After several months of intense study, President Obama released a package of actions today designed to combat antibiotic resistance.
The most surprising action item is the creation of a one-time $20 million prize for a new point-of-care diagnostic for highly resistant infections. That is a big deal, on top of the £10 million UK Longitude prize on the same topic. Hopefully, HHS (NIH & BARDA) will coordinate with the UK on this prize. This is very encouraging news. In the 2014 ERG Report, we found a MRSA rapid point-of-care diagnostic to have a value to society exceeding $22 billion. These prizes are bargains – if they work, we get an exceedingly valuable diagnostic; if they don’t, no federal money is spent.
President Obama issued an Executive Order to direct federal agencies to implement the President’s Council on Science and Technology (PCAST) Report. We will also have a National Strategy with Cabinet level leadership, led by HHS with Defense and Agriculture.
Additional limits are proposed on antibiotic use in agriculture, above and beyond the recent FDA actions, especially for classes useful for humans. This is a “One Health” strategy, using WHO language, a combination of human and animal health, including food safety and the environment. For antibiotics, we are just now understanding the spread of antibiotic resistance genes in the environment and the interaction between animal use and human health is a serious concern. 80% of US antibiotics by weight are used in agriculture.
I was also encouraged by the emphasis on international coordination.
Actual texts will be released in an hour. I’ll update with links.
UPDATE: Executive Order here. The PCAST Report is here. The National Strategy is here.
Key proposals from PCAST today, my comments in bold italics:
- Double federal spending on antibiotic resistance research, surveillance and prevention, an additional $450 million per year. This is a huge increase, exactly what is needed. Will need Congress to appropriate the funds.
- including $90 million in additional CDC grants to strengthen state and local public health surveillance and response to bacterial resistance
- National surveillance based on genomic sequencing ($190 million per year) A good time to be a post-doc in whole genomic sequencing of bacteria
- $150 million over 7 years to basic research to support non-traditional approaches to overcoming antibiotic resistance
- $25 million per year to develop alternatives to antibiotics in agriculture. Give the farmers options – another good idea.
- $25 million to create a national clinical trials infrastructure for antibiotics. Will reduce costs for everyone.
- Replenish BARDA funding for public-private partnerships in antibiotic R&D, with approximately $800 million per year, roughly equal to one new antibiotic per year. This is huge – a stunning announcement and precisely what many have been privately calling for. BARDA has supported many key antibiotics in the pipeline. This announcement is a prominent vote of confidence in BARDA’s model.
- Make antibiotic stewardship a condition of participation in Medicare by 2017 and a condition for receiving federal grants. Hospitals were expecting this.
- $25 million prizes for “rapid, inexpensive, and clinically relevant diagnostics that can substantially improve therapy in important clinical settings.” Joins the UK Longitude Prize and promises to work with prizes from other nations and private foundations. This is a larger prize than reported separately by the White House and contemplates multiple prizes, not just one.
- “PCAST strongly supports FDA’s new Guidances 209 and 213, designed to promote the judicious use of antibiotics in agriculture.” No solid action beyond existing FDA Guidance.
- “Vigorously support” the WHO Global Action Plan Good news, as the WHO Plan will need resources to be effective globally.