By Sarah Everhart
According to the U.S. Center for Disease Control, at least 2 million people in the United States become infected with bacteria resistant to antibiotics each year, and at least 23,000 people die as a direct result of these infections. To address this health concern, identical bills have been introduced into the Maryland House (HB829) and Senate (SB607) which aim to prohibit producers from administering antibiotics or antimicrobial drugs to cattle, swine, or poultry without a prescription or veterinary feed directive (VFD) issued by a veterinarian. Each branch of the legislature has had an initial hearing on the respective bills though it is unclear at this point whether either will proceed in the legislative process.
According to a story published February 26, 2016 in the Carroll County Times, Sen. Nathan-Pulliam, who is one of the bill’s sponsors as well as a registered nurse , explained the reason she sponsored the SB607, “[w]hen farm animals are given antibiotics in their feed and we eat it, we can develop resistance.” In the same story, the Maryland State Veterinarian Dr. Michael Radebaugh explained the bills are essentially a duplicate of the Food and Drug Administration’s (FDA) new animal feed regulations which will go into effect starting 2017.
What is the FDA doing?
Currently, livestock producers can buy feed-grade antibiotics over the counter at a feed mill. In 2013, the FDA released a voluntary guidance document, New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (Guidance #213). The document guides drug companies to voluntarily revise the FDA-approved labeled use conditions to (a) remove the use of antimicrobial drugs for production purposes; (b) add scientifically-supported disease treatment, control, or prevention uses where appropriate; and (c) change the marketing status from over-the-counter to VFD for drugs administered through feed or to prescription status for drugs administered through water to provide for veterinary oversight or consultation. FDA has also updated the agency’s existing regulations relating to VFD drugs.
Although FDA made some updates to its regulation, its approach to phasing out over-the-counter antibiotic use is a voluntary strategy. The regulation requests drug sponsors to work with FDA to revise the approved use conditions for their medically necessary antimicrobial drug products, removing production uses (such as growth enhancement or feed efficiency), and bringing the remaining therapeutic uses under veterinary oversight. Once manufacturers voluntarily make these changes, products can no longer be used for production purposes, and therapeutic use would require veterinary oversight. Although this is a voluntary program, once product labeling is voluntarily changed, it will be a violation of the Federal Food, Drug, and Cosmetic Act to use these products in feed for production purposes.
How will the new system work?
Starting Jan. 1, 2017, veterinarians will have to write a VFD or prescription for medically important antibiotics (examples- penicillin or sulfa) use in livestock feed and those antibiotics can only be used to treat specific health concerns. Once the farmer gets the prescription, he will have to fill it at a distributor who has registered that specific prescription with the FDA. The veterinarian, farmer and distributor are required to keep the VFD paperwork for two years.
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