FDA Sued for Withholding Data on Antibiotic Use in Food Animals

If you live in the United States and want to get involved on a national level, Food Democracy Now! has created a petition against the overuse of antibiotics in livestock production. If you care about this issue, I suggest you use this petition to make your voice heard.

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By Dr. Mercola

The United States uses nearly 30 million pounds of antibiotics annually in food production. Livestock antibiotic use accounts for 80 percent of the total antibiotics sold in the US, and unnecessary use of antibiotics in food animals (cows, pigs, chickens, and turkeys) is a major driving force behind the rampant development of antibiotic-resistant bacteria.

Compare this to the 6 million pounds of antibiotics that are used for every man, woman and child in the US combined. But unlike human use, in which antibiotics are prescribed to treat serious infection, in animals, drugs such as penicillins and tetracyclines are routinely added to animal feed as a cheap way to make the animals grow faster.

The primary reason why concentrated animal feedlot operations (CAFOs) are such hotbeds for breeding antibiotic-resistant bacteria is because of the continuous feeding of low doses of antibiotics to the animals, which allows pathogens to survive, adapt, and eventually, thrive.

In short, American food producers are trading slightly reduced production costs (i.e. more meat per animal) for more lethal illnesses — both in animals and humans. Just one of several now resistant pathogens, Methicillin Resistant Staphylococcus Aureus (MRSA), is responsible for more than 94,000 infections and 18,000 deaths in the US each year!

Food Producers Now Responsible for Rapid Increase in Lethal Diseases

To combat the dramatic rise in antibiotic-resistant disease, the most important step is to curb the misuse of antibiotics in food production. Sure, we need to start prescribing antibiotics more judiciously in the medical setting as well, but when you consider that medical use of antibiotics accounts for just 20 percent of all the antibiotics sold each year, it makes sense to restrict the primary culprit the hardest, or else we'll never make a dent in this problem.

Alas, the US Food and Drug Administration (FDA) has continually fallen short in this regard. Instead of enforcing stricter regulations, the agency has simply asked food producers to voluntarily limit their use of certain antibiotics. In fact, on December 22, 2011, the agency quietly posted a notice in the Federal Register1 that it was effectively reneging on its plan to reduce the use of antibiotics in agricultural animal feed – a plan it has been touting since 1977!

According to the Federal Register:

"The Food and Drug Administration (FDA or the Agency) is withdrawing two 1977 notices of opportunity for a hearing (NOOH), which proposed to withdraw certain approved uses of penicillin and tetracyclines intended for use in feeds for food-producing animals based in part on microbial food safety concerns."

FDA Sued for Withholding Drug Data

But that's not all. The FDA now stands accused of wrongfully withholding data regarding the sale of antibiotics for use in food animals — a move that makes it virtually impossible to evaluate the extent to which these drugs are causing harm. On December 5, the Government Accountability Project (GAP) filed a lawsuit against the FDA after the agency refused to release data on the amount of antibiotics sold for use in food animals in 2009.

According to the featured report by foodwhistleblower.org2:

"Drug companies are required to report basic information about antibiotic sales to the FDA under the Animal Drug User Fee Act (ADUFA). Such information includes how much of each drug is sold; whether the drugs are formulated for use in feed, water, or by injection; and the animals for which each drug is approved. FDA publicly releases a limited summary of ADUFA data each year, but withholds almost all of what companies report.

This lawsuit comes after FDA's failure to respond properly to GAP's Freedom of Information Act (FOIA) request to the agency, which sought data concerning the amount of antibiotics sold for use in food animals in 2009, classified by animal type and dosage information.

The Johns Hopkins Center for a Livable Future (CLF), an academic research center based at the Johns Hopkins Bloomberg School of Public Health, approached GAP for help obtaining these data almost two years ago. GAP made the request in February 2011, and has exhausted all other steps to get the information, short of litigation. In the end, the agency denied GAP's request, claiming that the requested data is "confidential commercial information."

That's just not good enough, according to GAP Food Integrity Campaign Director Amanda Hitt, who pointed out that "the agency's job is to protect the public's health, not industry secrets." As usual, there's also the issue of financial conflicts of interest at work. According to Tyler Smith, Senior Research and Policy Associate with the Johns Hopkins Center for a Livable Future (CLF)3:

"Why is FDA so lethargic? Its inaction appears to result from a major conflict of interest centered on ADUFA. The main purpose of this law is to collect millions of dollars in "user fees" from drug companies to speed review and approval of applications for new animal drugs submitted by drug companies. The agency collected $18 million under ADUFA last year.

ADUFA will expire next year unless Congress reauthorizes it. FDA is desperate for industry support for reauthorization — without ADUFA, the agency clearly would lose a great deal of money... FDA will not bite the hand that feeds it by enhancing ADUFA's reporting requirements. Indeed, in recommendations to Congress on how ADUFA should be amended when it's reauthorized, the agency did not even mention the requirements. FDA just swept them under the rug."

What is the Government Accountability Project (GAP)?

The Government Accountability Project4 (GAP) is a non-partisan, non-profit public interest group that works to empower citizen activists and to protect whistleblowers by promoting corporate and government accountability. Some of the group's areas of interest include monitoring drug safety, environmental agencies, government affairs and food integrity, and acting as a watchdog over national security and human rights, international reform, legislative issues, and public health5.

GAP also is a founding member of the Safe Food Coalition, which works closely with Congress and food safety agencies to ensure the integrity of our food supply.

According to GAP's website, numerous whistleblowers and clients have risked their careers to help the organization pursue extraordinary projects that have resulted in legislative changes and/or lawsuits. It does all this with a $2.5 million a year budget, with funds coming from more than 10,000 individual donors and foundations, legal fees, settlement awards, and services provided. Some of its donors include the Carnegie Foundation, CS Fund, Ford Foundation, the Open Society Institute, and Rockefeller Family Fund.

New Legislation Seeks to End the Secrecy on Livestock Drug Use

In related news, on October 16, California Representative Henry Waxman, ranking member of the Energy and Commerce Committee, announced he is introducing legislation6 to "increase information on the amount and use of antibiotics in animals raised for human consumption."

The bill, "Delivering Antibiotic Transparency in Animals (DATA) Act," would require drug manufacturers to issue comprehensive reports to the FDA on how their drugs are actually used. It would also for the first time require feed mills to report how they use the drugs. Data reporting would include the types, purposes and quantities of antibiotics being added to animal feed.

"We need this information so scientists and Congress can stop the spread of drug-resistant infections from farm animals to humans," Waxman said at a Santa Monica press conference.

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