Advocates of reducing antibiotics in the meat supply have their eye on legislation that would speed up the approval of medicines for pets and livestock as a way to advance their cause, but opponents worry any such efforts could trip up the legislation's passage and put animal safety at risk.
The two bills, collectively known as the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, must be reauthorized this year, with one directed at generics and the other directed at the animal equivalent of brand-name drugs. They are part of the Food, Drug, and Cosmetic Act, the law that gives the Food and Drug Administration its power. The bills have advanced out of a Senate committee and will be considered in House committee.
As with drugs used in humans, the FDA charges fees for drug and device applications and uses that money to speed up their review. That way, products can head to market faster, and animal owners can have less expensive or more effective medical options. Dr. Steven Solomon, director of FDA's Center for Veterinary Medicine, said during a Senate hearing that the creation of the fees had eliminated backlogs that had lasted as long as two years for innovative drugs.
The user fees repeatedly have received bipartisan support, but a push has emerged to attach language to the law that would restrict or add more reporting requirements on the use of antibiotics in livestock. Every year, roughly 2 million people become infected with "superbugs," bacteria that are resistant to antibiotics, and at least 23,000 people die each year as a result of those infections, according to the Centers for Disease Control and Prevention.
One of the reasons for the rise in superbugs is the improper or overuse of antibiotics, which are prescribed too often to people but also given to animals that are used for meat. The overuse or improper use makes bacteria such as salmonella, E. coli, and Campylobacter stronger and resistant to drugs previously able to fight them off. In a farm setting, bacteria can not only spread to other livestock in close quarters, but also to farm workers who slaughter the animals, and eventually to customers who eat infected meat. Public health advocates say the government should step in more.
But passing legislation to tackle antibiotics has received lukewarm support in Congress over the years. Rep. Louise Slaughter, D-N.Y., who several times has reintroduced the Preservation of Antibiotics for Medical Treatment Act, which would implement a range of changes to how antibiotics are used, has been vocal on the House side about the need to overhaul the laws.
“I would say that we would only use antibiotics in the case of a sick animal,” she said. “Otherwise, we would make sure they are in sanitary conditions and are allowed to grow naturally.”
Advocates who support her bill would like some steps on antibiotics included in the user fee bills. While it's not clear the debate will slow or jeopardize reauthorization, many lawmakers, as well as the meat industry, remain opposed to legislation on antibiotics, saying that voluntary changes are already taking place. They worry about bans on antibiotics, saying they would be unethical because they would cause suffering and death among livestock. For instance, when the World Health Organization in November called for a ban on using antibiotics to prevent disease, rather than in response to an infection, the National Pork Producers Council called it "ill-advised and wrong."
The meat industry notes that it has followed federal rules that it stop giving antibiotics to animals to help them grow faster. When antibiotics are administered, they are done with veterinary oversight, they say, and producers have voluntarily made other cutbacks.
A few months remain to see whether antibiotic language will be included in the user fee legislation. The user fee bill must be signed into law by President Trump by Aug. 1, or the 115 staff who work in the unit to review the drug and device applications will be notified that they will lose their jobs by Oct. 1.
"Failure to reauthorize would be very disruptive," Solomon said in a hearing. "The industry is counting on this. There is constant reviews, and we get over 6,000 submissions a year."
The Food Animal Concerns Trust, which advocates for humane production of meat and other animal products, has been promoting antibiotic actions in the user fee bill. It has two requests: Including language asking the FDA to take action on how long animals can be prescribed antibiotics, so they aren't on them for their entire lives until they are slaughtered, and requiring more farmers and ranchers to report information about how they administer antibiotics, rather than depending on data provided by drug companies.
"I think it's pretty clear the beef and the pork are the big users, but we don't really know for what reasons," said Steven Roach, food safety program director for the group.
He noted that despite measures the FDA has taken, it's not clear why farmers and ranchers are still giving animals antibiotics, and whether they are giving them even when an animal does not have any sign of illness.
The FDA did not include antibiotic recommendations when it presented its proposals to Congress about the user fee bills. Democratic Sens. Elizabeth Warren of Massachusetts, Patty Murray of Washington, and Maggie Hassan of New Hampshire raised questions about antibiotics in livestock during a hearing on the bill, though all voted in favor of moving the bill out of committee without antibiotic language attached.
The timeline on the Senate side to bring the bill to the floor, and whether antibiotic amendments might be offered then, isn't clear. The House hasn't scheduled its hearing on user fees.
"There has been some interest on the House side, so we are still hopeful," Roach said of the possibility of antibiotic language making it in.
User fee legislation has included antibiotic reporting requirements before. The reauthorization that passed in 2008 required drug companies to report to the FDA the number of antibiotics that they distributed to farms and ranches each year. It also required the FDA to collect that information and issue summary reports about it, and to make that information available to the public.
The data show how many drugs entered the marketplace but do not show how they are used. In 2016, the FDA expanded on the act by issuing a final rule asking drug companies to estimate the breakdown of drugs by major food types: Pork, beef, turkey, or chicken. Reports beginning in 2010 showed an increase in antibiotic sales each year, but the latest report indicated a 10 percent decrease from 2015 to 2016.
The Animal Health Institute, a trade group for drug companies that sell the antibiotics, pointed to the decrease and to the reporting requirements already in place, saying a change in antibiotic policy was not needed as part of the user fee bill.
"Antibiotics are not a part of the user fee agreement, however, the legislation has always been an opportunity for Congress to delve into this issue because it has to do with the same agency," said Ron Phillips, vice president for legislative and public affairs at the Animal Health Institute.
The American Veterinary Medical Association, while supportive of using antibiotics judiciously, said the user fee legislation is not the right time to consider changes to laws on antibiotics, given that additional information will continue to emerge from FDA reports and from data being collected by the Department of Agriculture.
"We would like to see those efforts play out. We think that they are appropriate for the circumstances," said Dr. Kent McClure, chief government relations officer for the American Veterinary Medical Association.
A "clean bill," meaning one that carries few changes from the original version, will more easily be able to move through Congress.
Even without antibiotic language, some changes are ahead, such as directing the FDA to better inform drugmakers about what kind of data it can accept when reviewing drug applications, as well as a new requirement to submit requests electronically beginning Oct. 1. The cost of the user fees will increase again, which will help speed up approvals of medicines.
McClure said that would help bring more drugs to market, which is important because there aren't enough FDA-approved drugs to meet animals' needs. Veterinarians often turn to drugs that are approved for humans, such as those aimed at behavioral disorders, cancer, and heart disease. Though some of these medications can be effective, veterinarians don't have all the research they need to back their prescribing habits.
"We prefer to have them approved for animals because we know they are safe and effective in a particular species," McClure said.
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