicle of massive frustration, interrupted occasionally by good news.

Dr. Shlaes, who was a practicing clinician and researcher, understands as well as anyone the big picture of the bacterial resistance mess that we now find ourselves in.

But, his latest entry is rather encouraging. And also a bit disturbing.

It concerns the "Promise for Antibiotics and Therapeutics for Health Act,” better known as the PATH Act, which was designed, "to create a limited population pathway for approval of certain antibacterial drugs." In other words, facilitating the development of new antibiotics by permitting shorter, more infection-specific clinical trials that involve fewer patients.

Shlaes writes, "Fast forward to 2016. The FDA rebooted its antibiotic development program in 2012 and since then we have seen a flurry of antibiotic approvals including two new antibiotics for the treatment of serious Gram-negative infections. One of these, ceftazidime-avibactam (near and dear to me), was approved mainly based on phase II data."

But, of course, politics is never far away: "I now find that the designs embodied in [the FDA reboot] guidance document that would allow these streamlined approaches are threatened once again by Public Citizen and its congressional meddlers."

He also adds, "The PATH act is currently in mark-up in the senate. It is sponsored by Orin Hatch of unregulated supplements fame (probably not a good thing)."

This would be the same Orin Hatch who we have been criticizing for years for his DSHEA act of 1994, which set up the launching pad that allowed the unregulated dietary supplements industry to take off like a Saturn rocket.

You can read Dave's entire post here.