David's New Book

Sunday, August 17, 2014

8 More Ways

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.