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Antibiotic arsenal not being restocked

We have come to expect that modern medicine can cure just about any infection. But bacteria are finding ways to evade, one by one, the drugs in our arsenal, and that arsenal is not being replenished with new antibiotics.

Drug companies are abandoning the antibacterial business, citing high development costs, low return on investment and, increasingly, a nearly decade-long stalemate with the Food and Drug Administration over how to bring new antibiotics to market.

Some doctors fear we could be defenseless against bacteria that can resist all existing antibiotics.

At the core of the problem is a regulatory impasse over whether drug companies seeking FDA approval for antibiotics should be required to run much more stringent clinical trials.

The FDA says yes, citing advances in the science of clinical trial design and a series of humiliations involving trials for drugs the agency had approved, including the antibiotic Ketek.

"We don't want to approve products that don't work," Dr. Joshua Sharfstein, principal deputy commissioner of the FDA, told physicians and scientists gathered for a workshop on antibiotics and clinical trials in late July.

But the pharmaceutical industry and some infectious-disease doctors say the proposed rules will make it so difficult and expensive to gain approval for new antibiotics that the few remaining companies will abandon the field altogether.

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