President Trump has signed a bill into law that extends a program funding medicines for pets and livestock.
The legislation, collectively known as the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, or ADUFA, 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.
The legislation needed to be extended quickly in order for the 115 staff who work in the drug review unit not to lose their jobs by Oct. 1. The bill must be re-authorized every five years.
The latest version of the user fee bill directs 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 user fees will also increase, which will help speed up the approval of medicines.
The legislation passed the Senate July 31 by voice vote after passing the House the same way July 22.
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.
