FDA's efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections
In a new statement, FDA Commissioner Scott Gottlieb, MD, discusses the growth of serious antimicrobial drug-resistant infections in the United States.
In a new statement, FDA Commissioner Scott Gottlieb, MD, discusses the growth of serious antimicrobial drug-resistant infections in the United States. Calling the issue "a critical public health concern and a growing threat to patients," he notes some of the scientific and economic challenges in antibiotic drug development, such as developers' hesitance to make significant investments in a product when they know there will be a very limited market for it. To that end, one step being taken is implementing a set of special incentives that Congress developed for antibacterial and antifungal drugs that treat serious or life-threatening infections. Gottlieb explains that under the program, new drug applications that receive the qualified infectious disease product designation can receive fast-track designation, priority-review designation, and a possible 5-year extension of any exclusivity that the application qualifies for upon approval. He also says, "One idea that we're currently discussing with other agencies such as the Centers for Medicare and Medicaid Services would involve changing the model for reimbursement of certain new, antimicrobial drugs that meet critical, public health needs—principally their ability to effectively target dangerous, multidrug-resistant infections." These ideas are still being developed, Gottlieb adds, noting he hopes there will be more public engagement around these concepts. He says the agency is also taking steps to help further development of improved antimicrobial drugs, with measures that increase the efficiency and predictability of the development process. FDA has issued draft guidance to aid in the development of drugs using the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway). When finalized, the guidance will support drug development by listing the criteria, processes, and other general considerations for drugs approved under the LPAD pathway. In addition, it will help companies in developing labeling to inform the medical community that the drug was approved under this important pathway based on a benefit-risk assessment in a limited population.