Reauthorization of drug act

Jun 7, 2013

The House of Representatives last week passed S.622, the Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013, by a huge margin—390 to 12. The legislation reauthorizes the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act that expire at the end of Fiscal Year 2013. The programs have ensured that veterinarians, livestock and poultry producers, and pet owners have access to the drugs they need to keep their animals healthy. Environment and the Economy Subcommittee Chairman John Shimkus, R-IL, and Rep. Cory Gardner, R-CO, led the effort to renew these important programs.

“Human health is impacted by animal health, and the bills passed today impact both,” said Shimkus. “These bills provide continued access to safe and effective animal drugs. Without reauthorization, the FDA would not be able to continue these vital programs.”

Speaking in support of the legislation, Gardner said, “These programs have been a success story at the FDA, and this legislation will ensure that drug approvals are done efficiently and to the highest quality standards. … This bill will also help companies that develop and manufacture animal drugs by providing predictable timelines. It will also help them to benefit from a more stable review process, so they can make decisions about where to invest research dollars.”

“Having medications that keep our animals healthy is essential to keeping our nation’s food supply safe,” said Energy and Commerce Committee Chairman Fred Upton, R-MI. “For companies like Zoetis, which employs some 700 people in southwest Michigan, these programs are vital in allowing them to keep producing innovative drugs for pets and livestock.”

With the passage of ADU- FA last month in the Senate, the legislation, which authorizes the Food and Drug Administration (FDA) to collect fees for certain animal drug applications, now heads to the White House for the president’s signature.

National Cattlemen’s Beef Association’s President Scott George, a dairy and beef producer from Cody, WY, said the passage of ADUFA is important because new animal health technologies allow cattle producers and veterinarians to prevent, control and treat diseases to maintain a healthy herd.

“Raising healthy cattle is of utmost importance to cattlemen and women, and it is important for producers and the veterinarians they work with to have the ability to best manage herd health and produce safe, nutritious beef,” said George. “The reauthorization of ADUFA will provide resources for the FDA to conduct timely and thorough reviews of new animal drugs for safety and effectiveness.”

George added that with a “clean” bill free of amendments, the fees paid by animal health companies to fund FDA reviews and evaluations will be utilized to support and facilitate the new animal drug approval process.

“Cattle producers know that keeping our animals healthy is critical to the viability of our operations and our industry,” said George. “We sincerely thank the Senate and House leadership for working together to pass this legislation and for realizing the importance of passing a clean bill without unnecessary language or amendments.” — Traci Eatherton, WLJ Editor