David's New Book

Friday, September 19, 2014

PCAST and Antibiotics - Show me the Money!



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 AntibioticResistant Bacteria (TFCARB) cochaired 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 AntibioticResistant Bacteria composed of nonFederal 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.