[Congressional Record (Bound Edition), Volume 154 (2008), Part 13] [Senate] [Pages 17780-17781] [From the U.S. Government Publishing Office, www.gpo.gov]ANIMAL DRUG USER FEE AMENDMENTS OF 2008 Mr. REID. Mr. President, I ask unanimous consent that the Senate proceed to the consideration of H.R. 6432. The ACTING PRESIDENT pro tempore. The clerk will report the bill by title. The legislative clerk read as follows: A bill (H.R. 6432) to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, to establish a program of fees relating to generic new animal drugs, to make certain technical corrections to the Food and Drug Administration Amendments Act of 2007, and for other purposes. There being no objection, the Senate proceeded to consider the bill. Mr. REID. Mr. President, I ask unanimous consent that the bill be read a third time and passed, the motion to reconsider be laid upon the table, that there be no further debate, and that any statements relating to the bill be printed in the Record. 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 [[Page 17781]] 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, 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. The ACTING PRESIDENT pro tempore. Without objection, it is so ordered. The bill (H.R. 6432) was ordered to a third reading, was read the third time, and passed. ____________________