The bill, previously introduced in June 2013, would require the Food and Drug Administration (FDA) to withdraw its approval of medically important antibiotics used for disease prevention or control that are at a high risk of abuse.
The sponsors and other supporters say that PARA addresses gaps in FDA’s Guidance #213, introduced in December 2013, which asks animal pharmaceutical companies to remove growth-promotion claims from medically important antimicrobial drugs in food-producing animals.
Critics of the policy are concerned that the drugs could be re-listed with new “disease prevention” labels and still be used at the same levels as growth-promotion doses and without a limit on duration.
“Our bill would build on efforts by the FDA to reduce antibiotic overuse in food animals, through the voluntary policy to eliminate approved growth-promoting uses and improving veterinary oversight, by helping to ensure the appropriate use of antibiotics for preventing and controlling disease in food animal production,” Collins said.
Under PARA, if a drug producer can demonstrate that its use in agriculture does not pose a risk to human health, the drug would be issued a new label that supports “prudent” antibiotic use.
“Antibiotic resistance is one of the biggest public health threats we face and we need a comprehensive response to preserve the effectiveness of antibiotics,” Feinstein said.
The Prevention of Antibiotic Resistance Act is co-sponsored by Senators Kirsten Gillibrand (D-NY) and Elizabeth Warren (D-MA) and has been endorsed by the American Public Health Association, the Infectious Disease Society of America, Trust for America’s Health, the American College of Preventive Medicine and the Pew Charitable Trusts.© Food Safety News