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Public Statements

Animal Drug User Fee Amendments of 2008

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Location: Washington, DC


ANIMAL DRUG USER FEE AMENDMENTS OF 2008 -- (House of Representatives - July 30, 2008)

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Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.

Prior to 2003, the 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 5 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 5 years, for a total of $98 million. Revenues would be derived from a mix of application, product, establishment and sponsor fees.

The legislation would also improve the uniform collection and reporting of data to FDA on the sales about 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 that 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; otherwise, the agency would 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 5 years, for a total of $27 million. And these additional revenues are designed to help speed up the review process. By Year 5 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.

Mr. Speaker, I am also pleased that the generic drug industry and FDA have been able to work out this agreement. If enacted, 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.

There is a provision in this bill that would improve the speed in which FDA reviews generic drug applications, and that provision 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.

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 that 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.

There is another correction to the FDA Amendments Act that is included in the bill before us. 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, the FDA would issue regulations that would set the specific requirements. In drafting the ``regulations'' approach, the reference to medical devices was inadvertently dropped, and that was a simple mistake. So the bill before us today corrects that mistake.

In closing, I want to thank my Republican colleagues for working for us in a bipartisan fashion to move this bill forward. Mr. Deal, Mr. Barton and of course Mr. Dingell all worked together, so this is, in fact, a bipartisan bill, and a very important bill as well.

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Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.

I just wanted to say that I understand the gentleman's concerns who just spoke, Mr. Buyer, the gentleman from Indiana, and I, too, am very concerned about counterfeit drugs entering the U.S. marketplace. I think the FDA should have the authority to seize and destroy counterfeit drugs. And as the gentleman knows, we are working with him to address this issue in a larger bill that will empower the FDA to protect the consumers from dangerous products, including counterfeit drugs. So I hope that we can continue to work with the gentleman on this matter.

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