FDA News

FDA unveils new plan to kickstart drug development for resistant bacteria

Scott Gottlieb, MD
Scott Gottlieb

The FDA announced today 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 today 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.

“When it comes to developing a medicine to treat multidrug-resistant microbes, the goal is to hold such a drug in reserve and try not to use it,” Gottlieb said. “In other words, the reimbursement scheme is in direct conflict to our public health goals.”

Ed Cox
Edward Cox

The commissioner revealed additional plans to combat antimicrobial-resistant bacteria through stewardship efforts in both veterinary and human medicine by changing labels and treatment duration limits, expanding sampling through the National Antimicrobial Resistance Monitoring System, developing new diagnostic tools to detect resistant pathogens and collaborating with the private sector to guide and receive feedback on a streamlined development process.

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.

“No one person or group can solve this problem. Everybody has to work together,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products at the Center for Drug Evaluation and Research, said in a panel following the statement. “We need the input from all the different groups that are involved in this space.” – by Katherine Bortz

Disclosures: Cox and Gottlieb report no relevant financial disclosures.

Scott Gottlieb, MD
Scott Gottlieb

The FDA announced today 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 today 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.

“When it comes to developing a medicine to treat multidrug-resistant microbes, the goal is to hold such a drug in reserve and try not to use it,” Gottlieb said. “In other words, the reimbursement scheme is in direct conflict to our public health goals.”

Ed Cox
Edward Cox

The commissioner revealed additional plans to combat antimicrobial-resistant bacteria through stewardship efforts in both veterinary and human medicine by changing labels and treatment duration limits, expanding sampling through the National Antimicrobial Resistance Monitoring System, developing new diagnostic tools to detect resistant pathogens and collaborating with the private sector to guide and receive feedback on a streamlined development process.

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.

“No one person or group can solve this problem. Everybody has to work together,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products at the Center for Drug Evaluation and Research, said in a panel following the statement. “We need the input from all the different groups that are involved in this space.” – by Katherine Bortz

Disclosures: Cox and Gottlieb report no relevant financial disclosures.

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