The President’s Council of Advisors on Science and Technology (PCAST) will meet Friday to discuss its work on antibiotic resistance and nanotechnology and to hear from speakers about oceans policy.
A group of public health, consumer, and environmental protection organizations have sent a letter to PCAST expressing concern that the U.S. Food and Drug Administration’s Guidance for Industry #213 and a proposed Veterinary Feed Directive (VFD) rule do not go far enough in addressing antibiotic overuse on farms.
By March, FDA had heard from 25 of the 26 drug manufacturers affected by Guidance #213 that they would comply. In a six-month progress report issued last week, the agency announced that the final sponsor has also confirmed its engagement.
The letter to PCAST reiterates the criticism that the focus on removing growth promotion from labels will still allow for overuse under the guise of “disease prevention.”
And a recent letter to FDA from Keep Antibiotics Working noted that companies might still continue extra-label marketing for growth promotion and other benefits.
“Another key policy flaw is the proposed removal from the existing VFD regulations of a federal valid veterinary-client-patient relationship (VCPR) standard,” reads the PCAST letter. “FDA has stated that one of the goals of the revision is to end over-the-counter use in feed, but there is no clear substitute in federal or state law that ensures on-farm veterinary engagement regarding antibiotic use in animal feed.”
The list of more than 20 signatories includes the American Academy of Pediatrics, the Center for Foodborne Illness Research and Prevention, the Center for Science in the Public Interest, the Consumers Union, the Environmental Working Group, Food and Water Watch, the Johns Hopkins Center for a Livable Future, Keep Antibiotics Working, the Natural Resources Defense Council and the Pew Charitable Trusts.
The groups are calling for PCAST to recommend restoring the CVPR standard and “additional policy measures that would rein in all indiscriminate, untargeted, and unnecessary antibiotic use in meat and poultry production.”
Laura Rogers, director of Pew’s campaign on human health and industrial farming, told Food Safety News that the groups were worried that PCAST seemed uncertain as to how to proceed after its initial meeting regarding antibiotics in April.
The committee was trying to ascertain just how much agriculture usage contributes to the antibiotic resistance problem in humans, but this is a very difficult question to answer because of lack of pertinent data.
Pew and many others await PCAST’s report on antimicrobial resistance. It won’t be issued before Friday, but it could come soon after.
“Our worry is that because it’s the animal side and they were asking questions like, ‘What’s the biggest contributor?,’ that they’re going to cordon off this issue and set it aside and just focus on human medicine and the need for spurring innovation of new drugs,” Rogers said.
She added that Salmonella antibiotic resistance data released by the National Antimicrobial Resistance Monitoring System (NARMS) last week illustrates the need for more granular-level data to figure out how to stop creating superbugs.
In early May, the World Health Organization (WHO) released a global report finding that surveillance of antibiotic resistance is generally “neither coordinated nor harmonized, compromising the ability to assess and monitor the situation.”
“I can’t imagine a [PCAST] report that would come out that wouldn’t address the need for better surveillance both in human medicine — how we’re using them and why — and on the animal side,” Rogers said. “We have enough data to act, but we need more information to know the strategic ways we can go in and cut out broad overuses of the drugs.”
The U.S. is “woefully behind much of the rest of the world,” especially Europe, in terms of confronting antibiotics overuse, Rogers added.
France recently published an assessment of the risks of emerging antimicrobial resistance related to patterns of antibiotic use in animal health, following the government’s decision to reduce the use of antibiotics in veterinary medicine over the 2012-2017 period (the Ecoantibio 2017 plan).
Sweden has challenged the European Union to match its own livestock welfare standards, which include medicating animals only when they are ill.
On June 25, the Netherlands hosted an international conference on antibiotic resistance as a follow-up to the WHO report. During her address, the Dutch Minister of Health, Welfare and Sport, Edith Schippers, said that, “When it comes to agriculture — it is my firm belief that we should ban the use of our last-resort antibiotics in animal husbandry all together.”
And, on July 1, U.K. Prime Minister David Cameron announced the creation of a new review panel that will investigate antibiotic overuse generally and why new drugs are not being developed.
“To my knowledge, no one with an equivalent position in the US government has ever spoken so directly or substantially about antibiotic resistance — and particularly not about the politically contentious (though scientifically settled) problem of drug use in agriculture,” wrote Maryn McKenna in her Wired blog post about Schippers and Cameron. “Imagine Obama speaking out about antibiotic resistance. What a powerful statement of priorities that would be.”
Although the PCAST report on its own will not be able to compel FDA action, Rogers said she hopes it will prompt the Obama administration to follow with an action plan on how to address the issue.
“FDA has taken this step [with Guidance #213], but the agency is just moving at a pace that is not equal to the public health crisis that we’re facing when it comes to antibiotic resistance,” she said. “Hopefully, the report will add some fire to getting the agency to move more quickly.”