An internal FDA memo circulated last month shows the agency is mulling timeframes for animal drug sponsors to comply with new voluntary policies intended to reduce the subtherapeutic use of antibiotics in food animals, but also reveals the agency has crafted regulatory options as a fallback if the voluntary efforts fail. Another internal email reveals the agency's earlier frustration with industry, with an agency official suggesting legislation or a lawsuit would be more effective than the voluntary effort. An animal drug industry source rebuffed suggestions that the documents imply industry is not on board with FDA's voluntary antibiotic control efforts.
The documents, obtained through a Freedom of Information Act Request filed by Public Employees for Environmental Responsibility (PEER), emerge as a key House lawmaker pledges to push legislation that would require industry report antibiotic use data.
PEER said the group filed the FOIA to gauge the agency's justification for its public assertions that the animal drug industry would voluntarily cooperate in limiting subtherapeutic uses of antibiotics. FDA handed over the internal emails in recent weeks after PEER sued the agency in July for not initially responding to the FOIA request, the group said.
In a May 2011 email, William Flynn, deputy director of science policy at FDA's Center for Veterinary Medicine, said the Animal Health Institute's reaction to a then-recently filed lawsuit against FDA was “very problematic.”
“They make no reference to the fact that they are working with FDA to address this issue,” he writes, responding to an AHI statement to trade press that was also sent to FDA officials. “They simply refer to the fact that the risk is 'vanishingly small' and that the products are approved by FDA and are therefore safe (i.e, there is no problem). This type of position just reinforces the idea that legislation (or perhaps a lawsuit) is needed because FDA's plan to work with industry will not work. I think we should consider reminding AHI of this point.”
The exchange occurred when the Natural Resources Defense Council and several other groups sued FDA in May 2011 for not responding to citizen petitions and not proceeding with 1977 withdrawal hearings to remove penicillins and tetracyclines from animal feed.
AHI shared its response to trade press on the the matter with FDA's top veterinary official Bernadette Dunham, who shared it with other agency veterinary officials.
“Several risk assessments measuring the risk of various antibiotic compounds used in animal agriculture have been published in peer reviewed journals, and they uniformly find the risk to public health to be vanishingly small,” according to an excerpt of the 2011 AHI statement. “In one example, the risk of a human antibiotic treatment failure due to the use of antibiotic animals was less than that of dying from a bee sting. The lawsuit not only ignores this recent science, but also fails to cite any data or new information.”
The email exchange also occurred before FDA advanced several policies on the topic. In the following months, an August 2011 internal memo shows FDA's strategy in releasing more policies aimed at restricting antibiotics, but also recognizes the strategy's limitations such as its lack of specific timeframes and questions over whether drug sponsors would decide it is in their best interest to work cooperatively with the agency and whether FDA would collect sufficient data to measure the effectiveness of the strategy.
The agency rescinded 1977 product withdrawal hearing notices in December 2011 and issued three documents in April: final guidance on the judicious use of antibiotics in food animals, proposed regulation on veterinary oversight; and draft guidance outlining how companies can voluntarily change product labels
But an animal drug industry source tells FDA Week the FOIA documents depict a narrow view on the topic and the overall the public record shows companies support and will cooperate with FDA's efforts to remove production uses from product labels.
“I think it's being taken out of context,” said Ron Phillips, vice president of legislative and public affairs at the Animal Health Institute, in response to the Flynn email.“That discussion had to do with our statement regarding the lawsuit.” Phillips further questioned whether PEER released the entire FOIA, as the group said FDA released a “foot-thick stack of materials” but the group released only 11 pages of memos and emails.
PEER says the documents clearly show the industry is not cooperating. “These documents show that FDA’s public health strategy is to whistle past the graveyard, as more people are pushed beyond the help of medically vital drugs,” said PEER Counsel Kathryn Douglass who filed the FOIA suit. “In the foot-thick stack of materials FDA surrendered there is not a shred of evidence that industry is working to phase-out injudicious use of these drugs.”
Phillips disagreed with the conclusion saying the documents do not illustrate that either party -- FDA or animal drug companies -- are not committed to the process laid out by FDA. “I cannot say that strongly enough,” he said. “FDA is obviously committed to this. We have publicly committed to this.”
Aside from the the internal emails, three memos also lay out FDA thoughts on the voluntary process.
A memo sent last month suggests FDA outline timeframes for drug sponsor action, with the agency saying the timelines would ensure the voluntary effort is making progress and companies marketing similar products are being treated equally. When commenting on the new policies, AHI and other stakeholders questioned how FDA would ensure product label changes are done in a timely manner across product classes.
“Recognizing, however, that the voluntary approach will only work if all sponsors decide it is in their best interest to work cooperatively with the agency to achieve these goals, CVM also suggests that setting out some timeframes within which we expect to see progress toward achieving these goals,” the memo states. “These could include dates by which the sponsor: submits a letter of intent to us about how/when sponsor will remove subtherapeutic claims and change marketing status; submits supplemental application to us; notifies distributors/veterinarians about change in claims and marketing status; etc.”
The agency goes on to say the timeframes will be published in the Federal Register to “help maintain a transparent process, and will assure the public that we are making real-time progress toward our final goals. It will also help assure each company that FDA is treating all companies marketing similar products similarly.”
FDA also said the agency should further evaluate how to communicate the ramifications for missing a milestone date, how far FDA should go in “foreshadowing” regulatory action if the voluntary approach fails and regulatory actions that should be taken if the voluntary action does not achieve its intended goals. The agency's email goes on to outline available regulatory actions, but they are redacted from the document released to PEER.
Phillips noted that FDA had already outlined a broader timeline for compliance when it issued guidance on the process for implementing label changes. He said he was not surprised FDA further evaluated the matter. Within three months of the guidance's finalization, FDA requests companies notify the agency of their intentions. Within three years the agency will evaluate the approach to determine whether further action is warranted, according to the draft guide.