FDA seeks to reassure US antibiotics makers

The US Food and Drug Administration has sought to reassure drugmakersthat its plans to update its approval guidelines on clearing new antibiotics will not seek to make them harder. A public meeting on the proposals will be held in January.

Sandra Kweder, the FDA's head of drug review data, said: "we are not saying we are going to change the rules so products have to be better than what's out there on the market," and that the aim of the update is simply to ensure that the agency's testing requirements are appropriate for each infection, reports the Associated Press.

Bayer's Cipro (ciprofloxacin) won its anthrax indication because of a scientifically-rigorous study in monkeys and a database of 60 million users showing its side effects in treating other infections, she said. While it would be much tougher for some other, newer drugs without that level of safety experience, the agency is working with companies on what kinds of studies could be done, she added.