A bill that funds new medicines for pets and livestock is headed to President Trump just in time for a critical Wednesday deadline.
The legislation, collectively known as the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, or ADUFA, passed the Senate Tuesday by voice vote after passing the House the same way July 22.
“These agreements will help bring new drugs to farmers and ranchers, families, and veterinarians to keep our pets healthy, prevent outbreaks of disease, and protect our food supply,” Sen. Lamar Alexander, R-Tenn., chairman of the Health, Education, Labor, and Pensions Committee, said on the floor Tuesday.
As with drugs used in humans, the Food and Drug Administration 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 drugs to use on animals who fall ill.
The measures are directed at both generics and the animal equivalent of brand-name drugs, and are part of the Food, Drug, and Cosmetic Act, the law that gives the FDA its power.
Trump must sign the bill into law 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.
Advocates of reducing antibiotics in the meat supply had their eyes on the legislation as a vehicle to advance their cause, but changes ultimately were not included. Scott Gottlieb, the commissioner at the FDA, said Tuesday in a blog post that his agency would be unveiling a five-year blueprint to tackle the issue. Improperly giving animals antibiotics, whether at too high a rate or when they don’t need it, has led to an increase in drug-resistant bacteria that can sicken both animals and humans.
Even without antibiotic language, the user fee program will face some changes under the bills passed Tuesday. They include directing the FDA to give drugmakers more information about what kind of data it can accept when it reviews drug applications, and will require drugmakers to submit applications electronically starting Oct. 1. The cost of the user fees will increase, which will help speed up the approval of medicines.
