Obama administration wants to loosen antibiotic approvals

Preventing infection
A nurse at a Miami hospital washes his hands while attending to patients. The hospital has strict policies in place to ensure that the staff uses procedures in the fight against resistant staph infections.
Photo by Joe Raedle/Getty Images

What do you do when bugs are outwitting drugs? That's the situation the medical community is facing with antibiotics.

Largely due to antibiotic overuse, many of the drugs that used to cure infections simply don't work anymore. And many health experts say the problem is compounded by an FDA that's too slow and unwilling to approve new antibiotics.

The necessity to develop more antibiotics that are effective against drug-resistant germs is so pressing that there's a proposal to streamline the testing and approval process.

From NPR:

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To counter the growing trend, the Obama administration is moving on many fronts to speed the development of new antibiotics.

It's investing tens of millions in private drug companies to foster new germ-killing drugs. It's setting up a new research network to develop new antibiotics. And, most controversially, federal health officials are pushing to loosen up the approval process for new antibiotics targeted at patients with life-threatening infections and dwindling treatment options.

"Where we're talking about life-threatening illnesses, you can do much less study and get those drugs out there — if in fact they'll be limited to those kinds of uses," Dr. Janet Woodcock, the chief drug official at the Food and Drug Administration, tells Shots.

In hospitals across the country, doctors are getting desperate as they try to save patients who end up dying due to infections that used to be curable with standard antibiotics.

From the New York Times:

Doctors, faced with dwindling options and little time to decide, are often left with agonizing choices over how to save a patient's life. For example, some doctors, in extreme cases, are again using Colistin, an older antibiotic that was largely abandoned years ago because of the damage it can cause the kidneys.

"A drug like Colistin would not be developed today because it is too toxic," said Dr. Helen W. Boucher, an infectious disease expert at Tufts University in Boston.


FDA under pressure to relax drug rules
"The number of FDA approvals of new antibiotics has dropped even as multi-drug-resistant strains of bacteria have proliferated. FDA advisers at last week's meeting did recommend approval of telavancin (Vibativ) — a derivative of vanco¬mycin — for the treatment of hospital-acquired pneumonia when alternative drugs are not suitable." (Nature)

Steps set for livestock antibiotic ban
"Antibiotics were the wonder drugs of the 20th century, and their initial uses in humans and animals were indiscriminate, experts say. Farmers were impressed by the effects of penicillin and tetracycline on the robustness of cattle, chickens and pigs, and added the drugs to feed and water, with no prescriptions or sign of sickness in the animals." (New York Times)

Scientists race to stop the spread of deadly superbugs
In March, "the Center for Disease Control released new evidence showing that drug-resistant bacteria are on the rise in U.S. hospitals. Although the numbers are still quite low, many officials warn that the implications of the data may be huge. Four percent of hospitals saw at least one of these cases in the first six months of 2012, up from 1 percent of hospitals in 2002." (The Daily Circuit)