NPPC fighting for animal drugs market access

Enacted in 2003, ADUFA authorises FDA to collect fees from the animal health industry to be used for the review and approval of animal health products. The fees supplement the agency’s annual congressionally-approved appropriations and have enabled FDA to dramatically reduce its review time of new animal drugs, bringing medications to the market more quickly while maintaining high standards for safety and effectiveness.

Control new diseases
“ADUFA ensures that animal health companies are able to provide in a timely manner products to treat and control the new diseases that our animals will face,” said NPPC president Bryan Black.

“It’s a critical tool needed by the pork industry and veterinarians to maintain animal health and to provide safe, wholesome and nutritious pork.”

Fight challenges
Since ADUFA was signed into law, four new swine health products have come on the market, helping producers fight the increasing challenges that swine respiratory diseases have created for the industry. Additionally, last year alone, veterinarians and pet owners received nine new products to help pets live longer, healthier lives.

Among its recommendations, FDA proposed a new user fee program – the Animal Generic Drug User Fee Act (AGDUFA) – to support the review of generic animal drug applications.

Generic animal drugs
Currently, FDA’s review of generic animal drugs is entirely funded through appropriations. The agency also recommended an ‘end review amendment’ process, which would allow it to work with a drug manufacturer at the end of a review to make corrections to an application, resulting in reduced review time.

FDA also asked that the reauthorised law include an agreement between the agency and industry to participate in ten workshops over the next five years to improve communications between regulators and industry.

Reauthorisation
Lawmakers are expected to take up reauthorisation of ADUFA, which expires Sept. 30, in the coming weeks. The law is expected to generate $98 million in user fees over the next five years; AGDUFA is estimated to bring in $27 million.

“NPPC will be very aggressive in lobbying Congress for a quick, clean reauthorisation of this important law,” said Black. “ADUFA is a top priority for the US pork industry.”

Related websites:
• National Pork Producers Council (NPPC)
• US Food and Drug Administration (FDA)

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