Gottlieb Proposes Payment Incentives to Spur Development of AMR Therapies

The FDA announced a new, 4-pronged approach to the growing problem of antimicrobial resistance (AMR), as it unveiled a 2019 strategic plan that envisions innovative payment strategies in an effort to spur pharmaceutical companies to develop new antibiotics.

According to the CDC, 2 million people develop serious infections caused by bacteria resistant to antibacterial drugs, and at least 23,000 people die. But drug development to create new antibiotics is running thin.

The FDA also introduced a new web page that tracks its work on antimicrobial resistance.

At an appearance at the Pew Charitable Trusts on Friday, FDA Commissioner Scott Gottlieb, MD, announced his agency would focus on 4 goals:

Facilitate product development

Gottlieb proposed reimbursement reforms that could include milestone payments or subscription fees for drug makers that create FDA-approved products targeted at multidrug-resistant organisms and associated with proven clinical outcomes.

He noted that large pharma companies are exiting the business, and current reimbursement strategy runs opposite to what is needed in public health to fight AMR: to create a drug, but not use it unless absolutely necessary. To that end, Gottlieb proposed that hospitals could pay subscription fees to have access to a new drug, paying a flat rate for a certain number of doses if the drug were linked to proven clinical outcomes.

New payment mechanisms would allow drug firms “to capture a greater upfront share of the social value of antibiotic drug development,” he said. He noted that the CDC estimated that the direct costs of antimicrobial resistance on the economy is $20 billion annually; including the consequences of lost productivity adds an additional $35 billion in costs.

Technology add-on payments for certain new antibacterial drugs could be another way to spur investment, Gottlieb said.

Support antibiotic stewardship

Gottlieb said promoting antimicrobial stewardship, including in animal health as well as in human health, “can help preserve the effectiveness of available treatments and may help slow the development of antimicrobial resistance.”

The FDA will work to bring the remaining 5% of medically important antimicrobials approved for use in animals under veterinary oversight, and will release a guidance document to assist industry.

In addition, the agency will work to see that antimicrobials are labeled with appropriately defined durations of use related to food-producing animals—the FDA said that about 40% of antimicrobial drugs used in feed and water include at least 1 indication that doesn’t have a defined duration of use.

The FDA said it will work with the US Department of Agriculture (USDA), veterinary medical associations, and academic institutions to create updated veterinary curricula.

In human health, the FDA said it is working closely with manufacturers and academia on the next generation of biomarkers to rapidly identify whether a patient’s symptoms are due to a bacterial infection, or to know when antibiotics can be stopped. It is also seeking the development of new devices that can identify bacteria or fungal pathogens directly from specimens such as blood, spinal fluid, stool or sputum, without waiting for growth in cultures.

Increase surveillance of antimicrobial use

Gottlieb cited the National Antimicrobial Resistance Monitoring System (NARMS), co-managed by FDA, USDA, and CDC, and said the veterinary center plans further improvements to NARMS, such as expanding NARMS sampling, supporting research in advanced genomic technologies and bioinformatics, and building capacity to monitor AMR in previously underexplored pathogens to include companion animals and animal feed.

The agency is also seeking to refine industry reporting of antimicrobial sales data and gain a better understanding of how these products are used on farms.

In human medicine, the FDA seeks to reduce inconsistency in reporting test results from hospitals about antimicrobial resistance. The FDA’s Office of In Vitro Diagnostics and Radiological Health has led the development of interoperable data standards for the transmission of device codes from manufacturers to clinical laboratories, supporting the development of a microbiology-coding manual, he said.

Enhancing regulatory science

Gottlieb said the agency is developing methods to assess medical countermeasures and validating next generation in vitro diagnostics platforms. It is also working with public-private partnerships to inform approaches to drug development, facilitate guidance development and provide recommendations to streamline efficient development.