More On Court Ordering FDA Hearings on Farm Antibiotics

Since I posted last night on the judge’s order that the Food and Drug Administration examine the safety of farm antibiotics — via hearings that the Food and Drug Administration scheduled, but never held, back in 1977 — a lot has happened. Here’s a round-up.

The Natural Resources Defense Council, lead plaintiffs in the suit (with the Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen and Union of Concerned Scientists) has put up a press release/explainer, accompanied by a blog post written by lead attorney Avinash Kar.  (Correction: The lead attorney is Jen Sorenson.) Key quote from Kar:

The judge’s opinion makes it clear that FDA’s voluntary approach—letting the industry police itself—does not satisfy its legal obligations. FDA must schedule hearings to let drug manufacturers make their case, and if the drug manufacturers cannot prove that the use of antibiotics in animal feed is safe, FDA must withdraw approval for those drug uses.

Kar’s comment to me: “We think this is a great step forward for public health. For 35 years, FDA has basically sat on the sidelines, mostly letting the industry police itself. In that time we have seen a massive rise in the occurrence of antibiotic-resistant bacteria. This means we now will ensure that we preserve these lifesaving medicines for those who need them most.”

I asked the press office this morning at the Center for Veterinary Medicine, the FDA division named in the order, if the agency has a response yet. They said: “We are studying the opinion and considering appropriate next steps.”

The opinion/order is posted in PACER, the US Courts’ electronic document system. It’s free, but you have to register and be issued a password, so I’ve put a copy up at my Scribd account. It is long — 55 pages — but provides an excellent summary of the complex history of this issue at FDA. (For a quicker timeline, go here.)

Other reactions:

Co-plaintiffs CSPI, Food Animal Concerns Trust, Public Citizen and Union of Concerned Scientists all have released statements (UCS seems to be the only group to have put theirs online), and so has the umbrella group Keep Antibiotics Working. KAW links the decision to trade competitiveness; recall that Europe banned growth promoters years ago: “When these drugs are moved from the market, U.S. livestock agriculture will move into the 21st century, shifting American agriculture more in line with our trading partners and trade competitors.

Rep. Louise Slaughter, a public-health microbiologist and sponsor of PAMTA, legislation that would restrict agricultural use of antibiotics that are critical in human medicine, said in a statement:

The FDA has been dragging its feet on this for 35 years. We’ve all known that this is a public health issue for quite some time. Of course if an animal is sick, it should be treated. But the evidence for ending the daily dosing of antibiotics to otherwise healthy animals is overwhelming.

The pieces are still falling into place on this, but it seems to me there are some big questions looming.

What happens next, just practically speaking? The last page of the order notes that NRDC and the other plaintiffs, and FDA, have agreed to further talks regarding establishing a timeline for any administrative hearings to be held by FDA. In addition, the suit had an entire second component, regarding citizens’ petitions to the FDA on farm antibiotics, for which there are court arguments still scheduled.

What happens to the FDA’s long-delayed guidance to industry, known in shorthand as Guidance 209, which is supposed to address voluntarily restricting use of growth promoters/feed-efficiency drugs? That guidance was published in draft form in June 2010 and people working on the issue had been hearing rumors it might be finalized soon.

Finally, if hearings are scheduled, what evidence can the pharmaceutical industry bring regarding the safety of growth-promoter antibiotic use? That was what FDA called for back in 1977, when these hearings were first proposed. But since then, there have been at least hundreds and maybe thousands of pieces of research into this question — and a good portion of the evidence, though not all, supports the contention that growth promoter antibiotic use encourages the evolution of antibiotic-resistant bacteria that move off the farm to create antibiotic-resistant illness elsewhere. (Support for that guesstimate: When I search in the National Library of Medicine’s PubMed search engine, “growth promoters + antibiotic resistance” returns 174 hits; “antibiotics + resistance + animals” returns 15,641; so the true size of the research literature is somewhere between those two numbers.)

Once again, more to come.



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