I hope everyone had a happy Easter holiday. Its raining here today, and under these
depressing conditions, I find myself thinking back to the Ketek
scandal of 2006 and wondering about the continued meddling of Congress under
the influence of Public Citizen in antibiotic trial design issues. What am I
talking about? See my book
chapter on the FDA. (I apologize, but they still charge $29 for the chapter
download). Basically, in 2006, after a
few cases of serious liver toxicity caused by Ketek, a new antibiotic active
against resistant bacterial pathogens, the FDA was threatened with congressional
investigations on the antibiotic trial designs that led to the Ketek
approval. The FDA went into defense
mode, people were fired or transferred and antibiotic development went from
slow to non-existent for the next six years.
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 (even though it met a
15% NI margin and top line data from one phase III trial was available). This
was a historic first for the FDA.
In its reboot process, the FDA released a guidance
for the development of antibiotics for patients with unmet medical needs. This
guidance calls for streamlined trial designs to get needed antibiotics to the
patients who need them quickly. It was under this guidance that ceftazidime-avibactam
was approved based on a smaller data set than any other antibiotic in modern
times. I now find that the designs
embodied in this guidance document that would allow these streamlined
approaches are threatened once again by Public Citizen and its congressional
meddlers. This time, I don’t know who it is in congress that is involved. But
the stream of questions from congresspersons and veiled threats of
congressional investigations harken back to the dark days of the Ketek scandal
and the FDA once again may respond by ducking back into its shell. And when
that happens, you can forget about new trial designs for rare infections,
pathogen specific antibiotics and other needed new approaches to antimicrobial
therapy.
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). There are many moving parts
here including LPAD, ADAPT etc – but PATH has the language I think the FDA
wants and I like it better. It provides congressional authority by law for the
FDA to carry out much of what is already outlined in the FDA’s unmet need
guidance. The FDA believes (in my
opinion) that this will protect them from congressional meddling and threats of
investigation for their decisions regarding antibiotic development and
approval. I am not at all convinced that this is the case. I also believe that the FDA already has the
statutory authority to do what the PATH act outlines. But – the FDA wants this – and – at this
point, if it helps them, it helps us. So – write your congressional
representatives. At the same time, please ask them to leave the FDA alone on
antibiotic development issues and ask them to ask their colleagues to do the
same.
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