Thursday, March 3, 2011

Antibiotics and FDA - Industry must take the lead.

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After my conversation with Brad Spellberg as noted in the previous blog, I have come to the conclusion that the ways forward for dealing with the crisis at FDA are limited.  The guidance documents we are discussing are clearly delineated by Brad in the last blog.

The FDA clearly believes that they are on the right path and that, through the process occurring with the Foundation for NIH Consortium on Biomarkers, they will achieve consensus.  They clearly dismiss my own opinions, and apparently those of several members of the Infectious Diseases Society of America (IDSA) Task Force on Antimicrobial Availability as being misguided or just plain wrong.  This mindset blinds the FDA to the critiques contained in the various industry responses to guidance document dockets.  They seem to believe that the gaps are bridgeable within the context of the released guidance.

One approach for us all is to simply await the results of all the deliberations and hope that we eventually end up with feasible and clinically relevant designs for carrying out pivotal trials of antibiotics.  If such designs are not forthcoming, and if sponsors are either unable to negotiate feasible designs with the FDA or, in a worst scenario, negotiate a design but fail to  to carry out the trial in spite of great expense, where will we be? 

How long is that wait?  Will industry wait?  Will biotech in particular even be able to wait? I think the wait is approximately at least another year – perhaps two or three years.  In that time, I predict that at least one more company currently active in antibiotic R & D will drop out.  I predict that the climate for funding for biotechs and their ability to bring products forward through partnering with larger companies will continue to diminish.

Therefore, the way forward is not to wait.  Industry must be honest and clear with the FDA.  In addition to including in their response to FDA guidance critiques and suggestions on how to change the guidance, they must state that they cannot and will not undertake the trials currently called for in the guidance document in question.  Only this message will draw a clear line in the sand for the agency. 

I understand the reluctance of industry, especially large and mid-sized pharmaceutical companies to take such a stance.  They may be currently trying to negotiate trial designs with the agency either in anti-infectives or in other therapeutic areas and they may be concerned about negative repercussions. Their departments of regulatory affairs are not used to such direct confrontations with the agency (in general).  Nevertheless, for companies still truly committed to the discovery and development of antibiotics, I think that waiting is not an option and that there is little left to lose. 

One way for industry to take this on if they do not feel that they can act individually as a company is to use their trade group, PhRMA to both lobby congress and the administration, and to deal with the FDA. 

So, other than continuing to try and keep this issue up front both for those of you who read this blog and for the world at large, I am running out of things that I myself can do.  I have the impression that IDSA finds itself in a similar position. Industry must help.
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