Getting More Farm Antibiotics Data: What Will It Take?

Sorry for the radio silence, constant readers: I'm preparing for the big annual conference of the Association of Health Care Journalists, where I am on the board, and the tasks are piling up. Here's one of the things that happened last week, while I was off getting ready: The Senate committee charged with oversight of agricultural antibiotic use took up re-authorization of the regulation that delivers data on ag drugs, without allowing any testimony about the negative, unintended consequences of misusing and overusing those drugs.

Fortunately, the House of Representatives provided a partial corrective: Members there introduced a bill that would require better data collection. Unfortunately, that bill is a long way from law — and the re-approval of the FDA regulation is close.

Here's some back-story: I've written before about the Animal Drug User Fee Act, known as ADUFA. The passage of ADUFA created a scheme under which veterinary-drug manufacturers surrender some data about the sales of their products in exchange for arrangements under which new drug products are approved more rapidly. The data the companies surrender represents just about everything the public gets to know about antibiotic use in agriculture, but it is not much — and more data is collected and sent to the Food and Drug Administration than the FDA releases.

ADUFA is now up for its five-year re-authorization, and advocacy groups have been pressing for the FDA to both release more of the data it gets, and ask for more data from the companies. So they were dismayed that last week, when the Senate's Health, Education, Labor and Pensions Committee took up the bill that would permit ADUFA's reauthorization, the committee heard from exactly three speakers: the chief of FDA's Center for Veterinary Medicine, and representatives of branded and generic animal drugs. (The hearing page, with full video of the hearing, is here.)

A coalition of advocacy and medical groups -- Pew Charitable Trusts, Keep Antibiotics Working, Union of Concerned Scientists; American Public Health Association, Infectious Diseases Society of America, Dignity Health (a large California health care delivery organization); and about 30 others -- protested the limits of the hearing in a letter to the HELP Committee's leadership and members. They asked the committee to increase the amount of data the FDA collects and also the amount it publishes, all with the goal of tracking and combating antibiotic resistance.

That may have been a doomed effort, though. In an analysis, Mae Wu of the Natural Resources Defense Council discloses that a constant theme in the hearing was of the need to keep a "clean" bill -- that is, one that does not have extra amendments attached to it during the process. Improving data collection on antibiotic use would be one such amendment. She says:

Senator Harkin is reported by CQ Roll Call as saying after the hearing, “There are those who might want to address issues of antibiotics on this bill. This is not the place for it. That’s why we left that off of this....That could really gum up the works if that were attempted.”

But if the Committee won’t talk about the critical problem of antibiotics in livestock at a hearing addressing animal drugs and the public health and in reference to a bill about animal drugs, then when will it talk about it?

It turns out that people are willing to talk about it -- just on the other side of the Hill. The night before the ADUFA hearing, Reps. Henry Waxman (D-California) and Louise Slaughter (D-New York) introduced a new bill intended to compel better data collection, the Delivering Antimicrobial Transparency in Animals Act. (Yes, the acronym is DATA.) In their announcement, Waxman said:

We need to learn more about how these drugs are being used. With this information, scientists will be able to better pinpoint the relationship between the routine use of antibiotics in animals and the development of dangerous resistant bugs that can harm humans. This knowledge will inform scientists and Congress and start us down the path to sensible regulation.

The legislation is an encouraging development -- though with the House under GOP control, the bill may not move any more quickly than Slaughter's several-times-introduced PAMTA (Preserving Antibiotics for Medical Treatment Act). Still, attitudes may be shifting. In the wake of the hearing and the DATA introduction, the Des Moines Register -- home paper for Sen. Tom Harkin (D-Iowa), the HELP committee's chairman -- called for a change:

At the very least, Congress should require more reporting on what drugs are being used on what animals so scientists can better track the impact on human health... Sen. Tom Harkin, chairman of the Health, Education, Labor and Pensions Committee, can ensure such data is gathered by requiring it in the Animal Drug User Fee Act, which the committee is discussing now. Longer term, American producers, who lead the world in aggressive use of antibiotics, should move toward reducing and eliminating the use of the drugs, except to directly treat disease...

It’s time for this country to care as much about protecting human health as growing big cows or chickens.

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