House Passes Pallone's Animal Drug User Fee Bill
Washington, D.C. --- The U.S. House of Representatives today passed a bill introduced earlier this year by U.S. Rep. Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, that reauthorizes the Animal Drug User Fee Act (ADUFA) for another five years and creates an animal generic drug user fee. The New Jersey congressman gave the following statement during debate on the House floor. The bill was passed by voice vote.
"Thank you, Madam Speaker. Prior to 2003, the Food and Drug Administration's (FDA’s) review of animal drug submissions was taking over a year and a half to be completed. This obviously led to serious concerns that new and innovative pharmaceutical products were not making their way onto the marketplace in order to treat our nation’s pets, as well as food animals that help sustain the nation’s food supply.
"Accordingly, in 2003 Congress enacted the Animal Drug User Fee Act (ADUFA), which was modeled after the successful user fee programs for the review of human drug and medical device submissions. Like the user fee programs that preceded it, ADUFA authorized the FDA to collect fees to help ensure that the agency had the resources it needed to provide a timely review of animal drug applications.
"The legislation before us today would reauthorize the ADUFA program for another five years. Under this legislation the amount of fees collected for the review of animal drug submissions would increase from $15 million to $24 million over five years for a total of $98 million. Revenues would be derived from a mix of application, product, establishment and sponsor fees.
"The legislation also would improve the uniform collection and reporting of data to FDA on sales regarding animal drugs that contain an antibiotic ingredient.
"During the debate on reauthorization of ADUFA, we heard many concerns about the use of antibiotics in animal populations for non-therapeutic purposes and the threat these practices pose to human health. This bill includes language that would enhance FDA’s current data collection by creating a new antimicrobial animal drug use data report for all food-producing animals. The report puts critical information in one place for FDA so it does not have to search through warehouses of multiple paper reports.
"In addition to the reauthorization of ADUFA, this legislation would establish a new animal generic drug user fee. According to 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. At the end of last year, there was a recorded backlog of 446 submissions waiting for review and agency action.
"Accordingly, the bill before us would provide for the collection of user fees increasing annually from $4.8 million to $6 million over five years for a total of $27 million. These additional revenues are designed to help speed up the review process. 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.
"Madam Speaker, I am pleased that the generic drug industry and FDA have been able to work out this agreement. If enacted, the Animal Generic Drug User Fee Act (AGDUFA) will speed lower cost animal drugs to the marketplace and bring significant savings to ranchers, farmers and pet owners. While that is an important and noteworthy goal, I also think it is equally, if not more important, to ensure a timely review of generic human drug applications.
"There is a provision in this bill that would improve the speed in which FDA reviews generic drug applications, I should also note a provision that is included in the legislation before us that makes a technical correction to the Food and Drug Administration Amendments Act of 2007 as it relates to the application process for obtaining FDA approval of certain new generic drugs.
"Madam Speaker, citizen petitions can be submitted to FDA to raise issues about drugs that are being considered in the application process. At the time of negotiations on the Food and Drug Administration Amendments Act of 2007, an agreed-upon sentence was inadvertently dropped from our final version of the bill. The sentence makes clear that consideration of a citizen petition regarding a drug is to be separate and apart from review and approval of any application for the drug. The language included in the bill we are considering today restores that sentence.
"One other correction to the Food and Drug Administration Amendments Act is included in the bill before us today. This change concerns the types of information to be included in the clinical trials data bank established under that law. More specifically, the issue is adverse-event information on drugs and on medical devices.
"Adverse-event information was clearly intended to be included in the data bank for both drugs and devices. Express, specific requirements to that effect were included in multiple drafts of the legislation. In negotiations, however, it was agreed that, rather than the bill itself including express, specific requirements regarding adverse-event information, FDA would issue regulations that would set the specific requirements. In drafting the 'regulations' approach, the reference to medical devices was inadvertently dropped. It was a simple mistake. The bill before us today corrects that mistake.
"In closing, I want to thank my Republican colleagues for working with us in a bipartisan fashion to move this bill forward in a timely manner."