Bacterial and fungal infections that follow on the back of SARS-CoV-2 coronavirus have forced doctors to increase the use of antibiotics and antifungal medications, but our supply of viable medications is diminishing because of antimicrobial resistance (AMR).
More than 2.8 million drug-resistant infections occur in the United States each year, killing more than 35,000 people, according to the Centers for Disease Control and Prevention (CDC).
New drugs are desperately needed to fight these infections, but unfortunately the market does not support development of such drugs.
“Treatments for resistant infections are extremely difficult to develop, and opportunities to recoup development costs and to make a return on investment are limited. Currently, it takes 23 years for a company to see profit on a new antibiotic,” according to the Partnership to Fight Infectious Disease (PFID). “Without effective antimicrobial medicines, patients lose not just treatments for serious infections, but they also face significantly increased risks from many medical services that rely upon the effective prevention and treatment of infections.”
PFID—a group of patients, providers, community organizations, academic researchers, business and labor groups, and infectious disease experts—advocates for policy reforms that will help activate and support research and development of novel antimicrobial medicines to treat drug-resistant illnesses. To raise awareness, PFID declared March 18 the Squash Superbugs Day of Action, calling on policymakers to act now and help prevent the threat imposed by this crisis.
BIO’s report: ‘Market dynamics do not exist’
“The primary issue forcing big pharma out of the antibacterial sector and leaving small company innovators empty handed is that the traditional market dynamics do not exist for antimicrobials,” according to a report published in February by Biotechnology Innovation Organization (BIO).
The BIO research examines the limited pipeline for novel antibacterial drugs, the market’s particular investment hurdles, and potential legislative measures to help new therapies emerge.
One of the report’s key findings is that, while there have been 164 FDA-approved direct-acting antibacterial new chemical entities (NCEs) since the early 1900s, only one new molecular target NCE has been approved in the last 35 years, demonstrating the need to broaden the antibacterial discovery engine.
The report suggests several potential solutions to strengthen the antibacterial pipeline: 1) early-stage investment (push mechanisms for research); 2) regulatory incentives; 3) late-stage investment (push mechanisms for development); 4) market-based mechanisms (pull incentives); and 5) reimbursement reform.
Legislation seeking change
Reimbursement reform is the goal behind proposed federal legislation The Pioneering Antimicrobial Subscriptions to End Up Surging Resistance (PASTEUR) Act was reintroduced in the U.S. Senate in 2021 to spur innovative drug development targeting the most dangerous infections, as well as to improve the appropriate use of antibiotics and ensure domestic availability of the drugs when needed.
The PASTEUR Act, a bipartisan bill cosponsored by Senators Michael Bennet (D-Colo.) and Todd Young (R-Ind.) and Representatives Mike Doyle (D-Pa.) and Drew Ferguson (R-Ga.), authorizes the federal government to provide market incentives for discovery of lifesaving antimicrobial medications.
Developers would be paid contractually agreed-upon sums on an annual basis for a period ranging from five years to the life of the antimicrobial’s patent. The clinical necessity and originality of the medicine would determine the eligibility and value of the subscription contract.