[Congressional Record Volume 154, Number 141 (Monday, September 8, 2008)]
[Senate]
[Pages S8115-S8116]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




       REAUTHORIZATION OF THE ANIMAL DRUG USER FEE ACT, H.R. 6432

  Mr. ENZI. Mr. President, I rise today in support of H.R. 6432, a bill 
that reauthorizes the Animal Drug User Fee Act, or ADUFA, and create a 
new user fee for the approval of generic animal drugs. This bill also 
addresses the use of antibiotics in animals, and technical corrections 
to last year's Food and Drug Administration Amendments Act.
  Like human drugs, animal drugs must be shown to be safe and effective 
before they can be marketed. An animal drug can take 7 to 10 years to 
develop, at a cost of $100 million or more. ADUFA supports the review 
of animal drugs by authorizing FDA to collect fees for animal drug 
applications, and for the establishments, products, and sponsors 
associated with these products.
  This program is similar to the user fee programs for human drugs and 
medical devices which we renewed last year. Like those programs, ADUFA 
expires October 1. If we do not act on this bill, 60 valuable FDA 
employees could be laid off. Even if we simply delay renewal of this 
program, those employees will receive a ``reduction in force,'' or RIF 
notice, indicating they might be let go. Many will make that 
possibility a reality, and leave the agency, taking their talent with 
them.
  ADUFA has been a success. The program has eliminated the review 
backlog for new animal drugs, improved the timeliness and 
predictability of reviews, and improved communication between companies 
and the FDA throughout the process. The renewal of this program will 
continue to enhance FDA review capacity, including more support for 
increasingly complex reviews. Also, there is a growing backlog of 
premarket inspections of foreign animal drug producing facilities, 
which is a very timely issue. The renewal of ADUFA would better 
prioritize those inspections, and eliminate the backlog, helping to 
keep our animal drug supply safe.
  The renewal of this important animal health program would nearly 
double funding levels to $98 million over 5 years. I want to be clear 
that the renewal of this program does not speed up the review of new 
animal drugs. It holds FDA to the same performance goals for review 
times--it just keeps review times from getting slower.
  The bill we are considering today contains another important advance 
for animal drugs. Under the Food, Drug and Cosmetic Act, FDA is 
required to review and act on generic animal drug applications within 
180 days. Unfortunately, in fiscal year 2007, the average review time 
for generic animal drug applications was 570 days, and there was a 
backlog of 446 of these submissions. Without Congressional action,

[[Page S8116]]

the proposed target for action in fiscal year 2009 is 700 days--nearly 
2 years. This is an untenable position.
  We all know that FDA is seriously underfunded. Like many of you, I 
would prefer that appropriations be used to fund the agency's 
activities. But that is simply not in the offing. An appropriated 
dollar is better than a user fee dollar, but a user fee dollar is 
better than no dollar at all. The Animal Generic Drug User Fee Act 
under consideration today would create a new program to fund the 
reviews of animal generic drugs. This program will lead to progressive 
improvements in performance, with the time for review and action on 
submissions decreasing each year.
  If we do not proceed with this initiative, our farmers, ranchers, 
veterinarians and pet owners like you and me will not be able to 
capture the savings that result from generic animal drug use. I want to 
point out that even with the creation of this new user fee, the 
performance goals do not return animal generic drug review times to the 
statutory requirement of 180 days. By fiscal year 2013, the fifth year 
of the program, the proposed review target is 270 days. Once again, the 
best we can do is to keep things from getting much worse as quickly.
  The bill before us today also includes a section expanding and 
streamlining the reporting of the amount of antibiotics that are used 
to treat animals that are sold annually and the label information about 
those antibiotics. This reporting language is a carefully crafted 
compromise between the farmer, rancher and veterinarian communities on 
one side and those who think the FDA has inadequate information to 
assess the potential public health impact of antibiotic use on the 
other. I appreciate the House Members and staff and outside groups who 
worked together to achieve this agreement.
  Finally, this bill contains just two of several changes necessary to 
properly implement the Food and Drug Administration Amendments Act of 
2007. As with any large piece of legislation, there are some technical 
corrections necessary to fix inadvertent errors in the law.
  These technical corrections are critical to ensuring that key drug 
safety and transparency provisions in the bill work as intended. I am 
disappointed that we could not complete agreement on a package in time 
to attach the package to ADUFA. I am even more discouraged that the 
House chose to cherry-pick just the technical corrections they wanted 
and attach those instead.
  But given the approaching deadline for renewing ADUFA, we cannot 
afford to hold this important program hostage to unrelated provisions. 
I intend to continue pressing for passage of a full package of 
technical corrections. I appreciate Chairman Dingell's commitment to 
continuing to meet and work on this, and I look forward to preparing a 
full package of technical corrections that can be accepted by both 
Houses and go into effect.
  I thank my colleagues for their hard work on these proposals. We have 
some work still ahead of us, but the bill before us today contains much 
that is good. I strongly urge my colleagues to support final passage.

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