Officials with the Infectious Diseases Society of America are advocating an approach that would ultimately allow the FDA to review certain antibiotics similar to how it reviews drugs for rare diseases.
In a statement to the House Energy and Commerce Committee, Subcommittee on Health, IDSA members said research and development for antibiotics is extremely difficult in the United States, but new antibiotics are sorely needed, particularly for resistant strains such as methicillin-resistant Staphylococcus aureus and tuberculosis. Unfortunately, many pharmaceutical companies have turned away from antibiotic research because it is generally an unprofitable area of research characterized by significant development hurdles. However, many researchers argue that granting certain antibiotics “orphan” status would entitle the developers to quicker review processes and possible longer lengths of trademark protection.
In the statement, the IDSA backs a plan that would develop antibiotics for certain conditions under the Special Population Limited Medical Use (SPLMU) framework, which would create new approval pathways for antibiotics, including offering them orphan drug status.
“Antimicrobial resistance is unequivocally one of the world’s greatest public health threats, and we’ve been sounding the alarm about it — and the lack of new antibiotics in development — for years,” Brad Spellberg, MD, co-chair of IDSA’s Antimicrobial Availability Task Force, said in a press release. “This new mechanism provides the opportunity to address this public health crisis while there is still time to fix it.”
In the statement, IDSA members also ask that the Institute of Medicine help the FDA streamline its design of clinical trials for antibiotics.
Another way to mitigate the antibiotic crisis, according to the IDSA’s statement, is to make rapid and accurate diagnostic tests available to physicians so that unnecessary antibiotic treatment is minimized. IDSA members suggested a centralized specimen biorepository to strengthen infectious disease research and diagnostics development. Lastly, IDSA officials recommended an antimicrobial stewardship initiative.
“Losing antibiotics entirely — which is where we are heading without urgent action — will undermine the way medicine is practiced and have devastating consequences for patients,” IDSA members wrote in their report. “We have an obligation to our children and grandchildren to invest in the development of new antibiotics and related diagnostic tests and to preserve antibiotics’ effectiveness for the long term.”
IDSA members submitted the proposal during a hearing on the FDA’s Prescription Drug User Fee Act (PDUFA) reauthorization legislation.