Sen. Elizabeth Warren Takes FDA Chief To Task On Weak Antibiotics Guidance

warrengrabIn December, the Food and Drug Administration showed just how little it actually cares about drugs in our food by — after more than 35 years of dragging its feet on the topic — politely asking drug companies to pretty please stop selling medically unnecessary antibiotics to farmers who put the drugs in animal feed solely to encourage muscle tissue growth. Today, Senator Elizabeth Warren had the chance to grill FDA Commissioner Margaret Hamburg on the topic, and she didn’t pull her punches.

Appearing before the Senate Committee on Health, Education, Labor & Pensions (HELP), on Thursday, the questioning of Hamburg got off to a good start with Sen. Warren of Massachusetts citing the recent CDC study which found that more than 2 million Americans get sick with antibiotic-resistant infections every year, and research showing that antibiotics fed to animals for non-medical purposes are only serving to create new drug-resistant superbugs.

“If we continue to use 30 million pounds of antibiotics in food animals every year — which is about four times as much as we use in people — we’re likely to have a lot more resistant infections, and fewer antibiotics that work when we need them,” said the Senator.

The December guidance from the FDA asked drug makers to change the labels on animal antibiotics to reflect that they are intended for only medical uses. As numerous critics have pointed out, this only removes a very small number of drugs from the market, and really just forces farmers to claim that the reason for purchasing the antibiotics is “disease prevention.”

And that’s exactly what the Senator wanted to know about at today’s hearing.

“Surely the removal of production uses is a good first step, and I’m hopeful that this is going to lead to decreasing use of antibiotics,” continued Warren. “But the FDA’s guidance doesn’t guarantee the prudent use of antibiotics in the context of disease prevention. Even with every animal drug company agreeing to comply with the FDA’s most recent guidance, there could still be a lot of antibiotic use in animals that is ostensibly for disease prevention but is still far more than necessary and will continue increasing resistance.”

She asked Commissioner Hamburg, “How will this guidance and the FDA’s review of labeling changes ensure that we’re reducing the antibiotics’ use in agriculture and decreasing the risks of perpetuating resistance?”

In response, Hamburg claimed, “I think [the steps being taken by the FDA] will make a real and enduring difference.”

Well, that’s all well and good, but what about the question?

“We’re going to be moving the oversight of the use of these products to the supervision of a veterinarian, which isn’t the case now,” answered the Commissioner. “So it will be much more like you’re familiar with — with a prescription from a doctor and the release of a drug; the same will be true of veterinary oversight of the use of these products for the preventive and treatment purposes.”

Hamburg continued, “Of course, there will always be a need for antibiotics to treat animals for important illnesses they may have and also there is a role for prevention, but we want to make sure that it’s appropriate and adequately supervised, and especially when they are antibiotics of importance for human medical needs as well.”

The response didn’t seem to win over the Senator, who deemed the current guidance a “very good first step,” but pointed out that “veterinarians are permitted to prescribe for anything that’s on-label use. And so long as they are permitted to use it effectively for preventive disease that means there’s the possibility of just continuing to keep these drugs out in circulation, keeping them out there all the time, even with the approval of a veterinarian.”

Unfortunately, that’s when Sen. Warren’s time expired, meaning the rest of her questions will need to be answered in a less-public forum.

Regardless, it was a much-needed sign from someone on Capitol Hill that, no matter how much big pharma and big farm love the weak-kneed guidance, there are those who see past the lipstick on this pig.

After today’s hearing, the folks at Keep Antibiotics Working — a coalition of health, consumer, agricultural, environmental, animal welfare, and other advocacy groups — applauded the Senator’s questioning of Commissioner Hamburg.

“Keep Antibiotics Working thanks Senator Warren for holding FDA accountable for its policy,” reads a KAW statement. “Commissioner Hamburg’s statement that increased veterinary oversight through the use of veterinary feed directives will address concerns about overuse in animal feeding operations is troubling. First, many veterinarians do not accept that antibiotic use in food animals contributes to a human health risk, so they cannot be relied upon to reign in overuse. Second, FDA is proposing to remove the bulk of protections built into existing rules for how drugs requiring veterinary oversight in feed can be used.”