Two Former FDA Commissioners Agree: Ag Antibiotic Policies Must Change

This is an ICYMI ("in case you missed it") post, twice over. Last week, former Food and Drug Administration Commissioner Donald Kennedy, Ph.D., wrote a piece for the Washington Post in which he urged that the FDA change how it regulates antibiotics that are used in agriculture as part of meat production.

His prescription is notable, not just in itself, but because it marks the second time in a few months that a former commissioner of the FDA used a major paper's op-ed page to criticize his former agency's conduct on farm antibiotic use. David A. Kessler, M.D., did the same thing, hitting many of the same points, in the New York Times in March.

Kennedy was FDA Commissioner from 1977 to 1979, just as scrutiny of antibiotic use in livestock-raising was beginning. (There's a timeline in this post.) Kessler was Commissioner from 1990 to 1997, during the time in which the FDA began to look for, and find, antibiotic-resistant bacteria on retail meat. There were almost 20 years between their tenures -- and 16 years from Kessler to now -- and yet almost nothing has changed.

Here's Kennedy:

When I was commissioner of the U.S. Food and Drug Administration (FDA), the agency’s national advisory committee recommended in 1977 that we eliminate an agricultural practice that threatened human health. Routinely feeding low doses of antibiotics to healthy livestock, our scientific advisory committee warned, was breeding drug-resistant bacteria that could infect people. We scheduled hearings to begin the process of curtailing the use of penicillin and other antibiotics for this purpose, but Congress halted the effort before it started.

Today, the science is even clearer that antibiotic overuse in agriculture is dangerous — yet the same risks persist.

Here's Kessler:

While the F.D.A. can see what kinds of antibiotic-resistant bacteria are coming out of livestock facilities, the agency doesn’t know enough about the antibiotics that are being fed to these animals. This is a major public health problem, because giving healthy livestock these drugs breeds superbugs that can infect people. We need to know more about the use of antibiotics in the production of our meat and poultry. The results could be a matter of life and death.

In 2011, drugmakers sold nearly 30 million pounds of antibiotics for livestock — the largest amount yet recorded and about 80 percent of all reported antibiotic sales that year. The rest was for human health care. We don’t know much more except that, rather than healing sick animals, these drugs are often fed to animals at low levels to make them grow faster and to suppress diseases that arise because they live in dangerously close quarters on top of one another’s waste.

Kennedy's op-ed is a plea for finalization of what is known as Guidance 213, which is a bookend to what's known as Guidance 209. Translated from fed-speak, here's what those two documents represent. Guidance 209 is the document in which the FDA asks livestock producers to voluntarily stop using "growth-promoter" micro-doses, which make animals put on weight more quickly but lead to the emergence of resistant bacteria. Guidance 213 is the essential second piece that tells drug manufacturers how to package and label their drugs for marketing under this new voluntary scheme.

Guidance 209 has been finalized; it is federal policy. Guidance 213 has been in draft form since April 2012, with no apparent movement to finalize it in turn.

Kennedy argues this inaction is holding back change:

Agricultural businesses should be able to treat animals in ways that promote efficiency and profit, which includes giving the drugs to livestock that are actually infected. But the FDA should not allow extensive uses of antibiotics in confined animals for prophylactic protection; doing so threatens to undermine those same drugs that are critical to human medicine.

A far better solution would be to improve the crowding and poor sanitation that make food animals susceptible to disease in the first place. Action by the FDA would be the initial step to encourage companies to make such changes and stop relying on massive overuse of antibiotics.

Kessler, in his op-ed a few months ago, is less sanguine that the veterinary pharma sector is willing to change; he called for movement in Congress to compel the collection of better data than is now made available regarding agricultural antibiotic sales and use.

But he would agree, I think, with Kennedy's closing remarks:

It has been 36 years since the agency moved to restrict injudicious antibiotic practices that threatened the public’s health. It should not wait any longer to finish the job.