FDA unveils new plan to kickstart drug development for resistant bacteria

Sept. 17, 2018

The FDA announced a 5-year plan to promote the development of new antimicrobials for drug-resistant bacteria. The plan includes changes to the reimbursement system, which may make drugs more profitable for developers, as well as some nontraditional treatment approaches.

“We cannot count on outracing drug resistance, but we can use stewardship and science to slow its pace and reduce its impact on human and animal health,” FDA Commissioner Scott Gottlieb, MD, said in a press conference. “To do so, we need an all-hands-on-deck approach to combating antimicrobial resistance in both human and veterinary settings.”

According to the commissioner, a robust market and pipeline for antimicrobials do not currently exist. Most large pharmaceutical companies have exited from antibiotic research, he said, leaving only small start-up companies that are not in a position to fund the clinical trials necessary to get regulatory approval. He suggested that more significant “pull” incentives are needed to address this issue.

One such incentive the FDA proposed was reimbursement reform, which could mean a larger financial return for manufacturers. He said that a subscription-based model would allow institutions to pay one rate for a specified number of doses of new antimicrobials. This plan may also include “new technology add-on payments” for certain drugs that are needed for critical patient and public health needs.

In recent years, health officials have put great emphasis on the judicious use of antibiotics to control antimicrobial resistance.

Furthermore, the FDA plans to support the development of biological products that may assist in targeting drug-resistant bacteria, including vaccines, bacteriophages, live biotherapeutic products, and fecal microbiota transplantation.

Gottlieb said that a draft strategy will likely be available for industry by the end of the 2020 fiscal year.

Healio has the full article

Sponsored Recommendations

Enhancing Remote Radiology: How Zero Trust Access Revolutionizes Healthcare Connectivity

This content details how a cloud-enabled zero trust architecture ensures high performance, compliance, and scalability, overcoming the limitations of traditional VPN solutions...

Spotlight on Artificial Intelligence

Unlock the potential of AI in our latest series. Discover how AI is revolutionizing clinical decision support, improving workflow efficiency, and transforming medical documentation...

Beyond the VPN: Zero Trust Access for a Healthcare Hybrid Work Environment

This whitepaper explores how a cloud-enabled zero trust architecture ensures secure, least privileged access to applications, meeting regulatory requirements and enhancing user...

Enhancing Remote Radiology: How Zero Trust Access Revolutionizes Healthcare Connectivity

This content details how a cloud-enabled zero trust architecture ensures high performance, compliance, and scalability, overcoming the limitations of traditional VPN solutions...