By CELESTE BAUMGARTNER
Ohio Correspondent

WASHINGTON, D.C. — The National Pork Producers Council (NPPC) urged Congress to reauthorize the Animal Drug User Fee Act (ADUFA) after the U.S. Food and Drug Administration (FDA) sent recommendations for the law to Capitol Hill.

“ADUFA authorizes the FDA to collect fees from the animal health industry to be used for the review and approval of animal health products,” said NPPC President Bryan Black, a pork producer from Canal Winchester, Ohio. “The fees supplement the agency’s annual Congressionally-approved appropriations and have enabled FDA to dramatically reduce its review time of new animal drugs.

“ADUFA is in the process of being reauthorized,” Black said. “It’s one of Sen. Ted Kennedy’s responsibilities, so it is a bit up in the air because of his health situation (the Massachusetts Democrat was recently diagnosed with a malignant brain tumor).

“Until last weekend, we thought everything was going smoothly with that process; but of course, since his diagnosis, there will have to be additional time.”

The law allows manufacturers of animal health products to get more timely approval of their new products, said Jennifer Greiner, director of science and technology for the NPPC.

“What that means for producers is that new products get approved faster, so we get new technology to the marketplace much more quickly,” Greiner said. “It was first put into place in September of 2003 as a five-year authorization for $43 million.”

The pork industry has benefited with four new products since ADUFA was first put in place, Greiner said. All four treat respiratory or lung disease.

“They’re for nasty bugs that hurt the lungs,” she said. “These antibiotics help treat those lung infections. They were able to get on the market more quickly because of ADUFA.

“We just want ADUFA passed very cleanly without mischief on it, and we definitely want to see it reauthorized before the first ADUFA agreement expires on September 30.”

She defined “mischief” as talk of adding on anti-antibiotic legislation seen as onerous by pork producers because they would have to report back to FDA about how antibiotic products are used.
“There are some measures that are very negative for pork producers and we just want to keep all that mischief off, and we can talk about antibiotics at another time,” Greiner said.

NPPC’s standard line on antibiotics is that producers use them responsibly, she said.

They’re working closely with their veterinarians to decide the protocols for their antibiotics’ use and they are using antibiotics to ensure that the public has a safe meat product.

Black added, “The bottom line of why we want to support ADUFA and maintain it is: We need new, very well-thought-out drugs from these drug companies to help the challenges the pork industry faces on occasion. We see this as a very good process of checks and balances to make sure that not only what the producer is using is going to be safe, but that it has gone through the proper channels with USDA and other agencies to make sure that it is safe and effective.”

The law is expected to generate $98 million in user fees over the next five years; the ADUFA is estimated to bring in $27 million.