The FDA and Antibiotics - the Road to Global Irrelevancy

I am scheduled to present to the International Conference on Drug Development in February. My title is The global threat of infectious diseases and the challenges to develop new drug therapies. But, as you might expect, I will be spending my time speaking about the FDA and antibiotic development.  I think my plan is appropriate since I think that the one most easily reversible cause of the antibiotic pipeline tailspin we find ourselves in is to have the FDA reverse course.  Many of you might think that if that is the most easily reversible cause of our current disaster, then all is lost.  I don’t agree simply because, from a public health perspective, there is no choice.  Further, I can’t contemplate a future as I age, and as many of my friends and loved ones age, where we won’t have the antibiotic therapies we need when we need them.

I have been examining the pharmaceutical marketplace as a starting point.  What I find, compared to what was true back when I was at Wyeth 10 years ago now, is that the US is becoming much less relevant as a pharmaceutical market in global terms.   The US share of the global market for pharmaceuticals has apparently fallen below 40% (figure below).  This is astounding to me since all the years when I was at Wyeth, the US accounted for over 50% of the world pharmaceutical dollar market and about 60% of profits given the higher prices found here.  

If you look at market growth, the US contributes an ever-decreasing share of growth as illustrated by the figure below.

What does this mean for antibiotics?  Well, if the US market share keeps dropping and our growth rate keeps falling, it would make sense to simply market elsewhere in the world and forget trying to comply with impossible FDA standards for approval.  Another strategy would be to launch in the US based on feasible trial designs – right now that would be for skin infections, and then profit from off label use in the US.  At the same time, one could get approved in the rest of the world for all the indications the FDA has now made untenable in the US.   I think this strategy makes the most sense for biotechs that want to or need to go the way of Cubist.  Small companies can wield a hospital sales force in countries outside the US and still make reasonable revenues and profits for their size.  Since many of the new products are now coming from biotech, this could be a viable plan for getting new antibiotics out there – just not for the US, unfortunately.

What this might mean for the US is no access for patients to needed new antibiotics, or access only in an off-label setting.  No one wants this kind of outcome – not the FDA, not physicians and not patients.  To avoid having the US market for antibiotics become completely irrelevant, the FDA has to do something differently.  A great starting point would be feasible ways of registering new antibiotics in the US.