NPPC fighting for animal drugs market access
The US National Pork Producers Council (NPPC) has urged Congress to
reauthorise the Animal Drug User Fee Act (ADUFA), after the US Food and Drug
Administration sent recommendations for the law to Capitol Hill, last
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
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."
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.
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
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
â€¢ National Pork Producers Council (NPPC)
â€¢ US Food and Drug Administration
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