June 12, 2018
Due to a growing incidence of antibiotic-resistant strains of bacteria, FDA Commissioner Scott Gottlieb, MD, recently outlined the steps the FDA will take to fight the current issue as well as seek new solutions.
“The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients,” Dr Gottlieb said in a statement. “According to our colleagues at the Centers for Disease Control and Prevention, each year in the United States at least 2 million people become infected with bacteria that are resistant to antibiotics and 23,000 people die each year as a direct result of these infections.”
According to Dr Gottlieb, it is important that the FDA ensure good antibiotic stewardship and use in appropriate clinical scenarios. However, he explained that overall, there has been a decline in antibiotic drug research due largely in part to development obstacles in this category—despite the growing threat of resistance.
Currently, many patients with infections may have already tried several currently available antibiotics before a clinical trial is considered. Due to this, patients may have received substantial treatment for their infection before enrolling in a clinical trial, and their exposure to other treatments may make it more difficult to isolate the effects of an investigational drug.
Further, the development of new drugs can be costly, Dr Gottlieb explained. However, he said, “the current reimbursement model, where drugs are reimbursed based on each episode of their use, presents incentives that run contrary to effective stewardship over new antibiotics that might be highly effective against very rare and dangerous pathogens.”
In an effort to combat these drug-resistant infections, the FDA announced they are working with other federal agencies to address each challenge as well as develop new efforts to address the need for better economic incentives.
The first step Dr Gottlieb outlined included implementing a set of special incentives that Congress created for the development of antibacterial and antifungal drugs that treat serious or life-threatening infections, such as the qualified infectious disease product designation. Under this program, new drug applications could potentially receive fast track designation, priority review designation and a possible five-year extension of any exclusivity that the application qualifies for upon approval.
Another step outlined by the FDA Commissioner included discussions with other agencies such as the CMS. He explained that working with the CMS would “involve changing the model for reimbursement of certain new, anti-microbial drugs that meet critical, public health needs—principally their ability to effectively target dangerous, multi-drug resistant infections.” Dr Gottlieb said that under this approach with the CMS, instead of paying for drugs that meet a narrow set of critical, public health criteria, drug payments might move to a licensing model.
“Under such a model, the acute care institutions that are most likely to prescribe these medicines would pay a fixed licensing fee for access to the drug, which would offer them the right to use a certain number of annual doses,” he explained.
Dr Gottlieb expressed that all of the concepts created by the FDA are still being developed and they hope to engage with the public about these ideas. Further he explained that the Agency is taking other steps to help advance the development of improved antimicrobial drugs through measures that make the development process more predictable and efficient.
“While we hope our work will help advance the development of new antibacterial and antifungal drugs, this isn’t a problem that can be addressed by our agency alone,” he said. “We’re collaborating with agency partners, the broader scientific and policy community, and medical product sponsors to address scientific challenges.”
He stressed that bacteria will continue to evolve, and that it will continue to stop the usefulness of available treatment.
“More judicious use of antibiotics in health care and agriculture settings can help slow the rate at which bacteria become resistant to antibiotics,” Dr Gottlieb concluded. “But even with prudent use, we will need to continuously encourage the development of new therapeutic options to keep pace with these challenges.”
For more Pharmacy Learning Network articles, visit the homepage
To learn about Pharmacy Learning Network Live meetings, click here