Research Calls for Regulators to Accelerate the Approval of Antibiotics

Report by One Health Trust says acknowledging antimicrobial resistance in regulatory frameworks for accelerated drug approval could improve access to new antibiotics.

A report assessing the current climate for antimicrobial innovation in Brazil, India, and South Africa, reveals that removing regulatory hurdles to accelerate the approval of new antibiotics will help to improve their development and access.Antimicrobial resistance (AMR) is a growing challenge to the healthcare sector, as antibiotics are a linchpin of modern medicine. The appropriate use of existing antibiotics and the development of new antibiotics targeting drug-resistant infections can slow the emergence, spread and consequences of AMR.Yet despite the need for new antibiotics, R&D has failed to respond, primarily because antibiotics are costly to produce, and their low prices and restricted use do not make their development economical. According to the report, though financial incentives and market reforms are critical for sustainable progress, addressing regulatory hurdles to accelerate approval of new antibiotics can also help improve their development and access.Director of One Health Trust, Dr Ramanan Laxminarayan, commented: “Antibiotics are different from other drugs in many respects, including the need for the periodic introduction of new drugs to replace ones to which resistance has developed and the complexity of trials to identify drugs that are effective against drug-resistant pathogens.”In a report supported by the AMR Industry Alliance, One Health Trust described the current climate for antimicrobial innovation, focusing on regulatory challenges and opportunities for the approval of new antibiotics in Brazil, India, and South Africa.

The landscape analysis performed highlights the importance of explicitly recognising new antimicrobials targeting serious or life-threatening infections as a critical unmet medical need, formalizing their inclusion in regulatory frameworks for accelerated drug approval.

The recommendations provided to accelerate the approval of antibiotics include:

Creating a specific category for antimicrobials that target serious and life-threatening infections within the regulatory framework provided for accelerated approval pathways.
Leveraging existing programs for expedited approval for drugs targeting TB, HIV, and COVID-19 to accelerate the approval of antimicrobials targeting serious and life-threatening infections, such as multidrug-resistant infections.
Increasing regulatory authorities’ capacities to deal with the complexity of AMR and novel clinical trials.
Promoting regulatory harmonization to facilitate the adoption of reliance pathways for accelerated approval of antimicrobials.

Dr Laxminarayan also noted: “Much has been written about the growing morbidity and mortality caused by antibiotic resistance, especially in low- and middle-income countries. The problem is frequently blamed on the overuse of antibiotics and appropriately so, but insufficient attention has been given to the underlying problem of lack of access to antibiotics. Appropriately, this report identifies the acknowledgment of AMR in regulatory frameworks for drug approvals as an opportunity to improve the wider availability of new antibiotics.”