Story URL: http://news.medill.northwestern.edu/chicago/news.aspx?id=229426
Story Retrieval Date: 4/17/2015 11:15:58 AM CST
Will pharmaceutical companies help remove antibiotics from animal feed voluntarily? We’ll soon find out.
The three-month period allotted by the Food and Drug Administration to pharmaceutical companies to reveal whether they would voluntarily change product labels for medically important antibiotics ended Wednesday. The deadline marks the close of the first phase of the implementation of guidance for industry 213, published by the agency in December.
The guidance seeks to stop the use of medically important antibiotics for food-animal growth enhancement. Medically important antibiotics are those used for treating humans.
Limiting the use of these antibiotics in feed and supplements for livestock will hopefully slow the spread of antibiotic resistance in humans, according to the FDA. Antibiotic resistant bacteria are responsible for the death of 23,000 Americans every year, based on estimates from the Centers for Disease Control and Prevention.
The FDA has requested that pharmaceutical companies voluntarily remove growth applications from their product labels and cease marketing medically important antibiotics as over the counter supplements.
In a statement released Thursday, the agency offered an update on the process.
“As of March 12, 2014, FDA has received responses from all of the [drug] sponsors affected by this guidance and is currently reviewing and analyzing those responses. We are encouraged by the positive response thus far.”
According to an email exchange with FDA spokeswoman Megan Bensette earlier this year, “FDA intends to publish summary information to provide an indicator of the level of engagement of affected drug sponsors in the voluntary process.”
The FDA has yet to release a detailed update on which pharmaceutical companies have complied with the guidance but stated that they would do so later this month.
Some pharmaceutical companies have already expressed their support, including Elanco and Zoetis, the world’s largest animal health company.
Scientists don’t yet know exactly how antibiotic resistance spreads from animals to humans, but repeatedly exposing animals to low-dose antibiotics for the purposes of helping them grow faster has been shown to increase the rate of antibiotic resistance in humans as well as animals.
However, it is important to note the difference between antibiotic-resistant bacteria found in the meat we eat and antibiotics found in the meat we eat. By law, food producers must make sure that antibiotics are fully metabolized and flushed from the meat we eat before the meat is processed, or they face large fines. Most meat purchased by consumers in the grocery store does have bacteria and even antibiotic-resistant bacteria on it but it is killed when the meat is cooked thoroughly.
Many advocacy groups have voiced disappointment with the voluntary proposed FDA policy but according to PorkNetwork.com, an industry magazine, “making this sort of regulatory action voluntary allows FDA to rely upon industry resources for some of the burden of implementation, rather than expending its own scarce resources to take strict enforcement action.”
Rep. Louise Slaughter (D-N.Y.) is concerned that the FDA’s voluntary regulations will be ignored by farmers.
“The FDA’s voluntary guidance is an inadequate response to the overuse of antibiotics on the farm with no mechanism for enforcement and no metric for success,” Slaughter said in a press release following the release of the proposed guidelines late last year.
Slaughter is sponsoring the bill for Preservation of Antibiotics and Medical Treatment Act, which seeks to legally ban the use of medically important antibiotics for animal growth purposes.
Wednesday also marked the end of a three-month, public comment period on the FDA’s proposed update to the Veterinary Feed Directive, opening the door for the FDA to draft their final VFD rule.
According to the PEW Charitable Trusts, over 200,000 people and 30 organizations commented on the suggested updates to the directive.
The directive is a regulatory mechanism used by the FDA to control the administration of drugs to animals through feed. Before 1996, drugs used in animal feed were generally available over the counter. Today veterinarians must prescribe drugs classified under the directive to farmers.
Among other administrative changes, the proposed rule change would require veterinarians to approve the use of medically important antibiotics for ‘disease prevention’ and treatment purposes, which are still allowed under guidance 213.
Dr. James Pettigrew, professor emeritus at the University of Illinois, said the changes will likely necessitate a closer relationship between farmers and veterinarians, which could put a strain on limited numbers of veterinarians and cause problems for smaller farmers who don’t have a regular relationship with a veterinarian.
Cliff McConville, a small organic farmer in north suburban Barrington doesn’t often need to see a veterinarian, but is concerned about the lack of access to one in his area. “Our large animal veterinarian, the only one that’s close to us, is 82 years old.” Cliff said. “I’m hoping he’ll still be active [because] he’s the only one around here that treats dairy cows… So that is going to be a problem.”
Dr. John Herrmann, professor of public health at the University of Illinois and a former dairy veterinarian points out that veterinarian shortages will be more of a problem in certain regions.
“The problem with having [veterinary] oversight anywhere west of the Mississippi,” said Dr. Herrmann, “is the livestock are so dispersed and there’s so few veterinarians to cover these huge areas.” He suggests one solution to the problem could be video conferences between farmers and veterinarians.
Even so said Herrmann, “95 percent of the time it’s the producer making the decision about when to use antibiotics…vets are only involved 5 percent of the time.”