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Washington, D.C. --- U.S. Rep. Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, gave the following opening statement at a subcommittee hearing today on the Animal Drug User Fee Act (ADUFA) Amendments of 2008 and the Animal Generic Drug User Fee Act (AGDUFA) of 2008.
"Good morning. Today the Subcommittee is meeting to review the Administration’s legislative proposals on the Animal Drug User Fee Act (ADUFA) Amendments of 2008 and the Animal Generic Drug User Fee Act (AGDUFA) of 2008.
"Prior to 2003, 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 Food and Drug Administration (FDA) to collect fees to help ensure that the agency had the resources it needed to provide a timely review of animal drug applications.
"ADUFA also set new performance goals for FDA to review and act upon submissions within a stated time frame. By the fifth year of the authorization period, FDA was supposed to review 90 percent of submissions within the statutorily required timeframe of 180 days. According to the required annual performance reports for the most recent fiscal years, FDA says that the agency has been meeting or exceeding the timeliness goals established under the program. I am looking forward to hearing more from FDA about how this program has been working over the past five years and how it may be improved upon.
"Under the Administration’s legislative proposal to reauthorize ADUFA, the review times would remain the same as the existing performance goals for Fiscal Year 2008. The proposal would increase the amount of fees collected 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. Other important provisions of the Administration’s proposal include a new End-Review Amendment Process and improved communications between FDA and the regulated industry.
"Absent from the Administration’s proposal, however, is any provision relating to the issue of antimicrobial resistance. I recognize that there is a growing concern among stakeholders and Members of this Subcommittee about the use of antibiotics in food animals for prophylactic and/or growth purposes. As these practices become more commonplace, bacteria that are resistant to antibiotics begin to proliferate. This poses a significant threat to humans who may come into contact with antibiotic-resistant bacteria through eating contaminated or undercooked meat; by caring for livestock; or through polluted waterways.
"Clearly, we face significant challenges when it comes to maintaining the effective use of antibiotics. With fewer and fewer innovative antibiotic products coming down the pharmaceutical pipeline, it is even more important that we keep antibiotics that are currently on the market working. I am anxious to hear testimony both from the FDA and the witnesses on our second panel about the problem of antibiotic resistance and what, if any considerations, should be made regarding this issue as we move forward with reauthorizing ADUFA.
"In addition to the reauthorization of ADUFA, the Administration has offered a proposal to 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. As more and more brand pharmaceuticals come off patent over the next few years, we need to make sure that FDA has the resources it needs to effectively review generic animal drug submissions in a timely manner.
"Accordingly, the agreement between FDA and the industry 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, including the yearly cost of inflation. These additional revenues are designed to help speed up the review process. Accordingly, 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.
"I am pleased that the industry and FDA have been able to work out this agreement and I am looking forward to hearing more about it today. If implemented, 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 for the timely review of generic human drug applications.
"Over the past few years I have tried to work to improve the speed in which the agency works to review generic applications for human drugs. We have lobbied appropriators for additional monies for the Office of Generic Drugs.
"Additionally, last year we included a provision in the Food and Drug Administration Amendments Act of 2007 to reform the citizen petition process, which has been abused in an effort to delay agency approval of generic applications. While steps have been taken to improve the efficiency in which the agency is reviewing generic human drug applications, more can and should be done to help ensure patients have access to cheaper and safe medicines. I think we just need to keep that in mind, even today, as we are talking about animal drugs.
"Thank you to all the witnesses for being with us today."
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