Matt Metz and I have just
published an article
in Antimicrobial Agents and Chemotherapy that I wanted to highlight for you
here. We provided eight strategies in
addition to those previously proposed by Bartlett et. al. Our list is a little more unexpected and
subtle than the more obvious strategies you may have seen elsewhere, which is
why I think its worth highlighting our list here. For details, please see the link to the article
above.
1. Reduce Clinical Trial Risk and Uncertainty.
Basically, we ask the FDA to make their data on previous antibiotic trials
available such that external, historical controls can be constructed using
pharmacometrics. This would allow for
the feasible conduct of rapid superiority trials for new antibiotics targeting
resistance.
2. Boost Market Value for Not Feeding Animals
Antibiotics. Here we ask the USDA to develop a label certifying that growth-promoting
antibiotics have not been used for the product so labeled.
3. Strengthen Regulation of Farm-Feeding
Antibiotics. Here we suggest that
the EPA require manufacturers of antibiotics for agricultural use to generate
data on the environmental and public health consequences of such use. The EPA would then set standards under which
such use would be allowed (or not). They
already do this for fungicides, insecticides and rodenticides – why not for
“bactericides”?
4. Unify US Government Efforts. We are just asking that the federal government
do a better job of coordinating efforts of all its agencies in this regard and
that this coordination be given enough teeth for enforcement that the agencies
will be incentivized to actually work together on this as opposed to being in
constant competition.
5. Incentivize Early Sharing of Data. Although
much is now published early online – there are still delays for reviews and
revisions. While these lead to higher
quality publications, sometimes these delays may be deleterious to the public
health. We just ask that journal Editors
be aware of when something like NDM-1 is being reported for the first time that
speed of public notification might be more important than worries about prior
publications and other editorial concerns.
6. Assure the Quality of Generic Antibiotics. We
just ask that the FDA be a little more strict in its requirements for generic
manufacturers of antibiotics. In this
case, the generic must achieve a level of pharmacokinetic equivalence within a
90% confidence interval compared to the branded product. Given the complexities
of the pharmacodynamic relationship between activity of the antibiotic against
bacteria in vitro and its presence in human tissues in vivo, maybe we should be
more demanding here.
7. Level the Playing Field between New and Old
Antibiotics. Here was ask that the FDA continue along its current trend of
re-evaluating generic antibiotics to make sure that they will meet today’s FDA
standards for branded products. That is
frequently not the case – especially as far as determining breakpoints is
concerned. Re-review of breakpoints for generics is a key activity for the FDA
in our view.
8. Assure value-based pricing of new
antibiotics. You’ve heard this one from me before.
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