July 11, 2008


US pork producers urge for drug-review law

The National Pork Producers Council (NPPC) is urging the Congress to reauthorise an animal-drug review law, to approve a new generic animal-drug review statute and to pass both measures without amendments that would make it more difficult to keep animals healthy.

The Animal Drug User Fee Act (ADUFA), first enacted in 2003, allows FDA 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 enabled 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.

Congressional debate about the ADUFA reauthorisation has included the issue of antibiotic resistance and the possibility that antibiotics used in livestock are contributing to antibiotic resistance in people. Some lawmakers have indicated support for adding language to the reauthorisation bill that would ban the use in livestock of certain antibiotics.

But the American Veterinary Medical Association recently testified that risk assessment is the proper basis for making policy decisions about antibiotic use in animal agriculture. Indeed, many quantitative risk assessments have been done on antibiotic products used to keep animals healthy, all showing extremely low levels of risk to human health.

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.

ADUFA ensures animal health companies are able to provide products to treat and control new diseases in a timely manner and it is critical in maintaining animal health and in providing safe pork, according to NPPC president Bryan Black.

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