With antibiotic-resistant superbugs seemingly uniting public health groups around developing new antibiotic drugs, FDA signaled last week that it got the message and will respond soon. While FDA offered few details, Commissioner Margaret A. Hamburg, M.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, offered an outline of how the agency will address the issue.
“We are working to provide scientifically sound guidance to industry on demonstrating the safety and effectiveness of new antibacterial drugs, particularly on indication-specific trial designs used to study a new drug,” Dr. Woodcock testified March 8 before the Health Subcommittee of the House Energy and Commerce Committee.
“Although the development of new antibacterial drugs is not the entire solution to the important public health problem of antimicrobial resistance, it is a very important part,” she added. “We are at a critical juncture in this field. We are in urgent need of new therapeutic options to treat the resistant bacteria that we currently face, and we will need new therapeutic options in the future.”
Dr. Woodcock said FDA is in talks with industry representatives, the Infectious Disease Society of America (IDSA), and others about how drugs should be developed for multidrug-resistant organisms: “A much abbreviated development program, a very small development program, which would be an incentive for developing these types of antibiotics would be highly feasible if it were linked to the concept of good antibiotic stewardship post-market.”
Stephanie Yao, an FDA spokesperson told GEN, “The FDA has been working on a number of efforts to provide industry with updated guidance on recommended clinical trial designs for antibacterial drug development for a variety of conditions. Over the past five years, the agency has issued 10 guidance documents, either as drafts or final, in the area of antibacterial drug development and breakpoints.”
Dr. Woodcock pointed out that antibacterial drug development faces several scientific and business challenges: the difficulty of designing clinical trials due to small patient populations; a lack of standardized data; and a decline in funds targeted to developing new drugs.
Additionally, antibiotics are typically priced much lower than most drugs and used for shorter durations than drugs for chronic illnesses, Amanda Jezek, IDSA’s director of government relations, pointed out to GEN. “Chronic drugs are much more profitable for companies than antibiotics, so it’s very challenging to get companies to direct their resources to this space.
“And we also typically want to make sure that antibiotics are not overused,” and thus breed resistance to the drugs, she added. “There are so many challenges to antibiotic development, which underscores the need for some creative thinking about how to get some companies back in the game of developing antibiotics,” Jezek remarked.
One example of the scientific challenge emerged last month. Researchers from Columbia University Medical Center, NIH, and St. George’s University of London detailed how methicillin-susceptible S. aureus (MSSA) clone ST398-NM has emerged as a significant cause of community-associated infections in humans in the U.S., Europe, and China. Based on samples from 332 Manhattan households, scientists determined ST398-NM efficiently transmits from person to person in part because it adheres well to human skin.
The goal is less curing the disease with drugs than preventing it in healthy people: “Perhaps understanding the risk of a certain strain would help us actually to devise interventions other than drugs,” the study’s lead author Anne-Catrin Uhlemann, M.D., a Columbia researcher, told GEN. “I think it’s more about learning what happens at the molecular epidemiology interface, understanding what these strains mean, and then changing behavior and being preventive.”