By Natalie Mulloy, NACCHO Government Affairs Intern
According to the Centers for Disease Control and Prevention (CDC), antibiotic or antimicrobial resistance is one of the most pressing health challenges in our nation. Antibiotic or antimicrobial resistance occurs when microbes are able to spread despite the treatment of drugs, placing individuals at high risk for death. Recently, an E.coli bacteria carrying the mcr-1 gene, which makes bacteria resistant to a last-resort antibiotic called colistin, was found in the urine of a woman in the U.S. This type of gene is highly transferable and calls for aggressive action to prevent the spread of resistance any further.
The most prevalent factor contributing to antimicrobial resistance is the inappropriate distribution of antibiotics. In fact, 50 percent of antibiotic prescriptions are given unnecessarily. Consequently, each year in the U.S., at least 2 million people become infected with antibiotic-resistant bacteria and at least 23,000 people die annually as a direct result of these infections (CDC, 2016).
NACCHO recognizes that antimicrobial resistance represents a growing threat to the health of the public, and encourages federal and state partners to support and fund local health departments so that they can develop and implement policies and strategies to address the issue. NACCHO has passed the following policy statements related to this topic:
- Antimicrobial Stewardship and Antimicrobial Resistance
- Multi-Drug Resistant Organisms
- Healthcare-Associated Infections
- Antimicrobials in Animals
- National Healthcare Safety Network
Further, NACCHO and 30 other diverse organizations supported an amendment to the National Defense Authorization Act (NDAA) authored by Senators Bennet (D-CO), Hatch (R-UT), Blumenthal (D-CT), and Kirk (R-IL) that included the language of the Promise for Antibiotics and Therapeutics for Health (PATH) Act (S.185). The letter gave a sense of urgency when mentioning the first case of colistin-resistant strain found in the United States.
Promise for Antibiotics and Therapeutics for Health (PATH) Act (S.185)
The PATH act was introduced in the Senate on January 16, 2015, and has since been passed by the Senate Health, Education, Labor, and Pensions (HELP) Committee. The key provisions of the legislation include the establishment of a new “limited population antibacterial drug” (LPAD) approval pathway for antibiotics to treat serious or life-threatening infections for which there exists an unmet medical need. This act amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish this program. The PATH act will allow for smaller, faster clinical trials so that new antibiotics can be brought to market sooner, with necessary safety measures in place.
There are special precautions taken for these limited population drugs to ensure their safety. Before the drug is released, the FDA requires a pre-review of promotional materials and creation of a specific drug label to clearly display that the drug is only approved for limited populations. Once public, a strict mechanism is followed to monitor the drug’s use and potential changes in bacterial drug resistance. If the drug eventually passes approval for broader use, the FDA is allowed to remove the labeling, marketing, and monitoring requirements. These safeguards put in place by PATH are essential for the success of the LPAD pathway to address antimicrobial resistance.
Who Leads the Fight?
On June 14, the Energy and Commerce Committee, Subcommittee on Oversight and held a hearing in response to the antibiotic-resistant bacteria in the recent news. Representatives from agencies receiving funding were there to discuss their contribution and answer questions from the committee. The discussion highlighted the collaborative work of the Biomedical Advanced Research and Development Authority (BARDA) and National Institutes of Allergy and Infectious Disease (NIAID). In February of this year, the organizations announced that they will be working on a Combating Antibiotic Resistant Bacteria (CARB) Biopharmaceutical Accelerator, which will allow public-private partnerships to support research and development (R&D) to accelerate novel products (i.e., drugs, vaccines, and diagnostics) into clinical trials.
A representative from the CDC elaborated on their Antibiotic Resistance Solution Initiative, which received $160 million in FY2016. CDC hopes to expand this initiative if appropriated an additional $40 million in FY2017. NACCHO has supported this funding increase. Lastly, the FDA discussed the Generative Antibiotic Incentives Now (GAIN) Act (H.R. 2182), passed in 2012. The GAIN act allows the FDA to fast-track and priority review antibiotics and give an economic incentive to increase drug exclusivity by five years. Since 2013, at least 16 antibiotics have qualified under GAIN, and implementation is ongoing.
The PATH Act currently awaits Senate floor action; without it, many of the antibiotics that patients need will not be able to be developed. In the interim, key players continue to advocate for legislation and awareness.
NACCHO is part of the U.S. Stakeholder Forum on Antimicrobial Resistance (S-FAR). With help from local health departments, S-FAR is planning to publish a collection of stories of people who have been affected by this problem firsthand. If you or one of your loved ones, patients or colleagues has suffered from an antimicrobial-resistant infection and are willing to share the story, please contact Colin McGoodwin with the Infectious Diseases Society of America.
Be sure to check out NACCHO’s Legislative Action Center to see if your Senator(s) has sponsored this bill. If not, you can contact their health legislative assistant and, where possible, reach out to your legislators via social media to ask for support.