The House recently agreed to reauthorize two bills that support the testing and review of brand and generic animal drug applications by the Food and Drug Administration.
The legislation, sponsored by Reps. Cory Gardner (R-Col.) and John Shimkus (R-Ill.), extended the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act. The House passed the bill in a 390-12 vote on Monday.
The ADUFA/AGDUFA reauthorization recently passed the Senate as well and awaits President Barack Obama’s signature.
“Companies dedicated to animal health rely on ADUFA/AGDUFA to provide a predictable and science-based review process for animal drugs,” Gardner said. “This reauthorization will allow them to benefit from a more stable process, so they can make decisions about where to invest research dollars.”
Prior to the initial passage of the two acts, there was a backlog on the applications at FDA for animal drugs. The backlog hurt the industry that manufactures the medications and impacted livestock producers because herds suffered without the drugs.
The Center for Veterinary Medicine and FDA are responsible for ensuring that animal drugs are safe, effective and manufactured to the highest quality standards. The legislation allows them to continue collecting user fees from drug manufacturers to pay for the program.