A group of research experts called on Congress to offer a new set of R&D incentives to spur fresh work in the development of antibiotics. And they also want the FDA to clarify regulations around antibiotic development to create a clear pathway to an approval.
Robin Robinson, director of the Biomedical Advanced Research and Development Authority at the Department of Health and Human Services characterized growing levels of antibiotic resistance as a biodefense issue. Federal incentives would go a long way to encouraging developers to work more actively in the field, he added, while advocating "dual-purpose" antibiotics which could help guard against a bioterror attack and at the same time offer new options for public health.
"The lengthy drug development process means that new classes of drugs to supplement or replace current ones are still years away at best," Robinson told the House of Representatives Committee on Energy and Commerce's Subcommittee on Health.
"Over the last decade, regulatory uncertainty, including ever-shifting FDA guidelines, have had a significant negative impact on approval of antibiotics," said Dr. Barry Eisenstein, a senior vice president at Cubist Pharmaceuticals. Eisenstein called on lawmakers to extend patent protection on antibiotics in order to encourage new research work.
- here's the article from Reuters