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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