Guest commentary: IDSA president urges action as Get Smart About Antibiotics Week kicks off

Today is the start of Get Smart About Antibiotics Week — an annual weeklong observance to raise awareness about the growing threat of antibiotic resistance and the importance of appropriate antibiotic prescribing and use. In this guest commentary, William G. Powderly, MD, president of the Infectious Diseases Society of America, discusses “concrete actions” federal agencies and lawmakers can take to advance the nationwide fight against antibiotic resistance, which represents a global health crisis.

IDSA has been a long-standing partner of the CDC’s Get Smart About Antibiotics Week. But this year is different. This year, we are on the cusp of unprecedented opportunities to significantly reduce inappropriate antibiotic use. In addition to supporting Get Smart’s efforts to educate the public about antibiotic use, we must also ensure that our federal leaders take the necessary steps to realize enormous and attainable progress for patients and public health.

The following concrete actions can bring forward meaningful changes for the battle against antibiotic resistance this year:

William G. Powderly

CMS should finalize the proposed Condition of Participation to require all acute care hospitals to implement antibiotic stewardship programs.
Congress can enable the FDA to more rapidly update antimicrobial susceptibility breakpoints.
Congress can provide the CDC with the funding needed to support robust surveillance and data collection.
Congress can enact legislation to establish the Limited Population Antibacterial Drug (LPAD) approval mechanism.

Earlier this year, CMS proposed a new Medicare Condition of Participation that would require antibiotic stewardship programs in all hospitals. Such programs have been found to reduce inappropriate antibiotic use, reduce health care costs, and improve patient outcomes. This policy is a key component of the National Action Plan for Combating Antibiotic-Resistant Bacteria. The Obama Administration’s prioritization of antibiotic resistance has catalyzed recent progress, and IDSA strongly urges CMS to finalize its proposed stewardship rule before the end of this Administration.

To effectively practice stewardship, physicians need diagnostics to help identify infecting pathogens and assess antimicrobial susceptibility. Antimicrobial susceptibility test (AST) devices rely upon susceptibility breakpoints, which must be updated to keep pace with increasing resistance. Unfortunately, the current FDA process for updating breakpoints is too time-consuming and cumbersome, often leaving physicians without the up-to-date information they need to guide patient care. A provision in the 21st Century Cures Act, H.R. 6, would significantly streamline this process by allowing the FDA to use external standard-setting organizations, if deemed appropriate, to update drug labels and AST devices, and establishes a new website for the most updated breakpoint information. H.R. 6 was approved by the U.S. House of Representatives with strong bipartisan support, and IDSA is strongly urging the Senate to pass a final version of this legislation this year. In addition, IDSA also welcomes the draft guidance recently issued by the FDA on coordinated development of antimicrobial drugs and AST devices, and urges continued efforts to shorten the time between when a new antimicrobial drug is approved and the corresponding AST device is made available.

The CDC is working closely with state health departments and hospitals to strengthen stewardship activities, data collection and surveillance. Data on antibiotic use is essential to allow us to assess the impact of stewardship interventions, identify areas for improvement, and determine best practices. The CDC collects these data through the National Healthcare Safety Network, but many hospitals still need assistance to be able to report through this mechanism. In addition, real-time surveillance of emerging resistance threats and patterns is crucial to inform stewardship protocols and other public health responses. The CDC needs appropriate resources to advance this work, and we call upon Congress to pass a final 2017 appropriations bill that provides this funding during the lame-duck session.

Lastly, we must recognize that even ideal stewardship efforts cannot stop resistance entirely. We will still need a robust and renewable antibiotic pipeline for current and future threats. Unfortunately, significant obstacles continue to thwart antibiotic research and development. For example, it is extremely difficult to enroll a sufficient number of patients in clinical trials for antibiotics to treat some of the deadliest, highly resistant pathogens, because these pathogens are currently infecting a relatively small number of critically ill patients. The LPAD proposal would allow new antibiotics that would address an unmet medical need to be studied in smaller, more rapid clinical trials and approved only for the limited population of patients who most need them. This proposal would not only allow some of the most urgently needed new antibiotics to be developed and brought to market, but it would also facilitate stewardship by allowing these drugs to have narrow indications. LPAD was included in the 21st Century Cures Act, and IDSA strongly encourages Congress to enact this important legislation this year.

This week is not only Get Smart About Antibiotics Week, it is also World Antibiotic Awareness Week. The recent United Nations high- level meeting on antimicrobial resistance (AMR) and the resulting U.N. political declaration on AMR demonstrate that momentum to address this public health crisis exists not just in the U.S., but globally as well. This year, raising awareness about antibiotic use and resistance is not enough. This year, we must seize the opportunities to enact change.

For more information:

William G. Powderly, MD, is the Larry J. Shapiro Director of the Institute for Public Health, the J. William Campbell Professor of Medicine, and co-director of the division of infectious diseases at Washington University School of Medicine in St. Louis.

Disclosure: Powderly is a member of advisory boards for Merck and Gilead.