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Transcript

ADUFA II Reorganization -- Public Meeting

Tuesday, March 11, 2008

I N D E X

Introduction - by Aleta Sindelar, Staff, CVM

Welcome - by Bernadette Dunham, D.V.M., Ph.D.

Sound Financial Footing - by Gary Claywell

Presentation: Performance Goals - by Steven D. Vaughn, D.V.M.

Public Comment

by Richard A. Carnevale, D.V.M.

by Brise Tencer

by Barb Determan

Closing Remarks - by Aleta Sindelar

KEYNOTE: “---” indicates inaudible in transcript.


AFTERNOON SESSION

(1:08 p.m.)

Introduction

by Aleta Sindelar, Moderator

MS. SINDELAR: Good afternoon, everyone. Welcome to the ADUFA Reorganization Public Meeting. It is a real pleasure to have you all here.

I would like to be -- I would like to introduce Dr. Bernadette Dunham. She is our new Center Director. We are so pleased to have her in this position, and it is an honor to have her come and speak first. Thank you.

Welcome

by Bernadette Dunham, D.V.M., Ph.D.

DR. DUNHAM: Thank you so much. I appreciate that, Aleta.

(Slide)

DR. DUNHAM: Well, thank you all, and welcome to the ADUFA reauthorizing public meeting. We are so delighted to have you here and we look forward to hearing from you.

It has really been terrific, I think personally, to see how well ADUFA I has come and has delivered, I think, on everything it asked to for performance-based goals that we had set. And we have been -- anxiously been working, actually since April of 2007, with the regulated drug industry as well as outside groups, to get it back into discussion to see if could possibly reformulate then a new proposal for what we will call ADUFA II, and that is the reauthorization of ADUFA. And I think through that we have really had some really good discussions and we are very happy to now have this public meeting to discuss further where we are going to be going.

We really have actually been building on the successes that we have had with all of the work with ONADE and industry and I think we have managed very much to do just that. We have had our performance results. We have increased our staff. We have added new guidance in policies and procedures. We further augmented the management practice. And we have done the goal, which was to shorten review times, and by doing that, managing very much to get the needed medications to the groups that need them the most, and that is really important.

(Slide)

Through doing that, we have been sustaining this performance and we have therefore managed the resources, I think, very wisely, as you will see from further discussions today. We have actually tried to really focus on making strategic investments into our infrastructure in how we can coordinate what we do. And overall, we definitely are committed to improving the review efficiency, the quality and our predictability of the review that we do. It is very important.

(Slide)

I think the ADUFA benefits have been pretty clear. Overall, it really has been just that -- helping our veterinarians and producers to access safe and effective drugs on a very timely basis, which is very important on both accounts, both to the development of the drugs from industry’s point of view and to the needed users of those safe and effective drugs.

I think more importantly, as we can do this for industry, we rely on them to take the opportunity for the profits, to turn it back around and invest in research and development and to continue that pipeline of very needed new drugs and also for them to be able to take advantage of new technologies, and that is a really important growth area that we are seeing now more and more.

(Slide)

I think this afternoon it will be very interesting as we now get a chance with a public meeting to hear comments. We will have an opportunity, first of all, from CVM’s point of view, to give you a bit of background information on ADUFA as we have gone through the reauthorization process, and for that we will give you an overview of the financial oversight and our performance update. And then what we will do is open it up to the audience, and we welcome your comment, and as you well know, comments are also being given to the docket as well.

So it is a very short introduction, but I am very, very proud of everything we have accomplished and I hope I hear similar comments from the group this afternoon, and we do hope it is a productive afternoon.

So on that note, I get to hand it over to Mr. Gary Claywell, our Deputy Director, Office of Management, who will give you the financial overview of ADUFA for reauthorization.

Thank you.


Presentation: Sound Financial Footing

by Gary Claywell

MR. CLAYWELL: Good afternoon. I am Gary Claywell, Deputy Director for the Office of Management, and I was also a participant on the ADUFA negotiation team for FDA. And what I am going to talk about this afternoon is the financial features of the ADUFA reauthorization program.

(Slide)

First, I want to provide background on the financial features negotiated.

We entered the reauthorization negotiations with industry with one overriding goal -- to give the ADUFA program a sound financial footing that would enable the success of the previous program to continue.

(Slide)

Under ADUFA, we noted that the resources available from both fees and appropriations could not keep up with our costs. In fact, we look at costs across the Agency over 5 years and found that, on average, our costs were 5.9 percent, increased at 5.9 percent.

(Slide)

These rising costs, combined with the fact that our appropriations increased only by 2.6 percent, meant we had a gap between what we had expected our FTE levels to be and what that level really was.

(Slide)

To address that gap, FDA and industry negotiated an agreement that will provide FDA a total of $98,000,000 over 5 years. Moreover, unlike the original ADUFA, this reauthorization has inflation built in from the front end, better reflecting what we think are our true costs.

(Slide)

We further maintain the workload adjustment from ADUFA, again to better assure the program’s sound financial footing.

(Slide)

We also continued the revenue stream through the four fee types.

(Slide)

The only addition -- we also continue the triggers from ADUFA, assuring industry that we will continue to invest appropriated dollars in the review process.

We also changed the date for calculating adjustments from April to October so that the President’s budget would contain the final numbers for the ADUFA.

(Slide)

Then, based on our experience with ADUFA, we modified the legislation to delay offset collections until the final year, further minimizing the risk of the ADUFA program not having sufficient resources.

Also, we changed the fee rate for combination applications from a full application fee rate to one-half of a full application rate.

(Slide)

In closing, we believe the agreement we have ratified with industry will enable the FDA to sustain and even build on the success of the original ADUFA program.

Thank you.

MS. SINDELAR: Thank you very much, Gary.


Our next speaker is Dr. Steve Vaughn, and can you put up his slides for me? Thank you.

Performance Goals

by Steven D. Vaughn, D.V.M.

DR. VAUGHN: Good afternoon. My name is Steve Vaughn. I am the Director of the Office of New Animal Drug Evaluation here in the Center for Veterinary Medicine. I want to take you through in the next few minutes the -- at a fairly high level the performance goals that we have agreed to out of the negotiations that we have had with the regulated industry.

(Slide)

First and foremost, a little bit of background.

In ADUFA I, we were measuring sentinel

submissions -- and some of you may not be familiar what those are. In our new animal drug evaluation process, we have over 60 different types of submissions, and it would be administratively very cumbersome to try to measure performance on all 60 different kinds of submissions.

So what we had done in ADUFA I is we had chosen 6 sentinel submissions that would become the metrics, if you will, or the points of measurement, that would determine our overall performance rate in being able to measure the time frames it takes to complete those sentinel submissions.

We work in a particular queue that is established by the due date of each submission, and the sentinel submissions then would be scattered throughout any individual reviewer’s or team’s queue and as they move forward in a certain time frame, then that would indicate that that the entire queue is moving in a particular time frame. So it gives us an indication that our review times and thereby our performance is meeting the standards that were established in ADUFA I.

So what we are doing in ADUFA II is maintaining the same time frames that we currently have in our fifth year of ADUFA I. Our FY ’08 goals remain the same across ADUFA II.

What we have added to this process is what we are calling an “end review amendment process.” And let me explain that in the next couple of slides.

(Slide)

Essentially right now, if we get to the end of a review, there are two outcomes. One is an approval letter, or a complete letter, and the other is an incomplete letter, meaning there are deficiencies that need to be corrected.

With the end amendment review process, we will have those first two options plus a third option, and that third option basically says that there are some things wrong this submission, some deficiencies, but they are not overwhelming and they can be corrected through -- if we had just a little bit more time to complete them. And then we could ultimately get to a complete submission in one review cycle and not have to send an incomplete letter, wait for a response from the sponsor, and then go into a second cycle.

So this end review amendment process is envisioned to be able to complete a review in much shorter time than it would be for two cycles of review and hopefully move us in the direction that I think we all want to go, and that is one cycle review.

(Slide)

So the process basically begins is we do -- we receive a submission and we do our review, and we reach a time frame which is the same as the FY ’08 sentinel goal time frames, and we have one of three outcomes, and those are listed there.

We can either say the submission is complete, we have accepted it. There could be an approval letter if it is for a new animal drug application.

It may be an incomplete letter if there are a lot of deficiencies or the scope of the deficiencies are so large that we can’t engage this end review amendment process.

Then third outcome, then, is to engage the end review amendment process.

Then basically what happens in this process the end review amendment and then within a specified time frame, the sponsor of the application or submission will then provide us with that amendment. We will immediately review that amendment, and then we will provide one of two outcomes, either the complete or approval letter or an incomplete letter.

Now, this applies to certain types of submissions, and those include our original new animal drug applications. And you see under that “A & E,” those are the submission codes. And “A” is an original, first time an application is filed, and “E” is a reactivation -- if it comes back in after an incomplete letter, then it is an “E.” So that is what that means.

The second is for supplemental new animal drug applications that involve safety and effectiveness data, and the “C&R” are the codes that are similar to the “A & E” codes for the originals.

For INAD protocols, we have this process, and also for the INAD data submissions.

So, for those four types of submissions, we will engage the end review amendment process. And you can see the time frames that go along with each of those submissions there in the chart. So basically we -- our performance goal for a complete or incomplete is listed, followed by if we engage the ERA process, what the request date is, when -- the next column is when the submission has to be returned by the sponsor, what the goal would be if the sponsor doesn’t provide a submission for one reason or another, and what the goal is when they do.

And all of these time frames have to be met 90 percent of the time, or greater.

(Slide)

We also went into some other areas where we saw we could make some improvements in the evaluation process, and one was dealing with pre-approval inspections for GMPs or manufacturing facilities.

One of the things that developed over ADUFA I, the five-year period of ADUFA I, was that we started to develop a backlog mainly as a -- it was a resource issue of being able to conduct foreign inspections, getting to those foreign manufacturing sites and getting them inspected in a timely manner.

So we have done a number of things. We have gone to a risk base approach. We have worked collaboratively with the industry in trying to work out a system that will enable us to be able to request inspections earlier and to target inspections sooner so that we can have those foreign inspections completed prior to the time of approval without delaying approvals.

So, to that end, we have, as part of our goals that we have agreed to, that the sponsors can submit to us on an annual basis a facilities list. It is a list of facilities that they think over the next 12-month period might be subject to an inspection because they are working on application and they are in the development process somewhere and they would need to have that facility inspected. That way, we can notify our field investigators and get those things tentatively on an inspection list.

When we do our inspections in the field, it might help to add, when we do foreign inspections and we send someone to another continent, we try to get as most out of that trip as possible. So what -- if we have someone, for example, going to Europe, and there are five or six facilities in the same proximate area, we are going to have them inspect all those facilities while they are there and then come home. And so by having this annual list, it gives us a little bit of information that helps us to do that kind of planning, to make our resources go farther.

Then, the second part of this is there is a 30-day notification, and 30 days prior to the submission of what we believe will be the last chemistry and manufacturing piece which would have an 180-day clock on it or 180 days still to do, the sponsor would notify us that this submission is coming in and we can start the actual scheduling of that particular inspection.

(Slide)

In another arena, we have a number of issues where we want to -- scientific and administrative issues that we need to have more time to be able to communicate back and forth with the industry, to have discussions, to bring in scientific and academic folks and to talk about issue that pertain specifically to evaluating the safety and effectiveness of new animal drugs.

So in order for us to do that and for us to be -- to have the more in depth discussions and understanding of different perspectives, we have agreed that between the beginning of ADUFA II, which, if passed, will be October 1 of 2008, and the end of FY 2013, that we will have 10 public workshops that will be on topics that both the industry and CVM agree upon.

(Slide)

We also are moving into the 21 st century finally and we are trying to work toward paperless submissions and to do our review without paper. And so we are moving into an electronic environment. And part of this is our agreement that we will develop an electronic submission tool for industry submissions that is for on line review capability and we will do this within 24 months of receiving appropriated ADUFA funds.

(Slide)

We also have some other things that we will be doing -- exploring, discussing, and continuing our dialogue with the industry to continue to try to enhance our evaluation process. And here are four of the statements that we put into the goals letter that we think are important to further those discussions.

First, is to explore and discuss the applicable use of pharmacokinetic and pharmacodynamic data. This is valuable, new and emerging scientific data, or approaches to evaluation that we think has an opportunity for us to greatly expand and improve the way we go about looking at safety and effectiveness over the traditional clinical animal studies and large field trials and so on. So we are -- we have already actually started discussing these things and we want to continue those discussions.

We want to explore opportunities for exchange of information regarding the characteristics of a new animal drug.

One of the things that we believe that will help us to work on reducing the time to approval is sharing information about the characteristics of a new animal drug as early as possible in the process, and so we are looking for those opportunities early on for us to know as much about that drug as we possibly can, and looking for those opportunities for exchanging that information is one of the goals that we believe will enhance the evaluation process.

We are also always looking for ways to do things a little differently, a little bit smarter, and to that end that would result in shorter time frames for development and if safe and effective approval of these new animal drugs.

We want to use both formal and informal means of communication, whether meetings or other media, to insure that we have high submission quality.

Sometimes a submission comes in and there -- depending on which company we are working with, there is more or less communication during the review time, and we have found that the more high-level communication that occurs during the evaluation of a submission whether it be answering a reviewer’s questions or providing additional supporting information, those high-level interactions improve the quality of our ability to do the review and ultimately give us the greatest understanding about the safety and effectiveness of that new animal drug. So we want to take advantage of those opportunities.

With that, that is the overview of the performance goals that we have agreed to through our negotiations.

Public Comment

MS. SINDELAR: Thank you, Steve. This is the open public hearing portion of the meeting, and we will begin this session with the registered speakers. Following the registered speakers, we welcome additional comments from the floor.

Please remember the following for the purposes of transcription. First, speak clearly into the microphone when you are delivering your comments. Second, remember to identify your name and affiliation. And, third, if you have any written materials which you are using as a reference and/or PowerPoints, please provide them to the transcriber following the meeting.

So let us get started with our first registered speaker. It is my pleasure to welcome Dr. Richard Carnevale from the Animal Health Institute.

Public Comment

by Richard A. Carnevale, V.M.D.

DR. CARNEVALE: Thank you very much. My name is Dr. Richard Carnevale, and I am with the Animal Health Institute, Vice President for Scientific and Regulatory Affairs and some other things. I appreciate the opportunity to come here today and to make some very brief comments from AHI’s perspective on the new agreement that was reached between AHI and CVM.

(Slide)

I led the negotiating team that put the agreement together. Last year, about spring, I guess late winter, early spring, an AHI team was put together of company representatives and AHI staff. The companies were representing virtually all of the companies that are members of the Animal Health Institute. We are the only trade association that represents the research and development companies, and most of those companies are global.

We put a team together of 7 or 8 company representatives and AHI staff to take a look at ADUFA I, see how it was working, see what was good about it, what might need some improvement, and what we would like to see moving forward into the next round of ADUFA as far as enhancements, as far as things that we could do better, things that we would like to ask CVM to improve upon or to add to the program.

The ADUFA I agreement, I think, as Dr. Vaughn mentioned, was basically one of sentinel submission review times, and that is where it really ended, beyond some other provisions for protocols. So we wanted to see what more we could do with the review process.

So we entered into the negotiations with CVM last summer and that lasted approximately three months. It took all of our summer vacations. But we enjoyed it. We met every other week. And by the end of that three months, we reached consensus, by the last week of August, as a matter of fact, if I remember correctly. We finally came to agreement and shook hands, and said we have an agreement that we were all happy with.

It was a lot of hard work and we put a lot of time into it and I think there was very good cooperation between both sides of the table. You know, we didn’t agree on everything, but we certainly did come to an agreement on the major things.

The AHI board in September, at our Board meeting, ratified the agreement. So the agreement was set by AHI and it was up to CVM then to carry it through and get approval from the Department and the Administration. And they have since, obviously, done that.

(Slide)

Now, what were the -- missed it. What was the goal of the industry in moving into the next round of ADUFA? Well, I think Dr. Vaughn mentioned that our key goal was to reduce the overall time to approval of safe and effective products while maintaining current pre-approval standards for safety and efficacy.

I want to emphasize that several times today, that this ADUFA agreement, as the ADUFA I agreement, does nothing to reduce any requirements that FDA might feel is necessary to prove the safety and efficacy. It simply tries to get at issues of timeliness, efficiency and communication, I think to put it in three bullet points.

Pre-approval standards are still strong, they are still robust, and everything that CVM has to require to approve to assure safety and efficacy are still there, regardless of the ADUFA agreement.

(Slide)

What were some of the objectives under that goal? Well, we needed to certainly maintain or improve the performance standards for the key sentinel application submissions, as Dr. Vaughn mentioned. We would like to improve upon them, but at least maintain them, and as it turned out, we did maintain them at 2008 standards.

A very key part of the negotiations was the review cycles, which Dr. Vaughn mentioned. We wanted to reduce those number of review cycles, particularly for INAD protocols which were a particular problem in getting acceptance on, but also study submissions. There were many studies that would go through -- submissions that would go through multiple cycles, so a goal here was to reduce those number of review cycles.

(Slide)

Reduce delays in pre-approval foreign manufacturing site inspections. Again, Dr. Vaughn mentioned this. Those pre-approval inspections were pending years, in some cases. So it was significantly delaying the movement of the applications through the process because until you have a pre-approval inspection scheduled and done and everything accepted at that site, the application can go nowhere.

We certainly wanted to enhance communications with CVM so that the AHI companies and sponsors could better understand and respond to Agency requirements. This is obviously a very important thing to know what exactly the Agency needs. These are very complicated, technical submissions and protocols have a lot of elements to them. So trying to get better communications between the Agency and the sponsors is critical. So that was a key objective.

And of course we did want to continue to support the CVM funding so that CVM keeps conducting a high-quality and scientifically sound review process. We recognized that the costs were probably going to increase in order to continue that funding, and as we worked through the program, we realized that costs were increased somewhat higher than we expected, but we think we have negotiated a good agreement.

(Slide)

What was our experience with ADUFA I? Well, the backlog of overdue submissions were eliminated very rapidly. That was one of the keys in ADUFA I, is to get at that backlog that had been pending more than two years, and try to get that done. And CVM, to their credit, conducted that process and got that backlog done in very short order.

Certainly, the time frames for all the key sentinel submissions have been uniformly met. The reports that have come out every year have indicated that, so there is predictability back in the process. And this will in turn stimulate industry confidence in pursuing new research and development products.

The biggest obstacle to a company developing a product is knowing when things are going to be done. They have a lot of money invested in a research project, and knowing when those elements are going to progress through the stage of development is critical.

Knowing when FDA is going to review and render a decision on a particular submission or protocol or data package is critical, and there was very little predictability before ADUFA I. I think we have restored predictability to the process, and that is important for a smoothly flowing drug development.

(Slide)

The additional CVM staff that has been added has certainly provided more opportunities for improved communications between the review staff and sponsors and this has certainly led to a better understanding of requirements, but we continue to work on that because communication, as we all know, is a difficult thing to do in any organization.

Those improved communications between industry and ONAED I think has in fact resulted in ADUFA I in reducing some of those review cycles, even though we are going to work very hard in ADUFA II setting up those specific procedures that Dr. Vaughn mentioned to really get at trying to get down to that goal of one cycle review. I think we have made some progress, though, ADUFA I.

(Slide)

So, in summary, we certainly support the proposed agreement that was presented today by FDA. We recognize that the costs -- our members recognize that the costs of ADUFA II have increased significantly, but we also understand that it is necessary for CVM to maintain their current stable and effective work force and to get the job done and get those standards met in the goals getting products out to the marketplace.

ADUFA II benefits not only sponsors, veterinarians and animal owners, but we believe also the general public by insuring that a rigorous approval process protective of public health is in place.

(Slide)

Currently, animal health products can take 7 to 10 years at costs of $100,000,000 or more. Key provisions in ADUFA II such as the end review amendments, that will further reduce the number of submission review cycles. Reduction in those review cycles on sentinel submissions can reduce the time for safe and effective products to get to veterinarians and animal producers.

So, again, the goal that we started out with we think we will meet in ADUFA II. That is to reduce the overall time to approval of products that FDA deems safe and effective.

(Slide)

Again, emphasize the agreement does not reduce any pre-approval animal or human food safety requirements. And with regard to safety, it is also important to emphasize that through a robust approval process, FDA takes into account safety throughout the life cycle of the product, not just at the beginning but throughout the whole time that product is on the market.

Animal safety, human safety -- certainly, there has been more recent requirement for assessing the antimicrobial resistance of antimicrobial products. Environmental safety is a key component of the evaluation. And drug experience reports and adverse reaction evaluations when the product is on the market.

So there is safety that is evaluated throughout the entire life cycle of the product.

(Slide)

We look forward to working with FDA to achieve Congressional reauthorization of ADUFA.

It is going to be a challenge this year because of the election year, I am sure, but I know that we are up to the task of getting it passed and passed into law by October.

Building on the success of ADUFA I will lead to a more vibrant industry and more effective regulatory agency benefiting animal and human health.

Thank you for the opportunity to comment.

MS. SINDELAR: Thank you, Richard.


Our next registered speaker is Brise Tencer, representing the Food and Environment of the Union of Concerned Scientists.

Public Comment

by Brise Tencer

MS. TENCER: Great. Thank you. My name is Brise Tencer, and I am the Washington Representative for the Food and Environment Program at the Union of Concerned Scientists. We are a member of the Keep Antibiotics Working Coalition, and I am actually here today to present some brief comments on behalf of the Keep Antibiotics Working Coalition.

As I said, my comments are going to be brief, but we will be trying to submit some more detailed comments in writing by the April deadline.

The Keep Antibiotics Working Coalition really appreciates this opportunity to provide comments on the proposed recommendation for the reauthorization of the Animal Drug User Fee Act of 2003.

The Keep Antibiotics Working Coalition is a group of health, consumer, agricultural, environmental, humane and other advocacy groups with more than 9,000,000 members dedicated to eliminating a major cause of antibiotic resistance, that being the inappropriate use of antibiotics in food animals.

KAW believes that ADUFA has a significant impact on the ability of the Federal government to respond to the threat of antimicrobial resistance related to antibiotic use in food animals.

The Keep Antibiotics Working group opposes ADUFA reauthorization and the proposed recommendations because ADUFA distorts the priorities of the FDA which respect to new animal drugs by shifting the emphasis from protecting public health to efficiently approving new animal drugs.

Tying funding for the Center for Veterinary Medicine to goals related to drug approvals without simultaneously setting goals relating to improving the protection of public health is a prescription for disaster.

We oppose the reauthorization, but if it is to go forward, then funding for goals related to protection of public health must be included in the reauthorization.

When the Prescription Drug User Fee Act was reauthorized, specific goals related to post-market drug safety were included. Similar goals related to post-market drug safety should be part of any reauthorization of the Animal Drug User Fee Act.

Antimicrobial resistance is the greatest public health risk related to use of veterinary drugs in animals under the current regulatory regimes, according to the World Health Organization. Because of this, post-market drug safety improvements should focus on managing the risk of antimicrobial resistance.

ADUFA funds should be allocated for:

One, antimicrobial resistance safety reviews of existing antimicrobial approvals.

Two, collection of veterinary drug use data to support antimicrobial resistance, risk management and assessment.

Three, resistance surveillance including the National Microbial Resistance Surveillance System and surveillance of agricultural related Methicillin Resistance Staphylococcus Aureas.

Along with additional funds for the three areas described above, there should be performance goals set from improvements in these areas of post-market drug safety.

In addition, to insurance transparency and public confidence in the veterinary drug safety system, the FDA should make public complete drug safety information related to antimicrobial resistance, not the very limited information currently available in Freedom of Information summaries.

The Keep Antibiotics Working Coalition asks that the current ADUFA recommendations be modified to incorporate these suggestions. We hope that you will take these comments seriously.

The February 21 st, 2008 Federal Register notice announcing this public meeting we believe distorts what occurred at the April 24 th, 2007, meeting when it states that “There is general agreement among the responding stakeholders that ADUFA should be reauthorized.”

Two of four presenters opposed reauthorization and one expressed serious reservations. In essence, there was little support for reauthorization except from a single stakeholder. The current recommendations reflect in no way the concerns raised by one of our members of the Keep Antibiotics Working Coalition from the Food Animal Concerns Trust at that meeting.

The Center for Veterinary Medicine should follow its mission statement and put consumer protection first. We oppose reauthorization, but if reauthorization is going to happen, funds need to be used for consumer protection. This means putting in place the post-market drug safety enhancements as outlined previously.

We will submit more detail on those recommendations.

Thank you.

MS. SINDELAR: Thank you, Brise. Our last registered speaker is Barbara Determan, who will be speaking for the National Pork Council.


Public Comment

by Barbara Determan

MS. DETERMAN: Thank you. I am Barbara Determan of the Security Policy Committee for the National Pork Producers Council. And I am here today to tell you, on behalf of America’s pork producers, and thank you for the opportunity to comment on the Animal Drug User Fee Act, or ADUFA.

When ADUFA was signed into law, the pork industry supported that legislation, which represented the agreement negotiated between the animal health industry and the Food and Drug Administration’s Center for Veterinary Medicine.

We again support the agreement between these industries and CVM. We would request that the legislative language reflect this agreement.

Our industry has faced a number of disease challenges since ADUFA was first signed into law. ADUFA I helped the pork industry by bringing three new swine health products to the marketplace. These new medicines help U.S. pork producers handle significant health challenges.

ADUFA was able to get the new, innovative technologies that we needed on our farms which has helped our industry to grow and prosper.

The pork industry is not the only industry that has benefited from ADUFA. Last year alone, veterinarians and pet owners received nine new products to help pets live longer, healthier lives.

This clearly illustrates that ADUFA is working and that the current process achieves the goal of delivering new products to animals that need them.

The pork industry also realizes that bringing new products to the marketplace is extremely expensive for the animal health industry. We also realize that the user fees add to the financial burden.

However, we believe that these additional fees in ADUFA II will greatly benefit not only the animal health industry but also livestock and pet owners.

Enabling the FDA to maintain its high standards of safety and effectiveness for animal drugs is extremely to us, as pork producers. We strive to provide safe and healthy pork to both the global marketplace and our own American family tables.

Pork producers need to know that all FDA-approved products are safe for our animals, our environment and our consumers. ADUFA helps provide the resources to give all producers that assurance.

As a pork producer, I am concerned when a new or an emerging disease breaks out. When my pigs suffer from a disease, it is devastating.

The new and emerging diseases that we see today are very challenging. New technologies and products are often needed to get ahead of these new diseases.

ADUFA assures that animal health companies are able to provide all animals with the products to treat and control the new diseases that we may face.

While new and emerging diseases are a worry, preventing diseases that have also plagued the industry for years is an ongoing challenge. ADUFA insures that we have animal health products that allow me to work with my vet to keep my animals healthy, and that is, prevent them from getting sick, as the need to treat disease sometimes is often -- is sometimes viewed by a vet as a failure in prevention.

Another benefit of the animal health innovations prompted by ADUFA is improved animal well-being. So we would strongly urge that ADUFA II be adopted.

Our industry is also looking for solutions to insure the United States continues to have the safest meat supply in the world. The animal health industry needs to help the pork industry conquer food safety challenges by investing in new medicines and technologies. Producers cannot do this alone.

We need new and innovative medicines to maintain the health of our pigs and deliver safe, wholesome meat products to our consumers around the world.

As a pork producer, I have a responsibility to protect public health, animal health and food safety. This is a responsibility that we as America’s pork producers share with the FDA. We do want to protect human health by insuring animal health.

Pork producers need new medicines and technologies to accomplish this. The broader public interest is served when pork producers have the means necessary to keep their animals healthy. ADUFA is a critical tool needed by our industry and our veterinarians.

We thank you once again for the opportunity to comment on this important agreement, and we will be providing written comments later.


Introduction

by Aleta Sindelar, Moderator

MS. SINDELAR: Thank you. And this completes our comments from our registered speakers. And so now we may open the floor for comments for those who have attended but did not register. And if you would just use the mike, please feel free to make your comment.

(No response)

Well, if we have no more comments, no additional opinions to be expressed from those in attendance --

I would like to remind you that the comments may be made -- additional comments may be made to the docket and the docket is Docket No. FDA 2008N0082. Comments must be submitted by close of business April 14 th, 2008.

So without further ado, this concludes the meeting, and we thank you all for your participation and your thoughtfulness in attending the meeting.

(Whereupon the meeting was adjourned at 1:54 p.m.)