FDA Trying Voluntary Restrictions on Antibiotics

December 29, 2010 — 

The U.S. Food and Drug Administration is trying to get pharmaceutical companies to voluntarily stop providing antibiotics to promote livestock growth.

In a recent meeting with consumer advocates, the agency indicated it is negotiating with one company to remove growth promotion as a labeled use for one antibiotic.

The Obama administration earlier this year proposed to phase out the use of antibiotics to help hogs and other livestock grow more quickly. The administration is concerned that such usage is increasing the prevalence of drug-resistant bacteria that threaten human health.

FDA officials told the consumer advocates it prefers a voluntary approach over the lengthy legal process of restricting the drugs' use, said Steve Roach of Food Animals Concerns Trust.

The agency "seemed quite confident that some company was getting close to doing something," he said.

FDA spokeswoman Siobhan DeLancey declined to comment on the discussions with drug makers beyond saying that the agency "indicated we wanted to work with companies, veterinarians and the industry to minimize use of medically important antimicrobials."

Some doubt whether the agency has sufficient scientific basis to force the companies to ban the growth promotion uses, said Ron Phillips, vice president of legislative and public affairs for the Animal Health Institute, a trade group for the drug makers.

But the FDA is still "pursing this diligently. They would like to continue to see progress made on this," said Phillips.

The FDA this month released its first data gathered on the usage of the drugs. The agency said that companies sold 29 million pounds of antibiotics in 2009 for use in food animals. Drugs used as growth promotants in hogs include virginiamycin. Pork and turkey producers are among the industries most reliant on antibiotics for growth promotion.

About two-thirds of the drugs sold are similar to antibiotics used in humans.

The drugs are added to the feed at a low dose approved by the FDA to fatten animals faster, saving on feed costs and boosting farmer profits. The drugs apparently allow pigs to better absorb nutrients by killing off bacteria in their guts, scientists say.

The issue is especially important in Iowa, which is by far the nation's largest producer of hogs.

Consumer advocates fear that the voluntary approach will allow companies to drag their feet about limiting usage of the drugs.

"It's very easy for the companies to be on board when they talk to the FDA as long as it keeps the FDA from taking legal action against them," said Roach.

Agency officials indicated the industry would resist efforts to impose restrictions on the drugs, said Susan Vaughn Grooters of the group Safe Tables Our Priority. She also was in the FDA meeting. Agency officials in the meeting included Bernadette Dunham, director of the Center for Veterinary Medicine, which regulates the drugs.

One reason drug makers are concerned about restrictions is that they believe the drugs also protect animals from disease, even at the low doses labeled for growth promotion, according to Phillips.

The FDA has said it would continue to allow drugs to be used for disease prevention.

Many advocacy groups have argued that allowing the drugs to be used for prevention leaves a large loophole. They want the drugs banned for every use but treating sick animals, as Denmark did.

But legislation to ban the subtherapeutic use of antibiotics in U.S. livestock went nowhere in the current Congress, and prospects are even dimmer with Republicans taking over the House next year.

The legislation's chief sponsor, Rep. Louise Slaughter, D-N.Y., said she isn't giving up on her bill although she will lose her platform to promote the issue when she loses her chairwomanship of the House Rules Committee in January.

"What we're doing is creating super bugs and creating resistance to antibiotics, which is stupid in the extreme," she said.

Producer groups say that restricting antibiotic usage would drive up production costs. They argue that there is insufficient scientific evidence that drug-resistant bacteria move from animals into food.

Source:
Des Moines Register,
BY PHILIP BRASHER