Emergence of new antibacterial agents
The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) met at the EMA headquarters to debate over promoting the evolution of new antibacterial products.
Antimicrobial resistance (AMR) is regarded as a global threat to public health, with the World Health Organization (WHO) calling AMR "so serious that it threatens the achievements of modern healthcare." One of the main challenges to tackle AMR has been for making new products to fight bacterial infections. Recently, no new classes of antibiotics have been approved despite recent attempts like Generating Antibiotics Now Act (GAIN Act) in the US and the European Commission's action plan against AMR.
In June, FDA's Center for Drug Evaluation and Research (CDER) Director Janet Woodcock went so far as to say the pipeline for new antibiotic drugs is "fragile and weak," and focused on the difficult nature of testing such drugs. Woodcock said," How do you find these people who are infected, who are maybe scattered around, and then test a drug in them when they are critically ill and they need to be treated right away? So these clinical trials, even small clinical programs, are extremely challenging."
Role of Regulators?
Keeping challenges in mind, FDA, EMA and PMDA agreed on actions they can take to enable the development of new antibacterial products. The agencies said "It is appropriate to exercise flexibility with regard to the requirements for clinical development programmes for antibacterial agents, especially for new agents that may be used to treat patients with limited treatment options because of antimicrobial resistance." Regulators say they can assist by allowing drug makers to use the same data for submissions to all three agencies. They confessed that they may have to acquire more uncertainty about the benefits and risks for antibacterials used in situations where there are "limited treatment options." The agencies stated that "It may be acceptable to conduct trials in smaller numbers of patients than would usually be required."
As per EMA "Regulatory activities are only one element of the comprehensive and multifaceted response needed to encourage and accelerate development of new antibacterial medicines that meet patient needs."
NIH AMR Competition
In the US, the National Institutes of Health (NIH) are searching to tackle AMR through a new competition offering $20 million in prizes for the development of new diagnostics for uncovering drug-resistant bacteria. The competition is financed by NIH and Biomedical Advanced Research and Development Authority (BARDA), with technical and regulatory assistance from the US Centers for Disease Control and Prevention (CDC) and FDA. Prize money can be utilized to develop prototypes for evaluation by two CLIA-certified independent laboratories, which will be considered after selecting winners.