At issue is inappropriate or overuse of antibiotics, which advocates argue is contributing to a public health crisis. They contend the FDA should increase its oversight, which last summer several US Senators complained has been lacking. But the groups also maintain the FDA needs additional authority from Congress in order to better monitor antibiotic usage and collect applicable data.
"We'd like to see the FDA given more authority to collect and report on antibiotics that are given animals that are used for food," says Laura Rogers, a project manager at Pew Charitable Trusts, one of several groups that wrote the US Senate Committee on Health, Education, Labor and Pensions urging action. "The FDA has settled for data on high-level use of drugs by class rather than more detailed reporting. It's been 2-1/2 years since they've reported any robust data."
"Given that we're in a huge public health crisis with antibiotic resistance, the agency does need a nudge to do a better job, but also more authority to report on use of antibiotics by animal species. We know there are 30 million pounds of drugs used in production but how much is going to chicken, turkeys, cows and pigs, and why? That would allow us to work with other agencies to develop pilot programs for alternatives" to antibiotics.
In their letter this week to the Senate HELP committee, the groups argue the Animal Drug User Fee Act, which has a September 20 reauthorization date, should not be renewed unless the legislation improves existing requirements for collecting and reporting antibiotic sales data, and requires the FDA to track and publicly report how drugmakers respond to its voluntary program, so that Congress can evaluate the effects on antibiotic usage (here is the letter and further details).
Toward that end, two members of Congress yesterday introduced the Delivering Antimicrobial Transparency in Animals Act, which would require drugmakers to obtain and provide better information to the FDA on how their drugs are used in food-producing animals. The bill would also require producers of poultry, livestock and swine to report data on the use of medications given their livestock (here is a summary).
"Right now, 80 percent of all antibiotics used in the United States are used not on humans but on food-animals, many of whom are already perfectly healthy," says Louise Slaughter, a New York Democrat who co-sponsored the DATA Act. "As a result, antibiotic-resistant bacteria now kill more Americans every year than HIV/AIDS." The other co-sponsor is Henry Waxman, a Democrat from California.
At times, however, the FDA has allegedly made it more difficult to comprehend the extent of the problem. Two months ago, the Government Accountability Project, one of the groups that wrote the Senate HELP committee, filed a lawsuit against the FDA for refusing to disclose data about the sale of antibiotics that are sold for use in animals that are used to produce food (back story).
As we reported previously, last April, the FDA issued guidances that were designed to tighten the use of antibiotics in food-producing animals. As part of its plan, the agency hoped to convince drugmakers to voluntarily curtail “injudicious” use – specifically, labeling changes were sought so that antibiotics are not used for production purposes. And three drugmakers – Eli Lilly (LLY), Pfizer (PFE) and Merck (MRK) – subsequently agreed to do so.
In its reports, the FDA also recommended that farmers obtain prescriptions to get antibiotics for their livestock and antibiotics should only be given when medically necessary to avoid overuse that can create resistance. But several senators complained the FDA initiative has fallen short and asked the agency to increase oversight of antibiotics and eliminate any antibiotic use for promoting animal growth (back story).
“There is considerable ambiguity about the actual impact of this guidance,” the senators wrote. “If broadly defined, disease prevention could allow the continued use of antibiotics in ways not consistent with the FDA’s vision for ‘judicious use.’ This could include inappropriate and ineffective practices that merely mask underlying production problems such as poor hygiene or animal overcrowding.”
Unfortunately, says Rogers, the FDA has not issued a timetable for regulation and adds that "it would be helpful if some of the big drugmakers came forward with more data. I have to believe they know, for the most part, how their drugs are being used and that could help fill in the picture." And she adds that food producers, such as Tyson and Cargill, could also provide data. "In the absence of that, I think Congress has a huge opportunity right now with the authorization" of the user fee act.
cow pic thx to dave hogg on flickr