In advance of the 2016 budget proposal, the White House has tipped its hand on one big priority: the fight against antibiotic resistance. A fact sheet released today describes how President Barack Obama plans to double the government's investment in combating the mounting public health crisis of drug-resistant infections by spreading roughly $1.2 billion in funding across several federal agencies.
That sum includes $650 million for the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) to study mechanisms of resistance in bacteria and promote the development of new antibiotics and diagnostics. Funding for NIH would also support a clinical trial network that would let drug developers more easily collect data across multiple clinics, according to the fact sheet.
The U.S. Centers for Disease Control and Prevention would receive $280 million for monitoring and research, including the addition of 10 sites to its Emerging Infections Program. The fact sheet also hints at two new programs: a detection network to identify new outbreaks and a comprehensive “isolate bank” to collect known resistant bacteria.
Meanwhile, the Food and Drug Administration would receive $47 million to evaluate new drugs and diagnostics and to continue its efforts to phase out the use of certain antibiotics in feed animals—a major threat to the value of these drugs as human medicines. The Department of Agriculture would also see a quadrupling of its funding to explore alternatives to antibiotic use in livestock.
The comprehensive approach closely follows recommendations from a recent report from the President's Council of Advisors on Science and Technology, notes Amanda Jezek, vice president of public policy at the Infectious Diseases Society of America in Washington, D.C. “This seems to be what we were hoping for in terms of next steps,” she says.
The proposal is the latest in an international effort to revitalize research and drug development on antibiotics—a historically inhospitable industry for big pharmaceutical companies. The short course of treatment for antibiotics and physicians’ desire to withhold the most effective drugs for future emergencies make it hard for companies to turn a profit. And in the scientific quest to identify new targets for antibacterial drugs, “the low hanging fruit has been picked,” says Gail Cassell, a drug company executive and visiting scholar at Harvard Medical School who chairs a task force on antimicrobial resistance for the American Society for Microbiology.
But the new funding is likely to stimulate development, says Cassell, who praises in particular the White House’s emphasis on new diagnostics. Doctors desperately need ways to detect resistant microbes and choose the right treatment quickly, without waiting days for lab results. Earlier this year, the White House announced that NIH and BARDA would co-sponsor a $20 million prize for a quicker test to recognize highly resistant infections. But Cassell points out that companies developing these technologies face other barriers—notably the complexities of health care reimbursement for their products—that can’t be addressed with a government funding boost alone.
Jazek expects this part of the budget proposal to meet with friendly ears in Congress—both the House of Representatives and the Senate have prioritized the issue and have proposed bills to create an accelerated approval pathway for new antibiotics, she points out. “The federal budget picture is going to be challenging,” she says, but in the jockey for new money, this proposal “stands a better shot than most.”
The antibiotics initiative will part of Obama’s budget request, to be fully unveiled on 2 February, for the 2016 fiscal year, which begins in October.
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