Thursday, February 10, 2011

Anybody Home?

I just returned from the International Conference on Drug Development held in Austin, Texas.  All the big FDA brass were there including Janet Woodcock, Bob Temple, Bob O’Neill and others.  Ed Cox was on the schedule, but he hurt his back (I hope you’re feeling better, Ed) so his deputy, John Farley came instead.  Poor John had to endure my tirades.  At least he reads my blog so he knew what to expect. NO ONE from FDA top management stayed around to hear the antibiotics section of the meeting.  They abandoned John to the wolves (myself and Barry Eisenstein of Cubist).  Bob Temple had already departed.  I heard that Janet Woocock was in her room working.  Now, it’s true that the antibiotics section occurred as the last set of meetings for the three-day conference.  Nevertheless, I think the FDA attendance tells us something about the priority they give both to antibiotics and to those of us who disagree with their current approach to antibiotics. I wanted to cry!

John Farley mentioned that the only comments to the docket on the recent guidance on nosocomial pneumonia came from me!  Where are all of you????

My talk was entitled, The FDA and Antibiotics – the Road to Global Irrelevance. The argument I tried to make was that the US share of the world pharmaceutical market and of the world antibiotic market in particular is shrinking.  The growth of the US market is shriveling compared to other world markets.  (I received a download of IMS data from my good friends at Astra-Zeneca to whom I am very grateful).  You can find all my slides at my website or just follow this link.  The US now accounts for only about 25% of the world antibiotic market compared to 35-40% 5 years ago and up to 50% a decade or more ago.  While the US is still a large market, it has recently been surpassed by the Asia-Pacific countries.  Those markets are expected to continue to grow at a rapid pace while US growth is expected to be relatively flat.  So, for small companies who can make it through the expensive Phase III trials, I argued that it would make sense for them to register their products in Europe and use the EU approval to drive approvals in Asia-Pacific and other emerging markets as well as Europe. I’m not sure this will work at the current time for large pharma – but it may well be a viable approach in 5 or 10 years.  Then again, with our current situation, I don’t expect to have any big pharma companies still pursuing antibiotic R&D after 5 or 10 more years. 

I also argued that there would be three conclusions to the current FDA pathway.  1.  Companies will abandon the field entirely or the US entirely.  2.  Companies will register their antibiotics in the US where trials are feasible (ABSSSI), for other indications in the rest of the world and count on some US off label use for increased returns.  3. The current FDA anti-infectives group will eventually go away since they won't have any work.  4.  All of the above.  In any case, off label use of approved antibiotics will increase in the US since physicians understand where and how they will work better than the FDA in most cases.  None of these outcomes are desirable by anyone.

Finally, I suggested a new path forward.  Push the reset button.  Start over.  Scrap all the recent guidance documents.  Convene a task force or committee (I can’t believe I’m saying this.  I hate committees and task forces!)  to provide totally new trial designs not to the FDA but to the Secretary of HHS.  This committee cannot include any of the current players.  The FNIH group would be out.  It would have to include industry.

With the FDA continually releasing guidance requiring infeasible trials, the US will be irrelevant for registering antibiotics in any case.  I am extremely disappointed that the FDA top management didn’t bother to attend that section of the meeting.  The message is quite clear.  We are on our own.  Without congress, the administration, or some influential lobbying group of consumers, we are doomed in the US.  

The EMEA had its Scientific Advisory Group on Anti-infectives this week.  I don’t know what happened.  I know the FDA was there by phone briefly . . .I can only hope that they continue to ignore the recent FDA guidances.

Maybe I’ll be a little less depressed next week . . .

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