David's New Book

Wednesday, December 8, 2010

Antibiotics and the FDA - Where are we?

Janeen Interlandi just published an interesting article in Newsweek where she explores the perfect storm we are facing over the future of antibiotics.  She concludes that we need a new way of thinking about antibiotics, but offers precious little in terms of direction. I guess she is just as confused as the rest of us.

I continue to believe that one way forward will be for the industry and the FDA together to devise FEASIBLE trial designs for antibiotics such that they can be developed and approved in the US.  The other option – I think of it as the nuclear option – is to declare the US antibiotic market irrelevant and inaccessible and to focus on Europe and, more importantly, the emerging markets like Brazil, Russia, China, India, Mexico and Turkey (BRCIMT).

But since the US is still a relevant, even important, market, lets examine what we have left in terms of a path forward for antibiotics and lets contrast that with where we need antibiotics the most.  The table below shows that those indications where the medical need, at least in the US, is the greatest for new antibiotics are either not so attractive markets or, in the case of hospital-acquired pneumonia and ventilator associated pneumonia, are indications where the FDA-required trials are simply infeasible.  The other message from this table is that there are precious few indications left in which new antibiotics will be marketed.

So, the choices we have are:
  1.  A process that allows industry and FDA to actually come together and agree on FEASIBLE trial designs (the FNIH seems to be the same people saying the same things but in private).
  2.  Incentives that will work (but we still need feasible trial designs for indications where there is clear medical need).
  3.  Further loss of pharmaceutical companies from antibiotics research.
  4. The nuclear option.
Under number 1 above, and in line with Ms. Interlandi’s article, I favor a new approach.  Lets take the current FDA team and all its consultants out of the room and replace them with FDA top management and their consultants.  Lets get an entirely different team of statisticians.  Lets get industry and IDSA to present their best and most innovative designs and strategies. Lets lock the room for about 3 months and make them come up with something FEASIBLE for antibiotic development.

If we can’t make this work, we’re left with the nuclear option.  Option 3 will probably occur anyway.

Enhanced by Zemanta