A recent article in Politico (blogger won’t let me use links for some reason), suggests that there is a good chance PASTEUR won’t pass this legislative session. I just don’t get it. The US is losing more and more lives to antibiotic-resistant infections. The antibiotic pipeline is a shambles. The few pipeline products that hold the promise of new activity against highly resistant pathogens also hold the very high risk of bankruptcy for their corporate sponsors in the absence of new investment in the antibiotic market. PASTEUR is designed to provide that investment. Apparently, our representatives in congress are worried about spending. The cost of PASTEUR, a subscription payment plan to incentivize antibiotic R&D, was estimated to be $11 billion over 10 years. After negotiations, the cost in the most recent draft of the bill has been reduced to $6 billion by reducing the term of the bill to 5 instead of 10 years (according to John Rex and Kevin Outterson). Other aspects of the bill have remained intact. We are now talking about $6 billion spread across a population of over 330 million souls over a five-year period. Compare that to the US healthcare budget of $3.2 trillion per year. You’ve got to be kidding, right? This does not even amount to a rounding error.
In my view, we are at a do-or-die moment for a number of antibiotic biotechs and for the few investors still supporting antibiotic research and development. No amount of research support from BARDA, AMR Action Fund, CARB-X, or BARDA will make up for the disincentive of the broken and absent antibiotic market. The only hope for us is an intervention like PASTEUR to provide a market for needed new antibiotics. The market intervention envisioned by PASTEUR is a subscription plan where a sponsor that successfully brings a new and needed antibiotic to the marketplace is guaranteed the purchase of a certain number of treatment courses for a prescribed period of time and is based on contractual obligations undertaken by the sponsor. This is well-designed legislation that would be successful if enacted. It has been under consideration in one form or another for about a decade. But I fear that the sands of time will run out this year. This is it. No more chances. Now or never.
The market incentive that may be contemplated by Europe is still a glint in their eye. They are aiming for something in 2024. This will be too late and possibly not big enough depending on what they enact. In the absence of Europe – the US is it. Outside Europe, the US is the only economy large enough to provide an incentive that is sufficient to actually function as an incentive.
Kevin Outterson says he feels better about PASTEUR now than ever. He is definitely closer to this entire process than me. But having worked for the Department of Veterans Affairs as an infectious diseases physician for 16 years, I am a little more cautious in my view. My daughter keeps reminding me of all the positive and important things government can accomplish. My own experience is one of a government that has difficulty tying its own shoelaces. During my 16 years at the VA, I think I can remember three where the budget was passed on time without a continuing resolution and the resulting end of year dysfunction. I am therefore more afraid that PASTEUR will either never see the light of day or will be too little too late. But I am also mindful and hopeful that PASTEUR will be an incredibly important contribution to public health.
So, my message to all who might see this is – make sure your representatives know how strongly you feel about passing PASTEUR in the US and about providing a real incentive in Europe before it’s too late.
