The U.S. House Energy and Commerce Committee has approved a "clean" reauthorization of an animal-drug review law and a new generic animal-drug review statute, according to the National Pork Producers Council.
The Animal Drug User Fee Act, first enacted in 2003, allows the Food and Drug Administration to collect fees from the animal-health industry for the review and approval of animal-health products. The fees supplement the agency’s annual congressionally approved appropriations and have allowed FDA to dramatically reduce its review time for new animal drugs, bringing medications to the market more quickly while maintaining high standards for safety and effectiveness. The Animal Generic Drug User Fee Act would do the same for generic animal drugs. 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 applauds the leadership of Energy and Commerce Committee Chairman Dingell (D-Mich), Ranking Member Barton (R-Texas) and Subcommittee on Health Chairman Pallone (D-N.J.) and Ranking Member Deal (R-Ga.), for working with pork producers and the veterinary community to take up the measure before it expires on Sept. 30.
Pork producers have always supported science-based efforts to protect public health. Today’s bill included enhanced animal-health company reporting requirements to further promote public health. These additional requirements do not limit producer access to important animal-health products.
NPPC urges swift action by the House and Senate to reauthorize ADUFA and approve AGDUFA before the August recess.
Since ADUFA was signed into law in 2003, 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, note NPPC officials. Also, last year alone, veterinarians and pet owners received nine new products to help pets live longer, healthier lives.
“Passing ADUFA favorably through the House Energy and Commerce Committee is a win for pork producers. I urge Congress to quickly approve both ADUFA and AGDUFA without additional amendments that would make it more difficult to keep animals healthy and maintain a safe food supply,” says Bryan Black, NPPC president and Ohio pork producer.
Source: National Pork Producers Council