US FDA ups the ante against antimicrobial resistance

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/ClaudioVentrella)
(Image: Getty/ClaudioVentrella)

Related tags: AMR, Antibiotics, Fda

The US FDA announced a number of measures it considers as a viable means of combatting AMR, including the idea of hospitals paying a ‘subscription’ to access new medicines.

According to the World Health Organization (WHO), antimicrobial resistance (AMR) is present in every country around the world​ and is increasing across a number of disease areas, such as HIV and tuberculosis.

With the threat posed by AMR increasing, there is an increased demand for measures to counter this trend and the US Food and Drug Administration (FDA) has released launched a new webpage​ addressing the challenge.

In a speech at The Pew Charitable Trusts, FDA commissioner Scott Gottlieb outlined four key ways that the Agency is engaged in to counter AMR:

First, we’re facilitating product development to ensure a robust pipeline of safe and effective treatments that can combat resistant organisms.

Second, we’re promoting antimicrobial stewardship. Careful stewardship across human and animal health can help preserve the effectiveness of available treatments and may help slow the development of antimicrobial resistance.

Third, we’re supporting the development of tools for surveillance of antimicrobial use and for determining when pathogens develop resistance. 

Finally, we’re advancing scientific initiatives to help all stakeholders answer critical questions related to antimicrobial resistance. This includes research that can support the development of alternative treatment approaches. These can include bacteriophages, faecal microbiota transplants and live biotherapeutic products.

In regards to his first point, Gottlieb focused on the ways in which reimbursement of new medicines could increase the development in the space. He stated that a “subscription-based model” ​could be adopted, which would see hospitals paying a “flat rate” ​to gain access to newly developed drugs.

The fee that would be charged for the medicine, Gottlieb suggested, should be at a level that would provide companies investing in the area sufficient return as to make initial R&D costs viable.

A number of larger companies have dropped out of looking to develop new antibiotics and antimicrobials due to lack of return; in July of this year, Novartis became the latest company to exit the space​.

Gottlieb recognised this issue in his speech, “Large pharmaceutical companies have, for the most part, exited from antibiotic research. And while some small, venture-backed, start-up companies remain engaged, these companies are not as well positioned to fund the larger confirmatory trials required for regulatory approval.”

However, outside of big pharma investment, Gottlieb stressed that the Agency is noting some success in pushing for new developments in the space:

New developments against AMR are also emerging at the early stages of research, such as the work by Arizona State University and the Mayo Clinic looking into the antimicrobial potential of natural clays​.

Related topics: Regulatory & Safety, Regulations

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