Well boys and
girls, ladies and gentlemen, the long-awaited PCAST (President’s Council of
Advisors on Science and Technology) report
on antibiotic resistance has been
released. The report is much better than
I expected in some areas and disappointing in others.
Highlights of the
report are –
·
The
President should task the National Security Council, in coordination with the
Office of Science and Technology Policy and the Office of Management and Budget
(OMB), with oversight and coordination of Federal efforts to combat antibiotic
resistance, and appoint a member of the National Security Council staff as
White House Director for National Antibiotic Resistance Policy (DNARP),
supported by adequate professional staff, devoted fully to ensuring integration
and accountability and annual reporting. The President should also establish an
interagency Task Force on Combating Antibiotic‐Resistant
Bacteria (TF‐CARB)
co‐chaired by the Secretaries of
Agriculture, Defense, and Health and Human Services or their designated
deputies and having members from all relevant agencies and establish a
President’s Advisory Council on Combating Antibiotic‐Resistant
Bacteria composed of non‐Federal
experts.
o
Although this kicks the current Interagency Task
Force on Antimicrobial Resistance to a much higher level – I remain skeptical
given the difficulty for all these agencies to speak to each other much less
actually work together. The fact that
they all compete with each other for funding doesn’t help.
·
Strengthen State and local public health
infrastructure for surveillance and response. ($90 million per year).
·
Establish a national capability for
pathogen surveillance based on genome analysis. A multiagency effort that will
require $190 million per year.
·
Expand fundamental research relevant to
developing new antibiotics and alternatives for treating bacterial infections (NIH,
FDA, DARPA, DITRA).
·
Develop alternatives to antibiotics in
agriculture. (USDA, NIH - $25 million per year to fund an Innovation Institute
at USDA).
·
Establish a robust national
infrastructure to support clinical trials with new antibiotics (NIH, FDA - $25
million).
o The NIH is already doing this. It involves developing a network of hospitals
to serve as centers for clinical trial research on new drugs and other
approaches to antibiotic-resistant infections.
·
Develop new regulatory pathways to
evaluate urgently needed antibiotics.
o Here PCAST notes that in spite of the
FDA’s call for new legislation to support this effort, the FDA already has
sufficient statutory authority to carry out this task without congressional
action. This is something I have been saying
for the last several years as well. In
fact, the FDA has already started down this path anyway.
· The Federal Government
should significantly increase economic incentives for developing urgently
needed antibiotics.
o Here
PCAST again agrees with my view and that of many experts that the GAIN Act was
entirely insufficient to provide the kind of return on investment that
pharmaceutical companies require to invest in antibiotic R&D.
o PCAST
recommends that BARDA’s brief be expanded beyond bioterror threats to the
overall threat of antibiotic resistance.
They recommend and additional $400 million per year in funding for BARDA
to fund antibiotic R&D.
o They recommend support for the higher prices that these new antibiotics will command
by authorizing CMS (Center for Medicare/Medicaid Services) to provide
reimbursement to hospitals when required. Other insurers usually follow CMS.
o PCAST
supports a delinkage approach where government provides a guaranteed purchase
of product upfront upon approval. This could either be a complete buyout of
around $1 billion or a smaller amount that would then serve to decrease the
price of therapy. They recommend that
BARDA be given this responsibility with an additional $400 million annually.
§
Sound familiar?
See my previous blogs on antibiotic pricing.
o Tradable
vouchers – this is PCAST lingo for wild card patent exclusivity – something I
suggested in the context of the IDSA report Bad Bugs No Drugs back in
2004. Still a good idea that is sure to
be rejected by all.
o Antibiotic
usage fee – by adding a fee to the price of antibiotics already approved some
of the above might be funded. Good luck
on that one.
·
Improve Antibiotic Stewardship – expand to
settings like long term care and outpatient care.
·
Establish a prize for breakthrough point of care
diagnostics.
o Great
idea.
·
PCAST calls for more research on whether the use
of antibiotics in animals contributes to the resistance threat to humans.
o Are
you kidding me? To me, and I’ve only been working in the area for around 30
years, the answer is already established.
Even if one has doubts, the benefits to producers cannot possibly be
outweighed by the more cautious approach of restricting antibiotic use in
agriculture. This is a great
disappointment in the report.
o By
the way – the FDA has already responded
to the PCAST report emphasizing their voluntary approach to restricting antibiotic
use in agriculture.
·
PCAST calls for international cooperation.
o Yes. Good luck on this one. Are you listening FDA? Harmonize with Europe?
President Obama has already issued a set of executive
orders aimed at implementing the recommendations of PCAST. There is just
one thing missing here. PCAST has
recommended spending several billions of dollars. Where is the money? Show me the money! Without congress – and we
are definitely without congress – much of this is arm waving. To me – that is the most disappointing aspect
of this well conceived (mostly) report.
No comments:
Post a Comment