Both paths to approval have flaws. "The FDA has had conference after conference with infectious disease experts. We have made little progress in negotiation and have no new antibiotics at a time when resistance is rising, and it’s critical that we develop more," he said.
Time may be running out. Before the advent of penicillin in 1928, infection was the leading cause of death worldwide; in 2000, it was still the fourth-leading cause of death. "If our antibiotics stop working, we will rapidly go back to those pre-World War II days when all we had to treat infections were arsenic and sulfa. Yes, that’s a doomsday scenario, but it’s not inconceivable that we could once again live in a time when infections reign supreme," he concluded.
The FDA issued the following statement:
"The development of new antibacterial drugs is an important public health issue and one that the Food and Drug Administration is working with academia and industry to address. FDA plays an important role in providing recommendations to companies on the types of trial designs to use to study a new drug.
Antimicrobial resistance is a problem. We need new therapeutic options to treat resistant bacteria and we will continue to need new therapeutic options in the future to treat patients with infections.
There are scientific, economic, and regulatory challenges that affect the development of new antibacterial drugs. Based on our current understanding of a number of infectious diseases, antibacterial drug effects, and clinical trial design, it is clear that some clinical trial designs used in the past were not an informative means to evaluate drug effectiveness.
The FDA is working to update guidance and meets with companies developing antibacterial drugs in to provide advice on their development programs so that they will be designed to meet the efficacy standards established by law. As part of these efforts, the FDA recognizes the need for approval pathways which are feasible.
The challenges we are facing in antibacterial drug development are largely scientific, and the path forward must be supported by sound science. To that end, the FDA has engaged scientific experts, including members of the Infectious Disease Society of America, in a series of recent public workshops and advisory committee meetings.
Draft guidance documents have been issued for acute bacterial otitis media, acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis, community-acquired bacterial pneumonia, noninferiority clinical trial design, and acute bacterial skin and skin structure infections. And a draft guidance document for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia will be issued in the coming months.
In addition to publishing guidance documents, the FDA meets with companies developing new antibacterial drugs and provides advice throughout drug development. The Agency looks forward to continuing to work with scientific experts to address the challenges of new antibacterial drug development."
Disclosures: Dr. Rosen reported having no relevant financial disclosures.