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4 FDA/CENTER FOR VETERINARY MEDICINE
5 STAKEHOLDER MEETING
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9 April 28, 1998
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14 Johnson County Community College
15 Overland Park, Kansas
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1 MR. ROGERS: To start our afternoon
2 session Dr. Sundlof, the Director for the Center
3 for Veterinary Medicine, is going to give us an
4 update. His colleague, Dr. Tollefson will sit in
5 for him and tell us what has happened since our
6 last stakeholder meeting in August. And now to
7 launch us for this afternoon's session,
8 Dr. Sundlof.
9 DR. SUNDLOF: Thank you, Mike.
10 And I do apologize for being late this morning, but
11 I think it was very ably handled.
12 We will go ahead and talk just a
13 little bit about some of the things -- some of the
14 problems that we face at the CVM.
15 Although we're trying very hard to
16 meet people's expectations, sometimes it's a little
17 bit difficult.
18 Here's kind of the problem. We
19 showed a similar slide at the last stakeholders'
20 meeting, and at least to date nothing much has
21 changed. In the last five years, as Dr. Henney
22 mentioned, the FDA in general has had an eroding
23 base budget, even though the numbers have stayed
24 the same or even increased in some areas at least a
25 little bit, certainly in the area of user fees
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1 there's been a change in the resources available to
2 the agency. That's not the case at CVM.
3 We have had some increases in food
4 safety issues, but that's very targeted and
5 focused. So we do have decreasing resources in the
6 face of expanding responsibilities. And there are
7 a number of those.
8 Just to list some of the areas
9 where we're at, we've had no program increases in
10 nonfood safety initiative programs in the '90s.
11 There's been no increase for inflation, pay raises
12 or cost of living from '92 to '99. We've had no
13 pay increases in cost of living. That comes out of
14 our operation budget. So we have less money to
15 hire new people in such activities as standards and
16 new development, regulation-writing, et cetera.
17 We've had to absorb reductions to cover tobacco,
18 and food safety initiatives in 1998. And the way
19 that worked was we asked in our budget for certain
20 amount of money; and in the case of tobacco it was
21 about $34 million to put tobacco programs together
22 that we were appropriated $16 million but told to
23 spend $3 million dollars. So that additional $17
24 million -- or whatever it comes out to be -- $20
25 million, $18 million came out of all of the
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1 programs within FDA.
2 As a result of the present
3 streamlining initiative, the national performance
4 review we've had to downsize and streamline some of
5 our processes. And in addition, we've had to take
6 on some new legislative initiatives which we fully
7 support and we're very glad that we did have
8 success in getting legislation. But along with
9 that legislation is a demand that we do a lot of
10 work to implement the right regulations and et
11 cetera, and that takes away from some of our more
12 core functions.
13 Here's what we've asked for in the
14 year 2000. As Dr. Henney said in her program, this
15 is the biggest increase that the FDA has ever asked
16 for, and if we're successful, we will be very
17 grateful. This will help to restore some of the
18 erosion that has occurred in the '90s. If we are
19 successful in what we've asked for -- and the
20 President has already supported this -- there will
21 be an additional 36 positions in the Office of New
22 Animal Drug Evaluation to help us with some of the
23 backlog and in the regulation-writing process.
24 We also will ask for about $4
25 million in operating costs for the agency, which
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1 would give us a total of a little bit over $7
2 million, and that doesn't include the increases to
3 the field. That would be substantial in CVM's
4 base budget.
5 Here's what we identified in the
6 year 2000 as some of the gaps. And if you look at
7 this chart, the entire bar is where we think we
8 ought to be. This is what we would need to do our
9 job as we think expectations are out there. A lot
10 of this is based on our last stakeholders meeting
11 where people told us where we should be spending
12 our resources, the things that we're supposed to be
13 doing.
14 You can see that the green area is
15 what we're presently able to do. If we get our
16 year 2000 increase, that's what the red bar is. So
17 even with an increase in people and money, it
18 doesn't make a lot of impact on our overall ability
19 to reach our goal of a hundred percent.
20 Premarket Approval. Again that's
21 an area where we want to focus a lot of our
22 resources.
23 Product Quality Assurance. That's
24 making sure that we are inspecting, making sure
25 that we're out there in the plants and doing our
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1 job in a timely manner so that we're making it once
2 every two years.
3 Our research will actually
4 decrease a little bit in 2000. But research is in
5 fairly good shape presently and that's largely due
6 to the Food Safety Initiative.
7 Outreach, our ability to
8 communicate with our stakeholders, is important,
9 and we will not be doing as much next year as we
10 were doing this year.
11 Enforcement. Again, an area that
12 is suffering because of the erosion of our base.
13 Injury Reporting. Although in
14 2000 we are asking for $800,000 to do a better job
15 of injury reporting or event reporting, some of
16 these areas where you see we're actually going
17 down, it was planned that we would ask for
18 increases in those areas in the year 2001. So if
19 we are successful this year, in our budget for 2001
20 we'll try and make up for some of those losses this
21 year.
22 Well, in -- based on the chart
23 that I just showed you, those are just the things
24 that are -- those are the products that FDA/CVM
25 produces.
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1 The whole budget was targeted at
2 productivity, but it didn't really take into
3 account many of the things that Dr. Henney has just
4 talked about, and especially improving the science
5 base of the organization. And so we're going to
6 have to address that also in our year 2000 budget.
7 I'll talk a little bit about why I
8 think improving the science base is very
9 important. I fully support what Dr. Henney's
10 vision is for improving the science base.
11 This is kind of a schematic that I
12 came up with, and that's about as complex as can I
13 get it, drawing a triangle. This is supposed to be
14 a pyramid in which the base of the pyramid is the
15 science, and the science is the support of most of
16 our regulatory activities, all of the standard-
17 setting, et cetera, et cetera. When you have a
18 fairly minimal science base, you have a very large
19 regulatory oversight.
20 The caption says, "In the Face of
21 Uncertainty FDA Will Over-Regulate Every Time."
22 And that's fairly true. I found that to be very
23 consistent that with imperfect knowledge where
24 there is uncertainty, the FDA and other regulatory
25 agencies -- especially public health agencies --
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1 will always take a conservative approach, because
2 they are accountable. Those agencies are
3 accountable. But the better the information, the
4 more surgical, the more precise those regulations
5 can be so that they are less burdensome to the
6 industry.
7 We look at the science base.
8 Again, the white part of that schematic represents
9 the science base with the regulatory oversight
10 being the top part. Where we'd like to get to is
11 to have a relatively small oversight that draws
12 from a very large scientific base.
13 I put surveillance on the bottom
14 because I think surveillance is critically
15 important to our ability to write correct
16 regulations and have feedback as to if the things
17 that we've done in terms of standard-setting,
18 regulations are providing the results that we
19 anticipate.
20 Surveillance is very important
21 from the standpoint of things that we don't know.
22 We really look at surveillance as an activity where
23 we're casting a broad net out there and we're
24 trying to find out information, burdening our
25 regulated products that we may not have any idea
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1 exists out there.
2 We require fairly indepth clinical
3 studies before we approve a drug, but things happen
4 that were never anticipated. This happens in
5 veterinary products; it also happens widely in
6 human products. Without a good surveillance
7 program out there -- and I think some of the
8 questions that you just heard in the telecast
9 really supported that -- how can we get information
10 back to the FDA that we're having problems with
11 certain products? Having a good surveillance
12 program out there that's sensitive and picking up
13 critical information that we can feed back into the
14 regulatory process is very important because we
15 just don't know everything.
16 In the face of ignorance we will
17 tend to underregulate, and that's not good either.
18 Research is a second component.
19 Research will provide answers to questions that we
20 know to ask. If we know that we need more
21 information in a specific area, we can use research
22 to provide us with those answers. This doesn't
23 mean that all of the research and all of the
24 surveillance is the responsibility of FDA. In
25 fact, most of the research -- actually only a very
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1 small part of the research that we use in our
2 decision-making process and standard-setting
3 process comes directly from FDA research. We draw
4 from the full scientific body of knowledge out
5 there.
6 Similarly, although a lot of our
7 activities, because they are product-related in
8 terms of surveillance, are related to FDA-based
9 surveillance, there are other surveillance systems
10 out there, too, such as Centers for Disease
11 Control, MedWatch and other things that are funded
12 by FDA will add to that surveillance information
13 that we need.
14 Then the most important thing that
15 I think we do as a regulatory agency is set
16 standards that are reasonable, that are protective
17 of the public, that are not overly burdensome on
18 the regulated industry. Standard-setting is a very
19 public process. We set standards that we think
20 conform with what society expects from us. That's
21 why it is an open process. But once we set those
22 standards, then it's up to us to help the
23 industries meet those standards. So we want to set
24 standards that are focused, that are not overly
25 burdensome, but that are protective of the public
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1 health and then help the industries meet those
2 standards.
3 The last two things on the top of
4 that that aren't labeled up there: Enforcement and
5 Approval. Those are the two regulatory actions
6 that we generally take -- as FDA is we approve
7 products and we take regulatory action against
8 products that don't come into compliance with the
9 standards.
10 So now this is a chart that you
11 already saw where we just talked about improving
12 our capacity to do the things to make the outputs
13 that we have generally. What are we going to need
14 in the year 2001 in order to not only improve our
15 ability to meet our statutory requirements but also
16 to improve the science base. We're in the process
17 of working on that budget right now. But certainly
18 trying to keep people current, making sure that the
19 scientists and the FDA are on par, have parity with
20 the scientists in the industries that we regulate,
21 et cetera.
22 I think I'll just stop right
23 there. Thank you.
24 MR. ROGERS: Thank you, Steve.
25 A couple of ground rules for our
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1 stakeholders session this afternoon. I'm going to
2 ask each of the speakers to please identify
3 yourselves before you start speaking, for the
4 benefit of our transcriber. You will each have two
5 minutes -- I'm sorry -- ten minutes; except the
6 National Pork Producers, Paul and Beth, will have
7 five minutes each. But two minutes.
8 I am going to introduce my black
9 belt karate member of our compliance group, Noel
10 Ferguson. He is black belt, and I brought him
11 along to be sure that we adhere to the time limits
12 of ten minutes.
13 All right. Our FDA panel is not
14 to engage in debate but to clarify questions as
15 appropriate.
16 You might also notice that at
17 about 4:30 we will be inviting statements,
18 questions from the audience. The microphones are
19 on the side of the aisles and are provided for that
20 purpose.
21 So with no further ado, Panel No.
22 1, starting with Dr. Swanson.
23 DR. SWANSON: Dr. Richard Swanson.
24 I'm president of the American Veterinary Medical
25 Association.
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1 Good afternoon to all of you.
2 It's good to see you. And thanks for eventually
3 showing up, Steve.
4 As president of the American
5 Veterinary Medicine Association I am pleased to
6 participate in the stakeholders meeting. These
7 issues are near and dear to the AVMA's heart, as
8 drug availability is directly related to the
9 veterinarian's ability relieve the pain and
10 suffering of animals.
11 The objective of the AVMA is to
12 advance the science and art of veterinary medicine,
13 including the relationship to public health,
14 biological science and agriculture. The
15 Association provides a forum for the discussion of
16 issues of importance to the veterinary profession
17 and for the development of official positions. The
18 Association is the authorized voice of the
19 profession in presenting the views to government,
20 academia, agriculture, pet owners, the media, and
21 other concerned public.
22 The FDA seeks input on the animal
23 Drug Availability Act and how to strengthen the
24 Agency's science base and improve the communication
25 processes. With regard to the ADAA, areas of
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1 progress have included the definition of "adequate
2 and well-controlled study," approval of one
3 veterinary Feed Directive product, though no
4 regulations, feed mill licensure, approval of
5 combination products and the CVM's minor use minor
6 species proposal. The determination of
7 "substantial evidence" of efficacy is a big piece
8 of the ADAA that is still being tracked; that is,
9 determining when greater one adequate and
10 well-controlled study is needed or when field
11 studies are needed to establish efficacy. It is
12 through this piece that the AVMA and others seek a
13 speedier drug approval process.
14 With respect to the FDA's desire
15 to strengthen the science base and improve its
16 communication processes, let me offer the AVMA's
17 replies to Questions 1, 2, and 5.
18 Question No. 1 asks what actions
19 the agency might take to expand FDA's capability to
20 include state-of-the-art science into its
21 risk-based decision-making. The AVMA applauds
22 science and risk-based decision-making, and it is
23 apparent that the CVM's concern with the approval
24 requirements for antimicrobials for food-producing
25 animals is an obvious opportunity for CVM to apply
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1 these principles.
2 The agency has made it clear that
3 the approval of some new antimicrobials of high
4 public health concern for use in food-producing
5 animals will not proceed without the incorporation
6 of a framework to address the microbial safety
7 aspect of these products and a potential impact on
8 human health.
9 The AVMA is committed to working
10 closely, in cooperation, with the FDA/CVM on the
11 proposed framework. Nevertheless, the AVMA urges
12 two principles: First, that the agency consider
13 regulating microbial safety under the rules for
14 food contaminants instead of those for food
15 additives. Food contaminants are substances that
16 are unavoidably present and whose presence is
17 tolerated, while food additives are those
18 substances deliberately incorporated into foods.
19 Each of these categories clearly engender different
20 requirements.
21 Second, the AVMA advises that the
22 agency conduct a risk assessment to characterize
23 the actual human health impact of the use of
24 antimicrobials in food-producing animals and derive
25 the other benefits that a risk assessment offers.
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1 Risk assessment is well recognized
2 as a tool that supports decisions. The discipline
3 uses scientific data to evaluate risk and was
4 introduced in the 1970s to evaluate the human
5 cancer risk. Risk assessment provides what has
6 been called by Anna Lammerding of Health Canada, "a
7 common, unified work space for people of different
8 backgrounds to contribute to a better understanding
9 of the whole system." Risk assessments show where
10 there are data gaps, serve as a storage vehicle for
11 valuable knowledge as it is accumulated, and
12 describe a chain of cause-and-effect events where
13 proposed changes can be evaluated.
14 We recognize that this is an
15 onerous task and realize that many data gaps will
16 be revealed. But this tool puts us all on the same
17 page looking at the entire process.
18 Research needs to be elucidated
19 and can be prioritized, and as data is collected it
20 can be plugged into the many holes. Over time we
21 will have a more coherent understanding of the
22 human health impact of anti-microbial use in
23 food-producing animals. Forgive my oversimplified
24 comparison to 3,000 pieces of a jigsaw puzzle
25 spread out over a large table whereby a number of
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1 different people identify pieces and assemble these
2 pieces into distinct parts. Together these parts
3 are assembled to make the whole and complete
4 picture, visible to us all. I believe that example
5 illustrates in an admittedly simple way that the
6 benefits to all of us of conducting a risk
7 assessment. I believe the subject of
8 anti-microbial resistance and potential human
9 health impact is too important for us not to
10 prepare a risk assessment.
11 The second question seeks to
12 determine the ways the agency can facilitate the
13 exchange and integration of scientific information
14 to better enable FDA to meet its public health
15 responsibilities throughout a product's life cycle.
16 Antimicrobial use in
17 food-producing animals is, again, a fitting
18 example. The AVMA sees the value in the
19 establishment of a panel of experts, as described
20 in the Institute of Medicine/National Research
21 Council report "The Use of Drugs in Food Animals:
22 Benefits and Risks." In the report, the Committee
23 on Drug Use in Food Animals recommended that
24 further development and use of antibiotics in both
25 human medicine and food animal practices have
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1 oversight by an interdisciplinary panel of experts
2 composed of representatives of the veterinary and
3 animal health industry, the human medicine
4 community, consumer advocacy, the animal production
5 industry, research, epidemiology and the regulatory
6 agencies. The mission of this panel would be to
7 review on a scheduled basis data that address the
8 concerns of antibiotic resistance development in
9 animals and humans and to advise regulatory
10 agencies in the development and use of antibiotics
11 in agriculture and human medicine.
12 We would also suggest that FDA
13 foster a more cooperative relationship with the
14 USDA Agricultural Research Service and the
15 Cooperative State Research, Education and Extension
16 Service for scientific expertise and the USDA Food
17 Safety and Inspection Service in the conduct of the
18 microbial risk assessments.
19 Question No. 5 asks how to enhance
20 the communication process. Allow us to be
21 participants. We look forward to the active
22 involvement in planning the CVM's upcoming
23 workshops that pertain to the requirements posed in
24 the framework document, for example.
25 Let me also take this opportunity
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1 to compliment the CVM on some of their existing
2 means of communication; for example, on their
3 outstanding representation at the AVMA council and
4 committee meetings. This vehicle of communication
5 is effective and greatly appreciated by the AVMA.
6 I'm also pleased that the CVM
7 actively submits articles and information for
8 inclusion in the journal of the American Veterinary
9 Medical Association. The journal reaches 63,000
10 veterinarians, a very large portion -- in fact,
11 almost all -- of our profession.
12 We also find the FDA Veterinarian,
13 CVM Updates and CVM web site to be helpful.
14 In closing, the American
15 Veterinary Medical Association wishes to thank the
16 Center for Veterinary Medicine for this opportunity
17 to comment and looks forward to ongoing cooperation
18 with the Center. We thank the Center for
19 recognizing the role of the veterinarian as an
20 informed professional in the safe and effective
21 administration of drugs to animals. Such
22 recognition is apparent in CVM's assignment of
23 prescription or Veterinary Fed Directive status to
24 drugs, creation of regulations for extralabel drug
25 use, application of professional flexible labeling
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1 and the most recent acknowledgment of the AVMA
2 judicious antimicrobial use principles. We pledge
3 continued responsible drug use in the care of
4 animals and active participation in the many
5 deliberations that lie ahead.
6 Thank you very much.
7 (Applause.)
8 MR. ROGERS: Any questions from
9 the FDA?
10 (No response.)
11 MR. ROGERS: Dr. Carnevale.
12 DR. CARNEVALE: Thank you, Mike.
13 I can personally vouch for Steve.
14 He had a good excuse. I think we got on and off
15 that plane more times in one morning than I think
16 I've ever done in the last year.
17 In any case, thanks for inviting
18 us here to the stakeholders meeting. I am
19 Dr. Richard Carnevale of the Animal Health
20 Institute, Vice President for Scientific Regulatory
21 and International Affairs and on behalf of the
22 Animal Health Institute and the Coalition for
23 Animal Health I appreciate the opportunity to
24 discuss the challenges that face the Center for
25 Veterinary Medicine.
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1 As you know, AHI represents the
2 companies that research and develop the drugs and
3 vaccines that protect the health of both food and
4 companion animals. Today I plan to discuss the
5 overall effectiveness and operation of the drug
6 approval process, both as it pertains to the FDA
7 Modernization Act and the current efforts by CVM to
8 alter the existing process for review of
9 antibacterials. I will not address my comments to
10 the Animal Drug Availability Act. Joel
11 Brandenberger and Dave Bossman will specifically
12 address issues on ADAA later in the program.
13 As you are aware, AHI and the
14 members of the Coalition for Animal Health have
15 voiced strong concerns about CVM's proposed new
16 safety requirements for animal antibacterials
17 without having adequately assessed the actual risks
18 to public health. Dr. Swanson just addressed
19 similar comments in his presentation.
20 These concerns were addressed
21 directly in comments to the Veterinary Advisory
22 Committee and amplified in the AHI comments filed
23 on the proposed framework document in early April.
24 It continues to cause us concern that while the
25 Office of Epizootics and the World Health
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1 Organization, among other scientific bodies, have
2 continued to suggest that documented risk
3 assessment is the appropriate tool to develop and
4 refine policy for animal/human safety, however, we
5 fear that CVM may have established a zero risk
6 policy for this issue.
7 Throughout the debate on
8 antibiotic resistance, AHI has vocally supported
9 the collection of national data to provide a
10 meaningful overview of the prevalence of resistant
11 food-borne pathogens. Specifically we believe that
12 the National Antimicrobial Resistance Monitoring
13 System should be expanded to provide a more robust
14 picture of change in susceptibility. We look
15 forward to the opportunity to work directly with
16 USDA and FDA to improve and expand the NARMS
17 system. We believe that CVM shares our goals in
18 this area, and we also believe that within AHI and
19 the Coalition we have expertise that will be
20 valuable if utilized in a positive manner. We hope
21 CVM will take the opportunity to involve industry
22 in workshops and symposia on this and other key
23 elements of the effort to better understand the
24 potential for resistance development.
25 In fact, we are working to develop
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1 a workshop with CVM on the concept of resistance
2 thresholds that is broadly laid out and discussed
3 in the framework document. Again, while this is a
4 positive step, CVM must make every effort to make
5 sure that workshops and other efforts to get public
6 input allow balanced participation and open input.
7 We fear this was not the case in the VMAC hearing,
8 the only previous opportunity for scientific review
9 and public comment. In that case the format
10 narrowed the range of questions that VMAC Committee
11 members were allowed to pursue, and the public
12 comments in many instances seems to have been
13 overlooked. We certainly hope that CVM will
14 carefully review these and subsequent comments to
15 the framework document when preparing revisions.
16 All of the members of the
17 Coalition for Animal Health have been active
18 participants in the AVMA's association efforts to
19 develop judicious use guidelines. We believe those
20 efforts to combat the development of resistance are
21 a key part of meaningful strategies to protect
22 animal and human health.
23 We were somewhat disappointed when
24 the judicious use guidelines did not figure
25 prominently in the proposed framework or in the CVM
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1 presentation at VMAC. We would encourage CVM to
2 make judicious use guidelines the cornerstone of
3 the framework.
4 The member companies of AHI
5 believe that the approval process for animal drugs
6 should be based on science and the actual
7 assessment of risk and not on assumed risk.
8 Furthermore, the approval process should be certain
9 and predictable. In many ways the current approval
10 process at CVM fails to meet these standards. In
11 October 1998, AHI filed a Citizens Petition with
12 the Food and Drug Administration asking that CVM
13 refrain from imposing additional requirements on
14 individual applicants until the legal and
15 scientific justifications for these requirements
16 were clarified. We believe that the approval
17 process continues to be disrupted by the
18 uncertainty of these product-specific
19 requirements. AHI looks forward to CVM's review
20 and response to its petition.
21 AHI and the Coalition for Animal
22 Health have always been committed to working
23 constructively with CVM and attempting to address
24 issues of concern in a positive and proactive
25 manner. The record of cooperation with CVM
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1 established during development and passage of the
2 Animal Drug Availability Act is a testament to that
3 commitment. We believe that the spirit of
4 cooperation can and should be brought to the table
5 as the issue of antibiotic resistance is addressed.
6 With my remaining time, let me
7 turn my comments to the Food and Drug Modernization
8 Act. We would like to focus on five areas of that
9 legislation in regard to their impact on animal
10 drugs, impact and implementation.
11 Section 116, Manufacturing
12 Changes. We welcome the fact that congress and FDA
13 are moving to implement a more streamlined
14 procedure for making changes in the manufacturing
15 process and/or specifications of new human and
16 animal drugs, particularly for those changes
17 considered minor. However, we want to point out
18 the long before FDMA, AHI and CVM had worked out a
19 procedure for the agency review of Category I
20 manufacturing changes called the Alternate
21 Administrative Procedure. This allowed firms to
22 submit many changes considered minor as biennial
23 reports to the Agency, both expanding the current
24 list of changes that don't need prior approval and
25 also reducing the paperwork burden for documenting
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1 such changes. AHI co-sponsored a workshop with CVM
2 to introduce the procedure for the AAP. We viewed
3 this as a highly productive exercise with many of
4 our member firms participating in the program.
5 With passage of FDMA, our initial reading was that
6 the law should not change the basic tenets of the
7 AAP, but more recent feedback from the agency
8 indicates that may not be the case. In particular
9 Section 116 requires annual reporting while the AAP
10 permits biennial.
11 The major concern with our members
12 at this stage is that we're unable to get any
13 specific guidance from CVM on this issue. We hope
14 that the benefits gained from the AAP are not lost
15 because of the knew legislation.
16 Section 130, Reports of
17 Post-Market Approval. This is a new provision of
18 the law which requires reports of post-marketing
19 studies on new drugs and presumably new animal
20 drugs. AHI has several questions with regard to
21 the provision. What was the intent of this section
22 and how is it applicable to animal drugs? What
23 types of studies will it apply to? Could it
24 potentially apply to antibiotic resistance
25 monitoring, which may not be a study, per se, but
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1 the ongoing collection of data? We are also
2 concerned with the public release of such studies.
3 The law only indicates the identification of the
4 sponsor and the status of the study will be
5 released. Could that potentially be interpreted to
6 allow release to the public?
7 Finally will there be a lead
8 office for reporting the information to the public
9 or to Congress, or will each Center be
10 responsible?
11 Section 402, Expanded Access to
12 Investigational Therapies and Devices. An
13 important section or part of the law allows greater
14 access to lifesaving therapies that may not be
15 available commercially but are under investigation.
16 This is clearly aimed at human therapeutics, but
17 could it be applicable under similar circumstances
18 to animal drugs? CVM has a compassionate use
19 policy that permits the use of certain unapproved
20 drugs for treating animal diseases where there may
21 be no approved drug. However, this policy is tied
22 to the INAD in that the veterinarian wishing to use
23 the drug must be engaged in an active
24 investigation. Furthermore, it's uncertain whether
25 or not the company would be able to recover costs
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1 for providing the drug and must maintain specific
2 records of the distribution and use.
3 Companies frequently get requests
4 for investigational drugs that have data -- at
5 least partial data -- showing them to be safe and
6 effective, but they're just not yet approved. They
7 have a difficult time honoring those legitimate
8 requests unless they're able to assume the costs
9 and all the recordkeeping and other
10 responsibilities that go into it.
11 We'd encourage the Center to
12 consider to apply the intention of this section of
13 FDMA to animal drugs.
14 Approval of Supplemental
15 Applications for Approved Products under Section
16 403. This section covers new criteria for
17 supplemental applications. AHI would like to know
18 when guidance on implementing this provision would
19 be available for animal drug manufacturers. We
20 know that FDAMA encourages the companies to submit
21 supplemental applications based wholly or in part
22 on published literature or data already submitted
23 to prevent duplication of research. This does seem
24 at odds with the proposed regulation published last
25 year on the new definition of "substantial evidence
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1 of effectiveness" under the Animal Drug
2 Availability Act. In that proposal, the agency
3 appeared to be discouraging the use of public
4 literature as a demonstration of substantial
5 evidence as well as the previously submitted data
6 considered less than contemporary. We wonder how
7 the ADAA and the intent of FDMA will be reconciled
8 on this matter.
9 At that point I can conclude my
10 comments. Thank you.
11 (Applause.)
12 DR. WAGES: My name is Dennis
13 Wages, and I'm a veterinarian representing the
14 American Association of Avian Pathologists, which
15 is primarily composed of poultry veterinarians,
16 allied industries, commercial production, research
17 and academia. Veterinarians in AAAP are involved
18 in the production of over seven billion broilers,
19 300 million turkeys and 325 million table egg
20 layers, producing over eighty million eggs
21 annually.
22 One of the intents of the FDA
23 Modernization Act is to make available new animal
24 drugs for use in livestock. However circumstances
25 surrounding the recently discussed framework
30
1 document produced by FDA/CVM seems to have
2 disrupted the approval process and the potential
3 for new animal drug development. It's my
4 understanding that until the framework document is
5 finalized, new animal drug approvals are on hold.
6 Likewise, the major pharmaceutical players in our
7 industry have put the discovery of such new animal
8 drugs with potential use in poultry not only on the
9 back burner, but the discovery process for food
10 animal drugs as a whole has ceased.
11 Even though the intent of the
12 framework document was to increase the availability
13 of drugs used in veterinary medicine and provide a
14 comfort zone of use of antibacterials to all those
15 involved, in reality it has brought it to an end.
16 I would encourage CVM to encourage
17 the drug approval process while the framework
18 document is being fine-tuned, because there are
19 more questions than answers regarding the document.
20 Discovery of new and innovative therapeutic
21 regimens are vital to the food animal industry as
22 the arsenal of therapeutic agents declines.
23 From the FDAMA communications
24 listed on the CVM web page it's stated and we've
25 heard today that Dr. Henney places a high premium
31
1 and priority on making sure that science anchors
2 FDA's decision-making process. The poultry
3 industry is concerned where the science and the
4 risk assessments are associated with some of the
5 current thinking regarding antibacterial uses. Is
6 it not possible for an impartial or at least a
7 diverse panel to be identified by CVM to peer
8 and/or scientifically review studies and articles
9 that are released to not only CVM but professional
10 and private sectors to comment on the implications
11 of such articles.
12 For example, the study from
13 Minnesota regarding Campylobacter resistance in
14 ready-to-eat poultry raises some serious questions.
15 It's my understanding that the majority of the
16 Minneapolis-St. Paul chickens originates from one
17 company which, during the study, had not used any
18 flouroquinolones. Also during that same time
19 period, the National Chicken Council says that only
20 1.1 percent of the chickens in the United States
21 were even treated with flouroquinolones. It starts
22 in my mind a question, is there the potential for
23 this antibiotic to actually cause the resistance
24 that was noted? Although we don't have the true
25 answers, it raises concerns about potential
32
1 cross-contamination at the retail level, as
2 production companies have little control over their
3 product after it leaves the processing facility,
4 and other questions about ready-to-eat poultry.
5 The poultry industry has for many
6 years cautioned that much cross-contamination
7 occurs in repackaging of ready-to-cook chicken and
8 that proper preparation is necessary. Sometimes
9 these common-sense procedures are never emphasized
10 in the prevention of exposure to food-borne
11 pathogens at the CVM level. We believe that CVM
12 needs to take advantage at an educational level.
13 If we are going to place science in our decision
14 process, then let's do it based on scientific
15 experts from both sides of the question, both pro
16 and con, and not base our decisions on politics and
17 consumers -- excuse me, consumer groups, CDC or
18 actions from our European neighbors.
19 It seems initiatives and
20 directions are implemented when science does not
21 appear to support the decisions; not in all cases
22 but in some of the more controversial ones. A
23 diverse panel of scientific experts identified by
24 FDA/CVM could be valuable in determining the
25 scientific merit of reports that have a potential
33
1 for controversy. Get all the facts from all the
2 people and then make decisions. Likewise, the same
3 experts could be involved in aiding the Agency
4 into what scientific methods and applications are
5 needed that would hopefully result in data being
6 generated that all sides could derive value from.
7 There's no question that there are
8 two sides to every story. However, concerning the
9 antibiotic use controversy, there are pieces of the
10 scientific information that certain groups seem to
11 overlook, depending on their own agenda, and no one
12 more group is any more at fault than any other. I
13 would encourage CVM to continue to look at all
14 sides of the issues and determine the true risks
15 and outcomes of such issues.
16 For example, antibiotic use leads
17 to resistance. It's a known fact that the
18 antibiotic resistant bacteria concerning certain
19 microbials are found in certain animals and that
20 food-borne illness becomes more complex and many
21 factors need to fall into place. We need to
22 understand and to know that if, in fact, the
23 treatment of poultry and/or any other animals
24 actually does lead to antimicrobial resistance and
25 truly an untreatable or at least food-borne illness
34
1 that refractory to treatment in humans. If there
2 are food-borne illnesses that are, in fact,
3 refractory to treatment, is this caused by the use
4 of antimicrobials in poultry flocks? I guess
5 that's the $64,000 question that I think people,
6 especially science, needs to answer.
7 I would encourage the Agency to
8 focus on the probability of the occurrence of such
9 antibiotic use when it's controversial and the
10 probability of such use and not the possibility of
11 such use.
12 Risk assessment is the buzz word
13 in the world of regulatory affairs and we feel that
14 it's the appropriate scientific route of choice for
15 some of these issues that face us. Retrospective
16 studies with adequate numbers of groups represented
17 to epidemiologically demonstrate that there is,
18 indeed, a cause-and-effect relationship of the use
19 of these antibacterials in veterinary medicine with
20 the result being a food-borne illness refractory to
21 treatment.
22 There are many statistic-
23 gathering mechanisms in process concerning
24 antimicrobial resistance that needs to be
25 correlated, evaluated and disseminated to
35
1 stakeholders. NARMS, Food-Net, Food Safety
2 Initiative, post-approval monitoring programs are
3 all in various stages of data collection. This
4 information needs to be carefully evaluated and
5 disseminated and to avoid misinterpretation of the
6 data.
7 What information is public versus
8 what is proprietary and where is this information
9 to be consistently found? This is information
10 that's being generated that can put all the pieces
11 of the puzzle together, but also pieces of that
12 information can be used to carry on certain
13 agendas.
14 We don't have all the answers, but
15 hope that the future direction of FDA/CVM be driven
16 by the emphasis placed on addressing these issues
17 scientifically and not do what may be politically
18 correct.
19 I don't envy the pressure that CVM
20 has put on them from all sides. Strengthening the
21 agency science base through well-defined studies
22 that are going to tell us what we need to
23 know is paramount. I think we need to outline
24 objectives, design a plan of action that answers
25 the key questions to our objectives.
36
1 Let us ask ourselves: What
2 information do we have that's available to us right
3 now that provides us insight and what gaps are
4 there present in the information, and then what do
5 we need to do to formalize an evaluation process
6 that will be meaningful and address the Agency's
7 objectives and concerns?
8 Outside objective evaluation of
9 the plan of action and studies to be implemented
10 are key to the success of the Agency's goal to
11 strengthen its science base. As you are doing
12 today, allowing all stakeholders to be involved as
13 to the future of assessing public health risks is a
14 vital part of it.
15 The future of antimicrobial use in
16 all medical professions and the future availability
17 of drugs depends on the Agency's process as to its
18 future direction. Of course actions will always
19 speak louder than words.
20 Thank you for allowing me to
21 address these concerns of the poultry industry and
22 the poultry veterinary concerns to you today. I
23 feel that FDA/CVM will direct themselves in a
24 manner that will provide the comfort zone for all
25 stakeholders involved in these hot and very
37
1 controversial issues. Thank you.
2 (Applause )
3 MR. WADDELL: I'm John Waddell.
4 I'm a practitioner from Nebraska. I'm here
5 representing the American Association of Swine
6 Practitioners.
7 The AASP is a professional
8 organization of over 1300 veterinarians in the
9 United States. Our members are integrally involved
10 in all aspects of swine health and production. The
11 AASP has a vested interest in assisting the FDA,
12 and specifically the CVM, in implementation of the
13 FDA Modernization Act.
14 Modernization is a continual
15 process for any organization. Without some plan to
16 improve, any organization, including the FDA, may
17 find itself providing no real value to its
18 customers or stakeholders. The development of
19 creative strategies as part of this improvement
20 process but true and measurable success depends on
21 the implementation of these strategies; therefore,
22 the implementation of ideas and strategies
23 discussed today will speak much louder than any
24 words that will be spoken here.
25 One of the stated objectives under
38
1 FDA's Modernization Act is to strengthen its
2 science base. We applaud the CVM in its desire to
3 use science in its decision-making.
4 The application of science can be
5 a powerful tool. This raises the key issue of what
6 level and kind of science is needed. The intuitive
7 answer is that we need good science; however CVM
8 needs to identify the attributes of good science,
9 which include methodology and verification. Good
10 science is not intuition and perception.
11 It is often tempting to forego
12 science in the face of expediency and emotionalism.
13 When science is not available, the challenge is not
14 merely strengthening the science but also involves
15 the balance between politics and science.
16 Regulatory decision-making needs to balance
17 political agendas and science. The line between
18 the two often becomes obscured and distorted.
19 Unfortunately, in the absence of science, political
20 expediency rules the day. We must not let that
21 happen.
22 We urge the FDA/CVM to remain
23 committed to using science in the risk-based
24 decision-making process. Before the FDA finalizes
25 any decision, perhaps the following question should
39
1 be asked: Will the decision significantly lower
2 the risk to public health?
3 Most AASP members practice in a
4 world of applied science. Science dictates what
5 medication and what treatment regimen to use. It
6 dictates the avoidance of violative residues. It
7 is this adherence to science that ensures we are
8 producing a healthy and safe food product while
9 securing the livelihood of our clients.
10 Can you imagine what would happen
11 if veterinarians disregarded our scientific
12 knowledge? What will FDA's decisions be like if
13 they disregard scientific knowledge?
14 For veterinarians our measure of
15 success in the field are well-defined.
16 Unfortunately, the measure of success for
17 regulatory decision-making is not always so
18 clear-cut. However, this does not diminish the
19 need to discover and identify the attributes of
20 strong science as the CVM incorporates the
21 state-of-the-art science in its decision-making
22 process.
23 How can CVM strengthen its
24 science? The first step is to define a process
25 that can objectively review and select appropriate
40
1 studies and investigations that are pertinent to
2 the decision at hand. The agency should not
3 utilize a subjective process of intuition and
4 perception that biases the decision-making
5 process. Any selective use of data to accomplish a
6 political agenda does little to protect the public
7 health, nor does it build the credibility of the
8 Agency.
9 Strong science must be considered
10 when drawing data from many disciplines and
11 sources. The application of experimental research
12 can be extremely limited and biased. For example,
13 so-called bench research can prove that some event
14 is possible. The question then becomes: Is this
15 significant in terms of applied science? In light
16 of such research, I return to the original question
17 posed to decision-makers earlier: Will this
18 decision significantly lower the risk to public
19 health?
20 Strong science dictates that each
21 scientific discipline be placed in perspective with
22 relation to its value to the decision process. For
23 example, we are faced with the issue of
24 antimicrobial resistance. This issue is
25 overshadowing everything else that CVM is currently
41
1 doing. Epidemiology is a discipline that seems to
2 be occupying much of the discussion on the issue.
3 As an investigational science, epidemiology relies
4 on observing populations and then making inferences
5 about those observations. The subjective nature of
6 inferences can allow errors that bias the
7 interpretation of data, thus weakening the science.
8 Biological systems are inherently
9 variable. Attempts to misrepresent a state of
10 nature may provide sensational news stories and
11 good editorial fodder, but they do little to
12 strengthen the science. Superbugs may be today's
13 headlines, but such sensationalism has no place in
14 an attempt to strengthen the science in
15 decision-making.
16 Strong science embraces the
17 concept of consistency in a number of different
18 circumstances. Any attempt to oversimplify a
19 cause-and-effect mechanism and the interventions
20 required to mitigate a risk may produce unintended
21 consequences. The failure to account for
22 variability in veterinary medicine and the
23 production of food animals will do little to
24 protect the public health, but it may unwittingly
25 devastate an agricultural industry.
42
1 CVM must recognize the limitations
2 of the science that is available for their
3 decision-making. The agency must be prepared to
4 deal with variability and uncertainty. It must not
5 use the lack of data as an excuse to employ
6 unscientific reasoning such as the precautionary
7 principle. The precautionary principle is based
8 primarily on perception and intuition, not
9 characteristics of strong science.
10 The logical place to start in the
11 agency's quest for effective risk-based
12 decision-making would seem to be the use of
13 scientific risk assessment. The attainment of some
14 understanding of the presenting level of risk,
15 whether qualitative or quantitative, is essential.
16 Without this in place, the Agency cannot begin to
17 come to grips with the level of science or data
18 needed for the process.
19 A great deal of the value of
20 determining acceptable risk and understanding a
21 level of risk is the role that they can play in
22 assuring the CVM's limited resources will be
23 allocated to achieve the greatest impact.
24 The concept of risk assessment is
25 also consistent with the efforts of other
43
1 governmental agencies. By clearly understanding
2 the areas of greatest risk and employing a more
3 comprehensive and systematic approach, the CVM can
4 utilize a cooperative approach to improving food
5 safety. The U.S. Department of Agriculture,
6 through the Food Safety and Inspection Service,
7 represents an important resource to mitigate the
8 risk of food-borne disease at the point of
9 slaughter.
10 CVM's demonstration of its
11 willingness to adopt a formal risk assessment
12 approach and strengthen the science will enhance
13 the Agency's credibility and its efforts to
14 communicate with its stakeholders.
15 A key factor in improving
16 communication is trust. Unfortunately, there
17 appears to be very little trust present between the
18 CVM and its stakeholders. This lack of trust
19 should not be misconstrued as malicious intent by
20 any party. It is, however, symptomatic of the
21 uncertainty and lack of transparency in the
22 decision-making process.
23 Consistent and sustained
24 communication efforts are required by all
25 involved. Stakeholders cannot be embraced by CVM
44
1 during its modernization efforts and then held at
2 arm's length with disdain during the decision-
3 making process. Likewise, CVM cannot be portrayed
4 as the enemy with no redeeming value for animal
5 agriculture or public health.
6 When faced with uncertainty from a
7 lack of science, CVM should look to its
8 stakeholders for assistance. The timing of such a
9 request is vital. If the decision-making process
10 has proceeded too far, the assistance will have
11 little value or real impact on the process. When
12 the process has gone too far, stakeholders have to
13 wonder whether their input was desired at all or
14 whether it was merely window-dressing needed to
15 satisfy a statutory requirement. The result is
16 the loss of credibility in these situations. FDA
17 needs to bring the stakeholders into the process at
18 the earliest moment.
19 Stakeholders have an obligation to
20 respond with credible data where available. When
21 data is not available, stakeholders should provide
22 expert assistance in setting the research agenda
23 and perhaps in conducting pertinent research. A
24 fostering of communications, collaboration and
25 cooperation must take place if CVM wishes to be
45
1 efficient and effective at meeting its
2 responsibilities.
3 I thank you for this continuing
4 opportunity to offer comment. As I stated before,
5 the development of creative strategies is part of
6 modernization, but true and measurable success
7 depends on the implementation of these strategies.
8 Any resulting action from today's discussion will
9 speak much louder than any words spoken here.
10 (Applause.)
11 MR. ROGERS: Pork Producers will
12 have five minutes each.
13 MR. SUNDBERG: Good afternoon.
14 I'm Paul Sundberg. I'm the Assistant Vice
15 President of Veterinary Issues from the National
16 Pork Producer Council.
17 I want to begin by thanking the
18 agency for the opportunity to offer comments this
19 afternoon on behalf of approximately 85,000
20 producer members in 44 affiliated state
21 associations.
22 The National Pork Producers
23 Council is committed to the evaluation of
24 scientific data to assess many of the issues that
25 affect our industry. We have a series of pork
46
1 producer committees that do this with the advice
2 of a variety of scientific experts. They then take
3 their evaluation and look at various management
4 alternatives and develop communication strategies
5 when appropriate.
6 I'd like to offer some comments on
7 the Agency's strategic directions as well as the
8 specific questions posed in the Federal Register
9 notice of this meeting.
10 The first two strategic directions
11 and the first question in the Federal Register
12 bring together the concept of scientific analysis
13 and risk-based decision-making. Our comments at
14 the last VMAC meeting demonstrate our support of
15 the use of science to assess risk. It's clear the
16 continuing challenge is to evaluate the accuracy
17 and appropriateness of the science.
18 There seems to be at least two
19 primary research areas that have occupied much of
20 the debate about the risk of antimicrobial use in
21 agriculture and how it affects public health.
22 Therefore, two examples are bacteriology and
23 epidemiology, and these two are really two
24 different examples of approaches to a science-based
25 mechanism.
47
1 The first, bacteriology, has
2 focused on the laboratory discovery of the genetic
3 basis for resistance, its mechanism of action and
4 its transmission from one individual bacterium to
5 another. We have improved our scientific
6 techniques from describing R factors to an
7 investigation of integrons and transposons. In the
8 years to come we will find even more innovative
9 ways that bacteria adapt to their environment.
10 This doesn't imply these are new bacterial
11 mechanisms, only that our discovery or
12 understanding of them is new.
13 Laboratory experiments are limited
14 by the laboratory conditions under which they're
15 conducted. There's a danger of taking the results
16 or the findings of the experiment as a template of
17 what happens outside of the lab. The field does
18 not have the ability to control laboratory
19 environment.
20 Epidemiology has been defined as
21 the study of patterns of disease that exist under
22 those field conditions; the frequency, distribution
23 and determinants of health and disease of
24 populations. The unit of interest is the
25 population and not the individual. It's useful to
48
1 provide some data that suggests associations among
2 health determinants but usually not a
3 cause-and-effect relationship.
4 As with other sciences, all of
5 these data are only valid if it has the power to be
6 supported by statistical analysis, if the study was
7 designed properly and if it makes intuitive sense.
8 Epidemiological studies that fail in any of these,
9 as with the other bench sciences, may divert our
10 attention, efforts and resources.
11 As Dr. Waddell said, unfortunately
12 peer review publication does not always insure
13 equality. For the Agency to stand on a risk-based
14 decision-making policy it has to use the best
15 information available from the bench sciences and
16 the field sciences to do a risk measurement or
17 assessment. Using just one discipline will
18 dangerously narrow and invalidate any assessment of
19 risk and probably will be misleading. This is true
20 whether you're using only bacteriology,
21 epidemiology or any other scientific discipline. A
22 systems approach is needed for risk assessment to
23 be scientifically valid -- similar to that of the
24 Agency's strategic directions that calls for a
25 systems approach to Agency regulation and looking
49
1 for problem solutions rather than piecemeal review
2 and enforcement. Only then can it reasonably
3 assume what policies are going to have an effect on
4 the risk.
5 The first question asks what
6 actions the agency can take to expand its
7 incorporation of state-of-the-art science into its
8 risk-based decision-making. The Agency should
9 develop the model so that it can assure itself that
10 its decision-making is, in fact, risk-based, using
11 the expertise available within and without the
12 agency to define and develop risk-based risk
13 assessment approach. This will ensure the
14 inclusion of the state-of-the-art science because
15 the risk assessment model has be to continually
16 refined as more information comes available. Once
17 the model for risk assessment is developed through
18 a transparent, scientifically defensible process,
19 the agency, in conjunction with its stakeholders,
20 can move on to the risk management and risk
21 communication portion of the total risk analysis.
22 The basic message is to follow the
23 risk analysis process and not implement risk
24 management policies before doing an assessment of
25 the risk. The risk communication strategy appears
50
1 to be the point of Question 3, the actions needed
2 for educating the public. This is exactly why the
3 agency must have already completed the defensible,
4 credible assessment of risk, to communicate those
5 strategies to the public. Without that credible
6 assessment, its message of the balance between
7 risks and benefits may not be believable or even
8 well founded. Completing an assessment of risk and
9 the transparent transfer of risk management policy
10 will give the stakeholders the tools that will
11 enable them to carry the FDA's message to the
12 public.
13 We stand ready to help the agency
14 in this task. The nation's pork producers are
15 willing to spend their own checkoff money on this
16 because they recognize the important role of
17 science in this issue.
18 I'd like to introduce Barb
19 Determan. She's a pork producer from Iowa, also
20 from the National Pork Producers Council.
21 And I'd also like to thank the CVM
22 to allow us to split up our time.
23 MS. DETERMAN: As Paul said, I'm a
24 producer from Early, Iowa. Myself and my husband,
25 Steve, and our three children have a family farming
51
1 operation in northwest Iowa. Our farrow-to-finish
2 operation produces about 2000 head of hogs a year.
3 I am a volunteer for the National Pork Producer
4 Council. I donate my time to represent producers
5 from across the nation.
6 I appreciate the opportunity to
7 talk with you this afternoon about the agency's
8 reliance on science to meet its obligations. I
9 would like to give you my perception after I've had
10 a chance to meet with the CVM on two occasions on
11 its decision-making process. Thank you for those
12 two opportunities as well as this one today.
13 Meetings like this are very
14 important in helping to foster open communication
15 and exchange of ideas between the CVM and its
16 constituents. We also need to explore new ways
17 that this can go farther. The CVM has people with
18 the decision-making power. Those decisions will
19 affect the way that the nation's pork producers, my
20 husband and myself live and work every day. I
21 think all of us -- CVM and the pork producers --
22 have a common goal of food safety and the
23 preservation of public health. There needs to be
24 an effective mechanism, how we work together to
25 help reach that goal. We need to better understand
52
1 the constraints that the agency works under, and
2 you need to better understand our business and how
3 we work. One of the most important outcomes of
4 these types of meetings is to talk about how that
5 mechanism can be developed.
6 I would also like to say a few
7 things about what I saw at the last Veterinary
8 Medicine Advisory Committee meeting. CVM had
9 gathered an impressive group of experts and
10 advisors. However there was only one practitioner
11 on the committee that had any idea of how
12 veterinary medicine works in everyday practice, and
13 that person chaired the meeting, which limited his
14 ability to offer input. If the VMAC is to be
15 effective, let it contribute the real life
16 understanding of veterinary medicine that CVM
17 needs. Speaker after speaker tried to offer that
18 input during the first day, but when it came to the
19 discussions of the Committee during the second day,
20 there was no indication that what we had tried to
21 convey had any effect on the outcome.
22 I recently had the opportunity to
23 travel to Europe to talk with Swedish producers,
24 scientists, officials and veterinarians about how
25 they raise pigs and use antibiotics.
53
1 One of the things I learned was
2 that they're relying more on politics than they are
3 on science. In fact, science is basically on the
4 run in Europe. Many of their policies are based on
5 marketing decisions and posturing of one country
6 against the others. This is not a good example for
7 the CVM and their science-based decision-making.
8 In a recent issue of Meat
9 International, a trade magazine for international
10 meat associations, there was an interview with Anne
11 Birgitte Lundholt, the managing director of Danske
12 Slagterier, the federation of producers and
13 slaughterhouses in Denmark. When she was asked
14 about the EU ban of certain antibiotics as growth
15 promoters and what the effect has been on
16 production, she said, "Scientifically growth
17 promoters do not seem to be a problem, but we find
18 it impossible to explain to the average consumer
19 that medicine has to be given to healthy pigs. It
20 [banning growth promoters] is against our normal
21 philosophy of following science."
22 When we talked with Danske
23 Slagterier during our trip, we were told of the
24 Danish plan to stop using all growth promotant
25 antimicrobials, even nursery-age pigs. The
54
1 scientists told us that it was strictly a political
2 decision that was the result of a slow news time
3 during last summer.
4 The last thing we need to learn in
5 this discussion is that as we talk about the basis
6 of science for decisions is that we all need to
7 maintain our advocacy for the role of sound
8 science. The Centers for Disease Control has
9 become an advocate for the European philosophy.
10 During the VMAC meeting we were told that we had
11 better move along with this issue because we didn't
12 know what it was like to stand by the bed of a
13 dying child. The CDC's Dr. Angulo was quoted in
14 the Food Chem News as saying that he, -- and then
15 presumably the CDC, was fully supportive of the
16 recent CSPI petition to ask for the banning of all
17 subtherapeutic uses of antimicrobials.
18 I'll let the scientists argue
19 that, because, as you can tell, my name doesn't
20 have all the letters behind it; I just raise pigs.
21 What I have to offer is my opinion that the CVM
22 needs to be an advocate for its positions. If it
23 wants to stand on scientific judgment, then it
24 should be ready to express that policy and refute
25 the ones that don't. Numerous scientific bodies
55
1 have said that the risk of agricultural uses of
2 antimicrobials has not been determined, but there
3 is no imminent hazard. We need to stand by our
4 positions on sound science and become its advocate
5 or we will find ourselves that we could be in a
6 period of slow news and be forced to abandon it
7 strictly because of policies.
8 The National Pork Producers
9 Council is spending our pork producer checkoff
10 dollars to try to supply some of the scientific
11 answers we need, and we offer all the help we can
12 help you in continuing those efforts.
13 Thank you.
14 (Applause.)
15 MR. ROGERS: Before we dismiss
16 this panel, I'd like to ask the FDA group if you
17 have any clarifying questions of any of the
18 panelists.
19 (No response.)
20 MR. ROGERS: Hearing none, thank
21 you so much for your input.
22 (A short recess was taken.)
23 MR. BREEN: We'll get started for
24 the last session.
25 First of all, my name is Charles
56
1 Breen, and I'll be filling in for Mike Rogers this
2 afternoon. As you'll notice, there's a difference
3 between the previous man standing over here in the
4 dark suit and myself.
5 To continue, Dr. James A. Jarrett,
6 Executive Vice President of the American
7 Association of Bovine Practitioners.
8 DR. JARRETT: Thank you, David.
9 I'm Jim Jarrett. I'm the Executive Vice President
10 of the American Association of Bovine
11 Practitioners.
12 AAVP is an organization of over
13 5500 veterinarians, each with at least some
14 interest and involvement in cattle medicine. We
15 have members who are highly specialized in their
16 practice and members who see only one or two cows a
17 week; so we are quite varied in our interest.
18 We all share the knowledge that
19 all of our bovine patients are only one conception
20 away from McDonalds. They are all part of the
21 human food chain, all of them. We all share a
22 sense of responsibility for the health of the
23 nation's cattle herd and the wholesomeness of the
24 human food that it produces. We believe this food
25 to be as safe as is humanly possible to make it.
57
1 This is supported by the fact that the incidence of
2 food-borne illness as a result of anything that
3 happens at the farm level is at an all-time low.
4 We support our other animal
5 agriculture interests that have gone before me
6 today. And at the risk of saying "Me, too," and
7 sitting down, I will continue. But we will be
8 supportive -- where is Paul? -- all of you guys,
9 and appreciate what you had to say as well.
10 Our mission is to prevent pain and
11 suffering in our patients and to ensure that the
12 pathogen level in food for animals is as low as is
13 humanly possible to make it.
14 To do this, from time to time we
15 need various therapeutic agents. This brings us in
16 closer contact with the FDA/CVM than any other
17 public agency, including the IRS. We appreciate
18 the opportunity for input.
19 DR. TOLLEFSON: We've never been
20 compared to the IRS.
21 DR. JARRETT: We appreciate the
22 opportunity for to give input. We are encouraged
23 by the report of the following of the stakeholders
24 meeting in August of 1998.
25 Today I've been encouraged by
58
1 statements such as risk-benefit ratio. I've been
2 encouraged by statements that refer to a global
3 economy, and would stress the need to keep American
4 agricultural on a level playing field with our
5 producing comrades around the world.
6 I am encouraged by a proposed
7 increase in the dollars for outreach and
8 enforcement as depicted by Dr. Sundlof slide
9 earlier today.
10 Some of our members have the
11 perception that FDA serves only the consumer
12 interest and perceived needs using questionable to
13 marginal science. As an example, the current
14 intense activity over antimicrobial resistance is
15 being an issue that, at the moment, has limited
16 human health impact. Much of the action assumes
17 that there is a problem or a hazard to human health
18 that has yet to be demonstrated.
19 We have concerns that many actions
20 and decisions seem to be based on marginal science
21 at best and false information to emotionalism at
22 worst. However, based on the premises that there
23 might be a problem, animal agriculture is being
24 proactive with its efforts to formulate such things
25 as prudent or judicious use guidelines and
59
1 distributing them to our end user members. We are
2 making available to the practitioner database and
3 data information on the selection dosage and usage
4 of antimicrobial agents, including the choice of
5 drugs as well as the dosage, terms of therapy and
6 such information. This information is and will be
7 made available to the practitioner to use as he or
8 she makes decisions about controlling pain and
9 suffering in our food animal patients at the same
10 time.
11 However, we vigorously oppose any
12 formulary or any edict that might tell or take away
13 any of the responsibility or the decision-making
14 power of the practitioner in the field.
15 This brings me to respond to the
16 five questions. Some of this response will be a
17 repeat from the last meeting in August, and I
18 apologize for this.
19 The first question, though, I am
20 impressed, though, that all these questions begin
21 with the phrase, "What actions do you propose?"
22 There have been many actions proposed by previous
23 speakers, and I'm sure by those who will follow as
24 well as some of the comments that I will have.
25 I'm most concerned about how we
60
1 incorporate true science in a risk-based
2 decision-making process, as related to the first
3 question.
4 Monitoring is certainly a part of
5 any concern or any evaluation of antibiotics or
6 therapeutic agents. We certainly support some kind
7 of monitoring program; however, we have concerns
8 about how samples might be selected and collected
9 and how the results might be used. We would
10 encourage -- and I would encourage this as a part
11 of all five responses -- the inclusion of
12 veterinarians and other livestock producers with
13 experience at the production level in the
14 decision-making process, along with non-agency
15 experts that have already been alluded to.
16 The second question refers to the
17 actions needed or suggested to help in the exchange
18 and integration of scientific information. We
19 would suggest, as I have before, the utilization of
20 the existing channels of communication, such as the
21 American Association of Bovine Practitioners, the
22 American Association of Swine Practitioners, the
23 American Veterinary Medical Association, and yes,
24 Dennis's poultry veterinarians, along with many
25 other existing groups that are there with excellent
61
1 communicating channels already in place. Again,
2 the inclusion in this one as well of non-agency
3 experts and outside assistance in formulating
4 education programs.
5 Number 3 deals with educating the
6 public about risk versus benefits. I take this to
7 mean that there will be such a program and praise
8 the Agency for this. This should include such
9 information as resistance versus a shift in
10 susceptibility. We feel it should identify some of
11 the weakest public health links and concentrate
12 efforts on these. Antimicrobial resistance may or
13 may not be the weakest current public health link
14 as it applies to food animal agriculture. And
15 again, including outside experts and outside
16 assistance as actions are formulated.
17 Question 4 focuses on action to --
18 focus resources on areas of greatest risk. Here I
19 would like to repeat some of the statements that I
20 made at the August meeting. Many and most of our
21 members would like to see the agency enforce
22 current regulations before enacting new ones and
23 feel that the enforcement of current regulations
24 would go a long way toward helping to alleviate
25 some of the problems currently seen.
62
1 I'm encouraged by the increased
2 funding that is being asked for in the area of this
3 effort and the recent requests of CVM-FDA for
4 funding to be applied in the area of surveillance
5 and enforcement.
6 Most of the problems that we deal
7 with today are caused by a few producers and
8 veterinarians. Any action in the area of bringing
9 this under control, we feel, must help in terms of
10 solving the overall problem.
11 As an example of some of these
12 problems, I could state just recently a request for
13 all the members of the AABP in several states to be
14 supplied to a compounding pharmacist. I did not do
15 this and don't plan to. I would, in addition,
16 quote -- or, rather, relate the fact that at a
17 recent -- within the last three or four months at a
18 major veterinary meeting in the exhibit hall, three
19 booths promoting compounding pharmacists. This
20 kind of activity can do nothing but, in our
21 feeling, deter and deliver the wrong message to our
22 clients and to many veterinarians in the field.
23 Question No. 5 refers to
24 additional action items to enhance communication.
25 Again, I would repeat, the involvement of existing
63
1 channels of communication such as the organizations
2 that are here today; and I would, again, as I did
3 at the August meeting, encourage the exchange on a
4 one-on-one basis between members of the agency and
5 personnel in the field.
6 In summary, I would like to
7 enforce or encourage the enforcement of existing
8 regulations before new ones are formulated. I
9 would like to encourage the allowing of time for
10 current industry changes to take effect,
11 particularly in microbial resistance in such areas
12 as prudent use, and I would commend the agency for
13 listening to its stakeholders in meetings such as
14 this today and look forward to the resulting
15 actions and changes as a result.
16 Thank you.
17 (Applause.)
18 MR. BREEN: Richard Wood,
19 Executive Director of Food Animal Concerns Trust.
20 MR. WOOD: Thank you for the
21 opportunity to respond to the questions related to
22 the FDA Modernization Act.
23 I am Richard Wood. I am the
24 Executive Director of FACT, or Food Animal Concerns
25 Trust.
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1 FACT is a consumer organization
2 with about 30,000 constituents nationwide. We
3 advocate farm management systems that promote the
4 safety of meat, poultry and eggs. We have a food
5 safety policy program that is based on our review
6 of scientific literature, and our farm projects.
7 We now have one project working with thirteen farms
8 in Pennsylvania as well as in Hawaii where we have
9 a Salmonella control program for an egg-layer
10 system, and we're now working on a niche marketing
11 project with hog farmers in the Midwest.
12 Coming to the FDA questions. As a
13 consumer-based organization, we must rely on the
14 scientific research of others. We are not
15 scientists, but that does not exclude us from this
16 table. For all of our experience, we do bring to
17 the table critical real-life questions about the
18 safety of the food we eat. As we turn to the
19 federal regulatory agencies, our questions become
20 expectations as to how these agencies will address
21 our food safety concerns. Granted, we could each
22 develop a clinical list of expectations, but in our
23 best moments as consumers we have some expectations
24 that are not content filled as far as precise
25 content, but they are filled in terms of outcome.
65
1 There are expectations in terms of outcome.
2 Our expectations are that the
3 regulatory agencies will gather all the data
4 necessary to make a well-founded decision; that
5 they will conduct unbiased research to the greatest
6 extent possible; thirdly, that they'll provide a
7 decision-making process that is transparent, giving
8 opportunity for input and feedback from all the
9 affected parties along the way; fourth, that the
10 regulatory agencies will have the power to
11 implement and enforce the resolutions fairly across
12 the board wherever the threat or the need exists;
13 and, fifth, that there will not be delay in the
14 face of a food safety threat immediately related to
15 public health.
16 It is in this context that I'd
17 like to address the questions put before us by the
18 FDA.
19 FDA Question 1: What actions do
20 you propose the Agency take to expand its
21 state-of-the-art Science? The FDA Center for
22 Veterinary Medicine is about to implement a
23 framework document that many have talked about
24 today. I probably should have put this speech away
25 and pulled out my framework speech, because that
66
1 does seem to be the topic at hand. I do have some
2 comments about it. But in the context of relating
3 to the FDA questions, we do strongly support the
4 framework document and want to see it implemented.
5 I probably should sit down. But that's the
6 position.
7 We also have a whole list of
8 questions that we have raised, both publicly and
9 through our comments about the framework document,
10 as other groups have questions. Some have
11 questions as to whether or not the framework is
12 based on good science. We see the framework as a
13 helpful expression both of what works and what
14 needs to be replicated in the Agency, and also an
15 expression of what doesn't work within the Agency
16 as it addresses food safety issues.
17 What works? Well, the framework
18 proposes to gather a wide range of data regarding
19 the sale of antibiotics and their use on farms.
20 The pharmaceutical companies are being asked to
21 provide sales information. CVM is also proposing
22 to initiate on-farm monitoring for antibiotic
23 resistance, in addition to the information secured
24 through the National Antimicrobial Monitoring
25 Systems, or NARMS. Gathering actual use data
67
1 should make it possible to link antibiotic use with
2 decreased susceptibility when an event occurs to a
3 particular drug, and thereby to make possible
4 realistic mitigation strategies.
5 In our view this proposal is a
6 model for how the FDA should go about making its
7 decisions, and it's part of the answer to their
8 first question regarding expanding its scientific
9 capabilities. Gather all the data necessary to
10 make a well-founded decision.
11 However, the framework fails as a
12 model when it comes to the FDA implementing their
13 proposals across the board wherever the need may
14 exist. This is where you say they've gone to far,
15 and we say they haven't gone far enough. The
16 framework proposal is essentially prospective,
17 addressing only new animal drug applications.
18 Our expectation is that this
19 response to potential antibiotic resistance should
20 be applied to all animal antibiotic approvals, past
21 and future. With approximately fifty million
22 pounds of antibiotics already going to the farm
23 each year, all approvals should be included within
24 one post-approval resistance monitoring scheme, and
25 that would then create a level playing field for
68
1 all antibiotics used with food animals.
2 Question 2. What actions do you
3 propose to facilitate the exchange and integration
4 of scientific information? In our view, consumers
5 expect that a food safety regulatory agency will
6 conduct unbiased and thorough research.
7 We all know that lack of funding
8 is major a limiting factor of the FDA. It's
9 heartening to see the bar graph where there is
10 increased research funding thanks to some of the
11 initiatives that are going on. But there are some
12 endemic problems, in our view, that would not be
13 fixed by more money. This has to do with the
14 duplication of roles within the Agency and among
15 the regulatory agencies. We were glad to hear the
16 commissioner address that concern earlier today.
17 In response to Question 2, for
18 there to be an exchange and integration of the
19 scientific information, clear roles and authority
20 must exist. FDA through FDAMA is presented with an
21 excellent opportunity to take further steps to
22 clarify how research is conducted within the agency
23 and how it coordinates its efforts with other
24 governmental agencies, like the ARS and FSIS and
25 others.
69
1 We call for continuing
2 preservation of the Joint Commission and the Joint
3 Council on Food Safety.
4 Second of all, we encourage the
5 exchange of scientific information between the FDA
6 and academia and industry researchers. FACT calls
7 on the FDA to maintain and expand its own expertise
8 and research base, that part of the pyramid that
9 was laid out by Dr. Sundlof.
10 I recently had the opportunity to
11 visit the CVM lab in Maryland, where the agency is
12 addressing a number of animal health issues. What
13 impressed me most during my visit, as a lay person,
14 were areas in which CVM research was addressing
15 critical animal health questions where neither
16 academia nor industry research was to be found.
17 Isn't that the way it's supposed to be? The focus
18 on the exchange and integration of scientific
19 exchange of information, we call on the FDA to
20 maintain its own unique contribution to the process
21 of scientific research.
22 Moving on to Question 4: What
23 actions do you propose to enable FDA to focus
24 resources on areas of greatest risk? First we feel
25 that FDA must maintain its focus on priorities
70
1 established through the Food Safety Program and
2 also projects established by its own actions. As a
3 consumer group we hold the FDA accountable for what
4 it says it's going to do. The FDA is part of the
5 President's Food Safety Initiative. FACT expects
6 the Center for Veterinary Medicine to fulfill the
7 food safety priorities as assigned. Sometimes we
8 look at the bar graphs and say that's stuff we have
9 to do. Well, it's there because we wanted it to
10 happen, along with others, apparently, across the
11 nation.
12 The CVM must also fulfill commitments
13 that it has made in other areas, such as enforcing
14 the mammalian to ruminant feeding ban and
15 implementing regulations related to antibiotic
16 resistance. As priorities, these are areas that
17 should be held harmless from shortfalls in FDA
18 funding.
19 Second, in terms of Question 4,
20 risk assessment should be conducted within a time
21 frame that allows for regulatory response as soon
22 as possible. In our view, as we've experienced
23 risk assessments among regulatory agencies, risk
24 assessments have too often become the science of
25 the delay. CVA is less guilty of this, quite
71
1 frankly, than other FDA centers or agencies, but to
2 use an example from another area, in December of
3 1996, the FSIS began a risk assessment of
4 Salmonella enteritidis in shell eggs. We supported
5 that assessment. We provided that assessment
6 volumes of material. And maybe we provided them
7 too much material, because two years passed and no
8 risk assessment was published. In May 1998, an
9 ANPR was published as a joint FSIS-CFSAN effort,
10 but still no risk assessment was published.
11 Findings from the risk assessment was published
12 after the deadline for comments on the ANPR and
13 findings from the risk assessments then had to be
14 incorporated back to the ANPR. To date there's
15 been no further public movement toward a rule on SE
16 and shell eggs.
17 We applaud CVM for moving in a
18 timely fashion on both the BSE rule and
19 implementing the framework document.
20 Third, FACT is concerned about CVM
21 reliance on third parties to perform its reviews.
22 At several points in the Compliance Plan, the FDA
23 refers to the need to rely on third parties to
24 essentially speed up the drug approval process, a
25 necessary goal. While FDAMA allows CVM to work
72
1 with third parties, we do not support an
2 arrangement where the sponsor selects and pays for
3 the contractor. FDA, we feel, needs to control the
4 review process, even if third party contracts are
5 established.
6 Finally, in response to the
7 funding question. It may seem that we've not
8 helped very much. We want a food safety
9 initiative. What's that? 3.5 million at least?
10 We want enforcement of the BSE regulations. Ching.
11 We want post-approval surveillance of all
12 antibiotics. Ching.
13 Quite frankly, as consumers we can
14 only point to the need from our perspective. There
15 are numerous areas of CVM cost that we have not
16 identified, particularly with the implementation of
17 ADAA. But we bring to you our priorities and
18 concerns. Even though we are not in a position to
19 say what to cut, we are in a position to work for
20 adequate funding for this Center as it addresses
21 food safety.
22 Finally, the last question. FACT
23 supports FDA's objective of obtaining input from
24 external stakeholders and encourages the continued
25 use of its advisory committees for that purpose, as
73
1 well as meetings such as today. We expect that the
2 decision-making process at the FDA will be
3 transparent, with feedback coming from all
4 stakeholders, including consumer groups. For
5 consumer groups, the FDA Office of Consumer Affairs
6 is invaluable and the web site is helpful as well,
7 even though many of the decisions facing CVM and
8 FDA require scientific expertise, we call on the
9 FDA to continue to involve lay people in the
10 process. Science without a connection to people's
11 experience is an abstraction and will lead the
12 agency in meaningless directions.
13 Thank you.
14 (Applause.)
15 MR. BREEN: Our next speaker is
16 Joel Brandenberger, Vice President of Legislative
17 Affairs for the National Turkey Federation.
18 MR. BRANDENBERGER: Thank you.
19 My name is Joel Brandenberger,
20 Vice President of Legislative Affairs for the
21 National Turkey Federation. I represent,
22 obviously, the processors and producers of turkey
23 nationally. We really do appreciate the
24 opportunity to be here today. In fact, we've done
25 this with folks from CVM in a number of different
74
1 venues over time. Maybe for fun we ought to do
2 each other's presentation and see how it turns out.
3 I'm going to focus primarily on
4 some of the questions regarding implementation of
5 the Animal Drug Availability Act. But before I get
6 to that, I would like to take just a moment to
7 endorse some things that Rich Carnevale said, from
8 AHI, Barb and Paul and Dr. Waddell -- I guess he's
9 gone now -- and endorse their comments,
10 specifically as they concern risk assessment and
11 the antibiotic framework. Some of the gains which
12 we're about to talk about that have been made by
13 the ADAA could be put at risk if we make regulatory
14 changes to the approval process for antibiotics
15 that are not based on real risk and sound science.
16 I think the desire of the stakeholders to see a
17 comprehensive, qualitative risk assessment
18 conducted required in implementation of any changes
19 in the antibiotics approval process is clear.
20 I guess from our point, speaking
21 not just for the National Turkey Federation, but I
22 know I speak for everyone in the Coalition for
23 Animal Health on this, we would encourage FDA/CVM
24 to sit down with the stakeholders and to see if
25 there's a way this could be done. We are confident
75
1 and hopeful it could be done in a way and
2 fashionably not slow. Also the overall time frame
3 for addressing the antibiotic resistance issue.
4 But I think you would see in a lot of the
5 stakeholders a much higher degree of confidence if
6 such a risk assessment were conducted.
7 Okay. To ADAA Implementation. I
8 think, you know, ADAA covered a lot. I think we're
9 going to focus today, speaking both for the
10 National Turkey Federation and for the National
11 Coalition for Animal Health on the efficacy
12 provisions. That's the core of the bill. That's
13 why we got involved with the stakeholders in
14 pushing for the package. It's clear from the way
15 it was constructed that that was Congress's primary
16 intent. Very briefly the efficacy provisions that
17 we're talking about here are, one, to remove the
18 presumption that multiple field investigations are
19 needed; to replace that assumption with one that
20 either no or one field investigation may be all
21 that is needed in many circumstances. Require CVM
22 to justify more than one field investigation by
23 written order specific to the drug and its intended
24 use. Eliminate efficacy requirements for
25 combination drugs when all of the drugs or active
76
1 ingredients are previously approved and all have at
2 least one claim in the combination. And I should
3 mention that efficacy should still apply when two
4 or more antibacterials are used in combination, at
5 least for the feed and water drugs.
6 So two and a half years after
7 passage, how is CVM doing? How do we, as
8 stakeholders who worked so closely with them view
9 the success record on implementation of this Act.
10 Well, let's start with the good
11 news first. That has to do with the combination
12 drug section which, taken as a whole, appears to be
13 a working exactly as the ADAA's authors intended.
14 I had a chance to read some articles recently and
15 visit with some folks at CVM about that. We're
16 extremely pleased that we have seen, since ADA
17 became law, more than forty combination drugs
18 approved. Roughly 75 percent of those are
19 production drugs. Parochially speaking, the vast
20 majority have been poultry drugs, and even more
21 parochially we're even more pleased that four of
22 them have been combination turkey drugs. We should
23 also mention that there have been several cattle
24 approvals, and we have heard that there are some
25 swine approvals coming down the line. So, you
77
1 know, we think that, on balance, it's working
2 well. I'm not going to say that every application
3 is going smoothly, because I'm sure if I indicated
4 that I would hear from a lot of our pharmaceutical
5 allied members tomorrow with some story. But I
6 think there's every indication that the combination
7 proposals are being looked at to be ensure that
8 combination drugs are being used for appropriate
9 therapy, that there no human safety residue
10 questions involved, and that the answer to those
11 questions are yes to the appropriate therapy mode,
12 and CVM is to be commended and congratulated, in
13 fact.
14 The good news that is tempered in
15 a couple of issues. Dispersal of combination
16 approvals is obviously going to have a limited life
17 span. There's a limited, finite number of approved
18 drugs out there for which these combinations can be
19 used. At some point all of the available
20 combinations will end and we will see the dispersal
21 approvals begin to slow down.
22 That brings us to the question
23 about other provisions. I can't -- when I
24 originally started preparing for this presentation
25 I originally thought we were going to have to take
78
1 a hard look and raise some of the questions that
2 we've raised in previous forums about whether less
3 than three field investigations could really be
4 used in those circumstances. After a while a lot
5 of the anecdotal information that we've had in the
6 past that we've had some problems. There are a lot
7 of old stories. I'm not going to torture you with
8 stories about instances where we've seen turkey
9 drugs slowed by what we think is needless efficacy
10 requirements. But I've got to say this: CVM has
11 apparently completed, at least internally, its
12 report to Congress that was required in the FY '99
13 Agricultural Appropriations Bill. Hopefully very
14 soon we'll see that publicly. We've seen some
15 preferences to date that 78 percent of the
16 applications have been approved at some point by
17 the ADAA. We hope that's accurate. We're going to
18 love to look for it and see how that's counted, how
19 they're measuring these improvements. We hope it's
20 good news.
21 What we've seen to this point has
22 raised a couple of concerns, though. Last October,
23 Congress proposed several questions to CVM in the
24 context of a House Commerce Committee hearing about
25 this very question. One of the answers was really
79
1 disturbing. When they were asked to give the
2 number of ADAAs in which less than three field
3 investigations were used, the first line is, We
4 don't have a field in our tracking system that
5 allows us to measure this accurately. Well, it was
6 pretty clear from the way Congress handled the ADAA
7 that measuring this was going to be pretty
8 important. So let me at least first suggest that
9 perhaps that the tracking system be amended so
10 there is such a field in the future and we can get
11 an accurate measure of this. Because I think it
12 was important to Congress; I know it was important
13 to the coalition, and this is a question that's not
14 going to go away, I think, until we can get an
15 accurate measurement of this.
16 They did report in theirs answer
17 to Congress that there had been at least seven
18 supplemental ADAAs for food animals that had been
19 approved for drugs with less than three
20 investigations. That's encouraging. There was
21 also a claim in the response to Congress that
22 seventeen ADAAs, including nine for food animals
23 that had less than three and sometimes no field
24 investigations.
25 The question I come back to is I
80
1 think a breakdown on exactly how many
2 investigations -- you know, obviously we want to
3 reveal the drug, but in general how many we were
4 talking about would be extremely useful.
5 I think we also have to mention
6 that the substantial evidence regulation, the
7 second major implementing regulation for ADAA, is
8 approximately six months overdue. We recognize
9 this all is not entirely the Agency's fault, but we
10 need to see the regulation at some point. And we
11 are a little curious about the claim that, in part,
12 the delay is we were waiting to see what happened
13 with the arsenical. The omnibus appropriations
14 bill did not pass until October, but the House
15 first action on this was June 10th, and there was
16 every indication from June on that this was going
17 to be part of the bill.
18 I want to endorse what Rich said
19 about compassionate use of INADs. I think there
20 was at least one instance in our industry that this
21 could be have been very useful. This is not just
22 to pick on CVM. I say this to every pharmaceutical
23 company that's here: Please, someone step up and
24 use the binding presubmission conference as it was
25 envisioned in the ADAA.
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1 So finally we've got a handful of