David's New Book

Thursday, April 19, 2012

Limited Population Antibacterial Drug Approval (LPAD)

I am posting this very brief blog today to encourage you to support congressional approval of LPAD. The legislation calls for extended authority for the FDA to approve antibiotics based on a limited data set for use in populations with high medical need.  This has been reviewed briefly in a couple of previous blogs. Although I remain unconvinced that the FDA actually needs this legislation from a purely statutory point of view, I have become convinced that they need it to provide cover from congressional criticism when, after approval of a drug based on limited data the inevitable problem emerges. This means that without such cover, it is not clear that the FDA will have what it takes to do the right thing and go forward anyway.  I am also completely convinced that for some new drugs, like  those active only against Pseudomonas or those active against metallo-beta-lactamase bearing organisms like NDM-1, such a new development pathway is absolutely essential.  Luckily - the back-up plan is to seek approval under the auspices of Europe if we cannot under the FDA. Of course, if this occurs it will mean that Americans will be left without access to these new and needed antibiotics.

So check out the summary of the legislation as proposed by IDSA, then write your senator and congressman - please!