2016 Cures Act, FDA Reforms Could Help Streamline, Strengthen R&D Efforts To Find New Antibiotics
Wall Street Journal: The Superbug Dirty Dozen
“…[T]he superbug problem has been well understood and managed since the George W. Bush administration. CDC surveillance, physician education, and infection-control protocols have led to more prudent use of antibiotics. … Still, a study in the Journal of the American Medical Association last year estimated that almost a third of U.S. antibiotic prescriptions are unnecessary … The larger danger is that no new class of antibiotics has been introduced since 1984 and [Food and Drug Administration (FDA)] approvals since have been merely variants of old medicines. Antibiotics R&D is challenging and expensive because only a small number of patients who acquire these infections meet the conditions for traditional clinical trials. The profit motive is weak because any new antibiotic would need to be closely reserved for only the most serious new infections. Congress tried to change these incentives with the 2016 Cures Act, which increased funding for basic research and created a new antibiotic-specific FDA pathway with streamlined trials. Let’s hope these reforms — and the FDA — will allow researchers to find new antibiotics ahead of a potential 21st-century plague” (3/5).