Thursday, July 18, 2013

Antibiotics and Politics

I was intrigued by a recent piece in Genetic and Engineering News on the political scene around antibiotics and antibiotic resistance.  One focus of the article was on the STAAR (Strategies to Address Antibiotic Resistance) act currently wending its way through congress. There is much to like about this effort.  It provides for a sort of advisory (not really oversight) board of experts (specifics to be determined) to coordinate efforts across all of HHS including NIH, CDC and FDA. Of course, its not like this has not been tried before – e.g. the Antimicrobial Resistance Task Force involving the same three agencies.  That task force was limited by funding and turf battles.  How the same sort of boondoggle will be avoid in the pending legislation I don’t know. Another bit would be to add IDSA’s LPAD (proposal for the FDA on Limited Population Antibiotic Development from the Infectious Diseases Society of America) to STAAR. As I say, as a concept there is much to like here.  But as soon as you get into the details, it’s a morass.

First, the statutory requirement  for LPAD legislation is not at all clear to me.  Second, since the FDA has issued guidance on what is essentially and LPAD pathway, one might question the relevance of the legislation. Also – without clear leadership and a hard line manager at HHS, I don’t see the coordinating aspect of STAAR coming together to say nothing of the need for actual dollars to back the new efforts. So I’m skeptical.  I hope that someone from, say IDSA, can set me straight.

Beyond the politics, this entire effort misses the point.  I hate to point this out – but where have the dollars for surveillance for resistance been coming from for the last two decades?  In large part this is being funded by industry.  Of course, as industry drops out of antibiotic R&D and as their products become generic – these dollars will dry faster than mud in a drought. For surveillance and for the new products that we need to deal with resistant organisms we need MONEY!!!!  Unfortunately, these dollars will have to come from pricing for the new products we so desperately need.  This price increase will also probably have to be global to one extent or another.  Europe – I’m speaking to you!!  Yes, UK France, Germany – regulatory reform won’t be enough – new antibiotics to replace colistin might actually cost you silver. And who knows about pricing in China?  Are there any experts out there willing to share their knowledge.  How about India?

Clearly the time for value-based pricing has arrived.  We are already providing funding (mainly through BARDA) for antibiotic R&D in addition to making trials smaller, faster and less costly through regulatory reform. The last step in the pathway is pricing. Rather than spending effort on STAAR – maybe we should focus on the one thing that will make the most difference – MONEY and VALUE-BASED PRICING!

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