Experts agree that antibiotics have been overused by doctors and livestock producers and under-researched by drug companies, which is why substantive strategies for developing new drugs to fight bacterial infection are needed. Two examples of substantive strategies include a federal program that encourages the pharmaceutical industry to develop new antibiotic drugs, and a proposed California law that would limit the use of antibiotics in animal feed.
For decades, doctors who treated infections empirically with antibiotics did so with the best intentions for the welfare of their patients, and livestock producers who mixed antibiotics into their animals’ feed were following what they felt to be best business practices. In response to this overuse of antibiotics, the bacteria the drugs are designed to fight have evolved, and are continuing to evolve, resistance.
Despite need for robustly effective antibiotics to combat these newly emerging superbugs, there are very few new antibiotic drugs in the research pipelines of pharmaceutical companies. Because new drug development is such an expensive and time-consuming process, pharmaceutical companies have not found it cost-effective over the last few decades to develop new antibiotics. The companies can ensure larger, more stable, returns on their new drug development investments by developing drugs that target chronic diseases.
This industry trend of antibiotic overuse and under-research has created an urgent need worldwide for substantive new drug development strategies. While antibiotic stewardship programs for medical practitioners can help conserve the efficacy of the antibiotics that are currently available, strategies aimed at providing incentives for developing new antibiotics and stopping antibiotic overuse are not just needed but necessary.
One example of a successful federal program aimed at developing new antibiotics is the Biomedical Advanced Research and Development Authority (BARDA), which was initiated in 2010 under the auspices of the U. S. Department of Health and Human Services. BARDA’s Broad Spectrum Antibiotics (BSA) program is designed to change the way pharmaceutical research is funded in an effort to revitalize the drug pipeline with new antibiotics. The BSA program helps drug companies navigate the Food & Drug Administration’s (FDA) new drug approval process in innovative ways that save both time and money. Since the BARDA program began, three new antibiotics have entered the FDA approval process.
An example of a state-level effort to prevent antibiotic overuse is a California legislation (Senate Bill 835) that would ban the use of antibiotics for promoting livestock growth and would require a veterinarian’s prescription to obtain livestock antibiotics. The bill is designed to mirror FDA’s Guidance for Industry #213, which aims to phase out the use of antibiotics to promote growth in food animals nationwide. Supporters of the CA bill point to a need to align state law with federal policy. Opponents claim the legislation would be ineffective in reducing antibiotic use in livestock because it would allow current practices to continue under different labels, names and descriptions. Opponents also point out that the bill does not provide a means for tracking whether antibiotic use increases or decreases as a result of the ban.
Whether the changes in society’s approach to the production and consumption of antibiotics happen at the federal, state or industry level, the time to make them is now. The substantive strategies for ensuring the future of antibiotic drug development will need to address specific ways of halting antibiotic overuse and provide incentives to industry to ensure that antibiotics, as a drug class, do not remain under-researched.
By Lane Therrell
Food Safety News
USDHHS (How is BARDA Positioned to Respond to the Threat?)
USDHHS (Using Innovative Business Models to Enhance Antibiotic Development)
National Center for Biotechnology Information