The US Food and Drug Administration (FDA) is preparing to launch a new FDA-only task force set on supporting the development of new antibacterial therapies, part of the provisions of the recently passed FDA Safety and Innovation Act (FDASIA).
The task force was prescribed as part of FDASIA's "Generating Antibiotic Incentives Now (GAIN)" title, intended to grant new incentives for developers of antibiotic therapies. Those incentives include additional years of market exclusivity beyond those granted by patents, priority review status by FDA and additional meetings with FDA to work through possible regulatory hurdles.
The need for such incentives is particularly urgent given the role of drug-resistant bacterial strains in causing serious injuries in hospitals and the diminishing supply of antibiotics with which to fight those strains, FDA explained. "More than 70 percent of the bacteria that cause hospital-associated infections (HAIs) are resistant to at least one type of antibacterial drug most commonly used to treat these infections."
The net result: nearly 100,000 deaths in the US each year, and another 1.9 million non-fatal infections.
FDA hopes to tackle this problem head-on, and has assembled 19 of its staff members charged with assessing what can be done-a veritable who's who of the agency's drug regulators at the Center for Drug Evaluation and Research (CDER): Robert Temple, John Jenkins, Rachel Sherman, Edward Cox, Lisa LaVange and Melissa Robb.
Between them, the group represents 10 offices and divisions within CDER, with the most coming from its Division of Anti-Infective Products and Office of Antimicrobial Products.
"The creation of this new task force comes at a critical time," said Cox, director of the Office of Antimicrobial Products in CDER. "Establishing new ways of developing safe and effective new antibacterial drugs is an enormous challenge and not an effort that can be accomplished alone."
Regulatory Issues at Heart of Assessment
The task force will seek to tackle four larger issues, claims FDA. Among them:
- exploring regulatory issues associated with the use of clinical pharmacology data and other statistics, as well as the use of innovative clinical trial designs and new methods of evaluation
- the identification of unmet medical needs for antibacterial drugs and ways to enhance upstream development and research
- re-examining existing guidance documents and regulations to determine if the existing regulatory structure is accommodating the development of new antibiotic treatments and, if not, where clarification or changes are needed
- the use of new, cross-cutting agreements between FDA and other third parties, such as think tanks, to broaden the pool of ideas the agency is considering
FDA officials said the end goal of the project is to promote a paradigm shift in how the agency receives, reviews and approves new antibacterial products. "Our hope is that this effort will result in important new breakthroughs in the field of antibacterial drug development and help in the fight against antibiotic resistance," Sherman, associate director of medical policy for CDER, said.