The prospective legislation was drafted close to three years ago and has struggled to get through Congress — but neither legislators nor the industry are ready to give up.
Last week, senators Michael Bennet (D-CO) and Todd Young (R-IN) and representatives Drew Ferguson (R-GA) and Scott Peters (D-CA) reintroduced the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act in Congress. The bipartisan, bicameral legislation was initially introduced in Congress by Bennet and Young in September 2020; the senators reintroduced it to the House and Senate in June 2021.
If finally passed, the law would change the way the U.S. government pays for critically needed antimicrobials, basing it on value to public health, not sales volume.
Under PASTEUR, developers would appeal to a Department of Health and Human Services (HHS) committee to have their drugs designated as ‘critical need antimicrobials’ — a criteria that would be defined within the bill and updated to reflect changing resistant threats.
Developers who qualify would be eligible for contracts ranging from $750 million to $3 billion, over 5-10 years, with the first payment granted upon the drug’s FDA approval. In return, patients covered by federal insurance programs would receive these drugs at no cost.
“The bipartisan PASTEUR Act is the strongest bill ever written to strengthen antibiotic development and use. It will fix our market failures, expand the pipeline for next generation antibiotics, and save lives. We can’t sit on our hands as this public health crisis arrives — we have to act now,” said Bennet
Arguably, the public health crisis has already arrived. Every year, more than 1.2 million people worldwide die from antibiotic-resistant infections, and if no action is taken, it’s estimated this number will grow to 10 million per year by 2050. But despite the collective acknowledgement of the dire need to develop and manufacture new, innovative antibiotics to fight off these so-called ‘superbugs,’ the market dynamics simply aren’t cooperating.
While using antibiotics sparingly and in short duration can help preserve their effectiveness, this also makes it extremely challenging for companies to generate a viable return on investment for the innovations they bring to market. ‘Pull’ mechanisms such as PASTEUR are designed to incentivize private sector engagement by creating market demand, sending signals to industry that a viable commercial market exists.
The PASTEUR Act has earned the support of the broad health care industry, pharma included. Back in March, more than 230 organizations representing healthcare providers, public health professionals, scientists, and the pharmaceutical and diagnostics industries sent a letter to the chairs and ranking members of Congress urging them to back the legislation.
Prominent national organizations — including pharma trade group Biotechnology Innovation Organization (BIO) — issued a statement applauding the recent reintroduction of PASTEUR calling it "a critical step forward to address the antimicrobial resistance crisis that threatens the public health and U.S. national security and preparedness."
Many industry insiders believe that fixing the broken antibiotics market now hinges on policy reform. While bills like PASTEUR would bring tangible relief in the form of financial incentives, the real game-changer lies in the global message the U.S. would send by passing them: The antibiotics market is viable, profitable and no longer ablaze.
