Friday, July 10, 2020

AMR Action Fund - a Bridge - to Where?

Yesterday, I listened to the global launch of the AMR Action Fund. The fund and its launch are also described in an article in the NY Times by Andrew Jacobs. Better yet – you can watch the launch here. In a way, this is a miraculous development that came to be under the leadership of Peter Beyer at the WHO. John Rex said he had tears in his eyes watching the launch. 

The AMR Action Fund, with pledges of $1 billion, was created by leading pharmaceutical companies and supported by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Investors include large companies like Merck who still carry out antibiotic R&D efforts and those like Eli Lilly which was one of the first to abandon the area around 20 years ago. These investors recognize the constant and growing threat of antimicrobial resistance.  They are cognizant of the lack of investment in the space that is leading to an inability to bring important new therapies to market and to threaten the very existence of those companies who attempt to do so. Their intent is to provide a bridge by funding the expensive phase 2 and 3 clinical trials and attendant development costs required to achieve regulatory success and market entry. Their goal is to bring 2-4 new, high priority antibiotics to patients by 2030. No wonder John Rex was moved to tears.

 But the AMR Action Fund investors also recognize that without government action, probably on a global scale, to put in place significant pull incentives their funding will be a bridge to nowhere. And this is where my own tears of sadness and despair come in. Much of the discussion focused on the DISARM act here in the US that would provide hospitals an add-on reimbursement for high-priced new antibiotics. But as I’ve stated many times in the past, this may only be a first, sort of baby step. Senator Casey, in his remarks, spoke of the GAIN act.  The regulatory components of that legislation were welcome – especially the requirements for feasible trial designs and for streamlined development and review for priority antibiotics.  The financial incentive – five years of additional exclusivity - was never an incentive for the vast majority of products with patent lives beyond a few years after approval. The DISARM act is restricted to those patients who actually need therapy in the hospital and may not, therefore, provide for the kind of fire extinguisher approach that we need.  (We pay for firepersons and extinguishers in the hope that we never need them). In fact, the presenter from Pfizer mentioned incentives such as subscriptions and transferable exclusivity vouchers. I agree with those choices in addition to a simple market entry reward contract. 

Without government action, we all understand that the AMR Action Fund, as inspiring and generous as it is, will be a bridge to nowhere. We all need to work harder to reach out to other stakeholders and bring them in to our cause before its too late. 

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