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make more profits over the course of an antibiotic’s lifespan, which should be attractive to big companies, small companies, and venture investors who have lots of choices on where to invest.
There’s one more legislative idea making the rounds on Capitol Hill, about creating a new FDA approval pathway for certain antibiotics aimed at fighting drug-resistant “superbugs.” This idea, advanced by the Infectious Diseases Society of America, is to create a “Special Population Limited Medical Use” designation for these powerful drugs. The gist is that antibiotic developers going after certain worrisome bugs could run some basic animal tests, some small human trials suggesting effectiveness, and then get FDA approval without having to jump through more time-consuming and expensive hoops. In return for getting faster access to the market, the FDA would slap a very clear and specific label on the drug which says it should only be used in extreme cases, like when other antibiotics have already failed.
This idea strikes me as problematic, because even if the FDA writes some really tough language in its prescribing information for physicians, the FDA can’t regulate the practice of medicine, and doctors will still be free to prescribe the drugs “off-label.” And if these new antibiotics are really good, doctors will probably be inclined to use them a lot, which helps foster the development of more antibiotic resistance. If new antibiotics get overprescribed, then we’re all right back where we started, with no good answers for drug-resistant bacteria.
Talking with antibiotics entrepreneurs the past few weeks, I’ve gotten a sense that the five-year market exclusivity is what’s most interesting to them anyway. “It will make our business much more attractive to a potential partner, and much more attractive to a potential investor,” says Ron Najafi, CEO of Emeryville, CA-based NovaBay Pharmaceuticals. Dave Martin, the CEO of South San Francisco-based AvidBiotics, says that even though pharma companies have been cutting back on antibiotic work, they are interested in talking about narrowly tailored antibiotics, paired with diagnostics, that can kill specific bugs without wiping out “good” bacteria in the gut. “There is interest out there in Big Pharma in narrow-spectrum antibacterials,” Martin says.
The drug business is notoriously tough, and it’s possible this is just a down cycle in the antibiotic market, from which things will rebound. But I don’t think we can afford to wait around to see if the market will turn around in a few years. There are big risks posed to public health by these bugs, and they will get worse over time if R&D continues to be stuck in the mud.
It just makes good sense, and good public policy, to help spur antibiotic R&D. It needs to be strong and consistent—not entirely subject to the ups and downs of the market—if we’re going to stay a step ahead of bacteria that have been evolving for a billion years. If we fall behind, people could die from things we used to consider preventable.
“I want to make sure my children and grandchildren don’t have to worry about stumbling on playground and worrying about getting an infection and dying from it,” Cubist’s Bonney says. “It happened in pre-penicillin era, when people died of pretty trivial accidents.”
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