The FDA refuses to compel companies to disclose data that would be in the public’s interest related to legislation known as the Animal Drug User Fee Act (ADUFA) 0f 2003.
ADUFA legislation was passed in 2003 as a result of complaints by the veterinary-pharmaceutical industry that approvals of new drugs were taking too long.
The legislation created a “user fee,” charged to the companies, which the FDA used to increase the amount of staff it had available to scrutinize drug approvals and get them passed.
McKenna correctly equates the legislative arrangement as “regulated companies paying the salaries of their regulators.”
When ADUFA came up for re-authorization for an additional 5 years, via “ADUFA II,” public health and consumer advocacy groups pressed the FDA for manufacturers to annually report sales of veterinary drugs.
McKenna claims it’s because of this additional requirement in ADUFA II that we learned 2 years ago livestock raised in the United States received 28.8 million pounds of antibiotics per year in 2009, and 29.2 million pounds in 2010.
But McKenna says that’s all we know. The 2011 numbers have still not been released. (Here’s the FDA page where the ADUFA reports are posted.)
These single tables, which Mckenna snipped from the reports, contain all of the data released each year.
“As you can see, in each year, the FDA released only summed amounts, in kilograms, of all the drugs sold, by all the companies, for all livestock species, across all agricultural uses: growth promoters, prevention, and treatment.”
The FDA receives all this data but is not releasing it, presumably for reasons having to do with its initial ADUFA negotiations with agriculture, says McKenna.
“We know the agency gets this data because, in 2010, under pressure from Rep. Louise Slaughter (D-NY), the FDA surrendered a further analysis of the first round of ADUFA data from 2009.”
In its letter to Slaughter, the FDA itemized the 2009 total in feed, water, and injections to individual animals. But the FDA never performed that kind of analysis again.
The current ADUFA II expires in 2013, and a December 18th hearing addressed ADUFA III, which will govern FDA reporting on ag antibiotics for the next 5 years.
This year, the FDA met with industry representatives eight times. It held one public meeting for non-industry representatives in late 2011, and had another December 18th.
At that 2011 meeting, numerous health groups urged the agency to increase both what it asks from industry and what it discloses to the public. “And all of that was pretty much ignored,” says Steve Roach, the public health program director at the Food Animal Concerns Trust and a member of Keep Antibiotics Working.
In their comments, the public health and consumer advocacy groups asked first for the FDA to report out the entirety of the data that it has been receiving, but holding back, since at least 2008, and also to request additional information.
McKenna point out that a year ago, the FDA withdrew its decades-on-the-books attempt to exert regulatory control over agricultural antibiotic use, saying that it would instead pursue “voluntary” approaches to getting agriculture to reduce its vast use of antibiotics.
Consumer advocacy groups and others familiar with FDA policy knew then and now, that America’s corporate controlled agriculture sector — industrial farming — would never reasonably comply with a voluntary approach.
Antibiotic-Resistant Infections Kill more Americans than AIDS
According to the Infectious Diseases Society of America, antibiotic-resistant infections kill more Americans annually than AIDS.
In March, a federal judge ordered the FDA to withdraw approval for the use of common antibiotics in animal feed because of fears that overuse is endangering human health by creating antibiotic-resistant “superbugs”.
The federal order by Judge Katz is the result of a lawsuit filed by environmental and public-health groups, including The Natural Resources Defense Council, Center for Science in the Public Interest and the Union of Concerned Scientists.
The lawsuit argues that using common antibiotics in livestock feed has contributed to the rapid growth of antibiotic-resistant bacteria in both animals and humans.
Experts now claim the growth of antibiotic resistance poses as great a threat to global health as Aids and pandemic flu.
December 24th, 2012