Animal Drug Malpractice Attorneys Greenville SC

President Bush signed into law the Animal Drug User Fee Amendments of 2008 (H.R. 6432) on Thursday, which among other things, authorizes a new user fee program for animal generic drugs.

Under the Animal Generic Drug User Fee Act of 2008, animal health companies will have to pay user fees based on three categories: 1) application fees; 2) generic new animal drug product fees; and 3) generic new animal drug sponsor fees.

These funds — estimated to bring in about $27 million over five years — would in turn be dedicated toward expediting the development process and the review of applications for new generic animal health drugs.

“According to the FDA, the average review time of an animal generic drug submission was 570 days in fiscal year 2007, in spite of a 180 day statutory requirement,” sponsor U.S. Rep. Frank Pallone Jr. [D-N.J.] said in a statement. “At the end of last year, there was a recorded backlog of 446 submissions waiting for review and agency action … By year five of the authorization period, most reviews of generic animal drug submissions should occur in 270 days or less, a substantial improvement over the time it is now taking FDA to conduct such reviews.”

Congress said that prompt approval of these applications will reduce animal health care costs and promote animal and public health.

“The [Animal Generic Drug User Fee] legislation marks the beginning of a new era for animal health,” said Jean Hoffman, chief executive of Putney, which is a member of th...

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