Critics Resist FDA's Drug Plan

The Food and Drug Administration's (FDA's) draft plan to focus on antibiotic resistance in animal antibiotic approvals has gained few supporters.

A growing chorus of industry leaders is questioning the wisdom of the FDA's draft guidance document to assess the safety of antimicrobials used in farm animals.

It's agreed that a stringent regulatory process is needed to ensure products undergo sufficient scrutiny before approval, and consumers are assured of a safe food supply, according to the Animal Health Institute (AHI), a trade group representing animal drug makers.

Plan Needs Work

The Sept. 12 FDA proposal's lack of science and excessive estimates of risk have critics balking at doing more research without added assurance of product approvals.

Still, FDA, not Congress, is the proper place to consider antibiotic resistance, says Richard Carnevale, DVM, vice president of Regulatory, Scientific and International Affairs for AHI. FDA's risk assessment approach is superior to the proposed Congressional bans on antibiotic use in farm animals, he said during the Oct. 2 public meeting on the FDA plan.

Declares Carnevale: “Calls for comprehensive bans on whole classes of products, unless sponsors can somehow generate data to absolutely prove a negative, without specific evidence that these products are a risk to human health, is clearly not consistent with existing laws and undermines the agency's responsibility to direct its resources to those areas that might present the greatest public health impact.”

Notes Dennis Erpelding, manager of Government Relations, Public Affairs and Communications for Elanco Animal Health: “From an industry standpoint, we need to recognize the valid concerns about antibiotic resistance, whether it is at the production level or all the way through to the consumer level. But it is also very important that you have the science drive the decisions and retain the ability to utilize these antibiotic products for disease treatment, control, prevention and health maintenance.”

Carnevale commended the FDA proposal for approaching the issue on the basis of risk assessment. But AHI says the plan completely overestimates the risk of many compounds and uses.

AHI blasted the federal agency's assessment of the relevance between treating human and animal diseases, calling it a “serious disconnect…that will have the effect of clearly biasing the assessment in favor of deciding that more animal use of antimicrobials present a high risk to human health.”

Evaluating product approvals that way will “dramatically raise the hurdle of bringing a new antibiotic to the market and will also impact FDA's review of existing antibiotics on the market,” adds Erpelding.

To start with, Carnevale advises FDA to redo rankings based on evidence of risk and not speculation. “Only those antimicrobials used in the treatment of a foodborne infection should be classified as of high importance relative to animal uses.”

Also, the high degree of subjectivity found throughout the guidance document and the lack of science in ranking antimicrobials in terms of their importance to human medicine stand out as major concerns, says Tom Burkgren, DVM, executive director, American Association of Swine Veterinarians.

That ranking process is especially concerning because it seems based on arbitrary information, says Paul Sundberg, DVM, National Pork Board.

In short, FDA appears to be attempting to regulate the practice of veterinary medicine by proposing to severely limit how antimicrobials are used on farms, says Burkgren.

Producers Urge Reform

Past National Pork Producers Council President Barbara Determan testified FDA should issue a modified guidance document based on sound scientific practices that offers producers the flexibility they need to treat livestock for disease.

She says the FDA draft, which is not a formal rule, would severely restrict antibiotics and cause some unintended economic consequences.

“On today's farms, without being able to group medicate, it is simply too costly and not physically feasible to individually administer antibiotics, that under the proposed guidance, will be approved for use,” states Determan.

She cites her family's Early, IA, hog farm as a case in point. The 300 sows they purchased for the breeding herd broke with a new strain of influenza. Production dropped by 50% and they were in serious jeopardy of losing the sow herd and a $100,000 investment.

The best course of treatment proved to be extra-label use of medications, which apparently wouldn't be permitted under FDA's proposed guidelines.

Altona, IL, pork producer Jill Appell chairs the National Pork Board's Pork Safety Committee. She and her family finish about 7,000 pigs, purchasing 14- to 17-day-old weaned pigs.

A while back, some newly weaned pigs came down with Streptococcus suis infection in their joints. When this happens, pigs are often so sick they don't want to eat and drink so they are injected with penicillin. This is an extra-label use for this antibiotic, approved by her veterinarian, she says.

In her testimony, she also noted that water and feed medications provide an efficient means of delivering medication to a large group of at-risk animals. If these antibiotics are not routinely available, it will be not only an animal welfare problem, but also an environmental problem disposing of the dead pigs, she states.

Declares Sundberg: “We do not now have an adequate arsenal of antimicrobials to address the health needs of our animals. It is often through extra-label use that is directed by the veterinarian using his or her professional judgment and knowledge that we are able to maintain our animals' health and the safety of the food supply.”

Submit comments until Nov. 27 on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The full text is online at

Challenging ‘Freedom of Choice’

Producer “freedom of choice” to use antibiotics in animals is being challenged by several opposition groups who tout better environment and management as keys to solving animal disease problems.

These activists believe that a redesign of U.S. animal production systems will help avoid disease problems, says Annamaria Castiglia, DVM, Phibro Animal Health.

But a ban on antibiotics and a redesign of facilities in Denmark failed to curb problems. In fact, animal disease problems escalated (see story, p. 16), and food-borne illnesses are 3-5 times higher than in the U.S., she says.

When surveyed by the International Food Information Council, European consumers indicated their highest concern regarding food is its safety.

These activist groups include: Keep Antibiotics Working (KAW); Center for Science in the Public Interest; Environmental Defense; Global Resource Action Center for the Environment; Humane Society of the United States; Institute for Agriculture and Trade Policy; National Catholic Rural Life Conference; Natural Resources Defense Council; Physicians for Social Responsibility; Sierra Club; and Union of Concerned Scientists.

Consumer Views on Antibiotics

How do consumers feel about antibiotics fed to livestock?

Elanco Animal Health, in cooperation with the Animal Health Institute (AHI), conducted a nine-country consumer focus group project to find out.

Unaided, consumers were asked for their opinions on food safety and animal production. Antibiotic use did not come up, says Elanco's Dennis Erpelding.

Aided or prompted by a discussion about antibiotics, moderators learned consumers have a general lack of understanding on the subject.

When asked what they'd like to know, first was how antibiotics are used and regulated. Next they wanted to know what steps are being taken to ensure food safety in the U.S.

Erpelding says the key message points regarding various means of assuring food safety include: quality assurance programs, antibiotic prudent use programs and consumer educational programs on proper cooking and handling of meat products.

“We are working through our trade association but also are willing to work with individual companies to talk about antibiotic uses, regulations and frequently asked questions by consumers,” says Erpelding.

The goal is to have more fact-based decisions rather than perception-based decisions, he says. In that regard, a list of frequently asked questions about antibiotic use in animals has been developed. That can be found at