0001 01 01 02 02 03 03 04 04 05 05 06 06 - - - 07 07 FDA MEETING, 08 08 Before Michelle S. Schreadley, 09 Certified Court Reporter and Notary Public, 09 10 At FDA, Atlanta, Georgia, 10 11 On April 28, 1999, at 3:20 p.m. 11 12 - - - 12 13 13 14 15 16 17 18 19 20 21 22 23 24 25 0002 01 April 28, 1999 02 3:20 p.m. 03 MR. DYKSTRA: Folks, why don't we 04 get started with the second or maybe the third 05 part of your program. I want to again thank 06 you for your patience with this process and 07 again assure you that we are going to try to 08 capture all of your questions and comments. 09 And if we have answers, we'll capture those 10 too. 11 We are employing the use of a court 12 reporter, so it will be necessary, if we get to 13 a point where you want to ask a question 14 verbally, if you would stand up and identify 15 yourself for the court reporter, it will help 16 her. 17 What we're going to do first of all 18 with this session of the program is we have a 19 couple of presenters. Nancy Singer from the 20 Health Industry Manufacturers Association has 21 some remarks that she wants and the Association 22 wants to get into the record. And 23 Betsy Woodward, representing AFDO, Association 24 of Food and Drug Officials, has a short 25 presentation as well. 0003 01 Once we get through those 02 presentations, then we are going to, we have 03 distributed many of your questions among us 04 here in Atlanta, and we're going to go through 05 them. I can't guarantee that we have answers 06 for all of them, but some of them, we can at 07 least comment on and help the process a little 08 bit more. 09 And, again, those will be captured 10 in the formal record, and you will see those, 11 as well as hopefully some reasonable answers, 12 on the Internet in the not-too-distant future. 13 So that's what we want to get through this 14 afternoon. Hopefully we can get through it 15 speedily so we can get you all on your way 16 before that traffic starts backing up out 17 there. So let's get on with it. Nancy? 18 MS. SINGER: Thank you. Good 19 afternoon. My name is Nancy Singer, and I'm 20 special counsel to the Health Industry 21 Manufacturers Association, HIMA. HIMA is a 22 trade association in Washington, D.C., and we 23 have 800 members presently. And we represent 24 90 percent of the sales of medical devices in 25 all of the United States, and we feel very tied 0004 01 into the medical-device industry. 02 I'd like to see how many companies 03 are medical-device manufacturers here? Can I 04 have a show of hands? How many food companies? 05 Can I see how many are in the food industry? 06 Nobody left in foods. How about drugs? Two in 07 drugs. Three in drugs. How about members of 08 consumers? Any consumer representatives or 09 doctors? Okay. So there's mostly industry 10 people in the audience, and the rest of you 11 back there in FDA. So this side of the room is 12 industry, and that side of the room is FDA. 13 It's good to see a little bit about the 14 break-up. 15 Well, over at HIMA, and me 16 representing HIMA, really appreciate the 17 opportunity to be here today. And we broke up 18 for the telephone conferences, the different 19 centers or the different sites around the 20 country, and this is the ORA site. So I 21 thought my remarks would focus on what action 22 do you propose to enable FDA's Office of 23 Regulatory Affairs to focus on those areas of 24 the greatest risk to the public health. That's 25 what I'm going to be talking about today. 0005 01 Now, we at HIMA, we believe that 02 FDA has done a terrific job working with 03 medical-device manufacturers in that they've 04 implemented many changes that really have 05 focused the Agency's resources to make the 06 inspection process fairer and more equitable 07 and more efficient. We believe these 08 cooperative efforts really must continue 09 because this will enable patients to have 10 access to safe and effective medical-device 11 technology. 12 Now, let's look at various roles of 13 different agencies in the industry. Really, 14 medical-device manufacturers see ourselves as 15 the innovators in the diagnosis, care, and 16 treatment of disease, and our success really 17 depends on allowing patients access to safe and 18 effective medical devices. So that's industry. 19 Now, let's consider where FDA is 20 coming from. FDA officials also see themselves 21 as the guardians of the public health. Their 22 mandate is to foster the introduction of new 23 technology but at the same time to ensure that 24 devices that are designed to treat patients 25 really do not cause any harm to those patients 0006 01 inadvertently. 02 One of the ways that the inspector 03 FDA does its job is by inspecting our company's 04 medical-device manufacturers. And during the 05 past few years FDA has really viewed industry 06 as a partner rather than an adversary, and 07 we're just delighted by all the wonderful 08 changes that have gone on. 09 This really has not always been the 10 case. I remember when I first came to HIMA in 11 1990, and at the time I was coming to HIMA, 12 Commissioner Kessler, in November of 1990, 13 became the Commissioner of the Food and Drug 14 Administration. And one of the things that he 15 wanted to do, as some of you will recall, is he 16 wanted to take enforcement up a notch. And so 17 he kind of changed the way business was being 18 conducted, and what he did at that time is he 19 said, let's decentralize the power of 20 enforcement. Let's put more power in the 21 individual district offices, and let's keep 22 everybody on their toes. 23 Let's go into a medical-device 24 manufacturer, find deficiencies, cite them for 25 the deficiency and go into another 0007 01 medical-device manufacturer and find other 02 deficiencies. 03 Now, companies looking for 04 consistency and predictability had a big 05 problem with this because we never knew in what 06 area the Agency was going to strike, and there 07 were really no lessons learned because they 08 were going to various companies and finding 09 different things. 10 At that time, again, in the early 11 '90s, HIMA was upset by this, and we said, the 12 environment is not the way we would like it. 13 We figured we would like to figure out ways to 14 make the system work. What we did is polled 15 our members and said, what can we do to make 16 the inspection process better? 17 And basically what we came up with 18 is we wanted FDA to conduct preannounced 19 inspections. We also wanted FDA to annotate 20 483 observations. We wanted them to take these 21 483 observations and put them in context. For 22 instance, I looked at 50 complaints, and I 23 found out that there was follow-up with 24 relationship to three, a lack of follow-up for 25 three, three out of 50, not just a lack of 0008 01 follow-up for complaints. 02 Lastly, the medical-device 03 manufacturers wanted closure. They wanted 04 close-out letters. The Medical Device Industry 05 Initiatives Grassroots Task Force came up with 06 the same suggestions, and FDA did in fact come 07 up with a pilot program where they piloted 08 these initiatives. 09 What FDA did is they took a survey, 10 surveyed the companies. They surveyed the 11 investigators, and they found out this program 12 was really successful, that it worked. 13 Industry liked it. The investigators liked it. 14 So they began to take the program, and they put 15 it as part of their standard operating 16 procedure. And now the program is being 17 piloted in other centers, and we were just 18 delighted. 19 Well, that went really well, so we 20 said, let's get more suggestions. We said to 21 the industry, ask your customers. Ask the 22 people you're doing business with. So we had 23 meetings all over the country, and actually we 24 had a meeting right here in Atlanta. During 25 that meeting we asked industry, what are more 0009 01 suggestions? 02 We came up with a whole lot of 03 suggestions, and one of the suggestions was, 04 let us in fact conduct joint meetings, joint 05 training. Let's have industry and FDA sit in 06 the same room at the same time and learn about 07 the new requirements. Why should FDA be in the 08 corner all by itself? It doesn't make any 09 sense to us. We should all hear the same 10 thing. 11 We said, you know, those 12 establishment inspection reports should be 13 given out. Why should a company have to 14 request those and let our competitor know that 15 they are making the request. Give them out 16 automatically. That way we could find out 17 about the conclusions early and often, and we 18 wouldn't have to request it. 19 Also, we said, let's exclude from 20 warning letters those ideas, those things, that 21 have been fixed. If you go into a company and 22 you take some corrective action, why put it in 23 a warning letter? It's only vindictive, we 24 thought. 25 Another idea, let's increase the 0010 01 time to respond to 483's so we can really 02 correct and have a better response, rather than 03 do it very quickly initially. Then if you let 04 us do that and we don't, mention that in the 05 warning letter, if we do get one. 06 Well, FDA was incredibly 07 responsive, and we were just delighted. In 08 terms of joint training with the southwest 09 region, FDA partnered with industry, and we had 10 joint training on the MDR requirements. We had 11 organized joint training with FDA and industry 12 on the design-control portion of the new 13 quality system regulation. We were just 14 delighted to participate. FDA was in the 15 room. Industry was in the room. The exchange 16 was absolutely terrific. 17 Additionally, FDA now automatically 18 provides EIR's to companies after they're being 19 inspected. Another program is the new warning 20 letter that was alluded to on the 21 teleconference this afternoon. That program is 22 very effective. The industry was very 23 concerned that FDA would not realize this, 24 because every time industry gets a warning 25 letter, the corporate image goes down. The 0011 01 stock price goes down. This is very 02 detrimental. And many times, if companies have 03 corrected the items, getting that warning 04 letter didn't really seem so fair to us. 05 Now, FDA listened to our concerns, 06 and that's the biggest compliment you can pay 07 anyone. They came up with a phenomenal pilot 08 program which will fix the concern. The way 09 this pilot program works is beginning March 29, 10 1999, after a company has a domestic 11 inspection, FDA will go to that company, and 12 they will have 15 days to respond to a 483 13 observation. 14 If FDA is satisfied with the 15 response, and in most instances if a company 16 was a good compliant company, instead of 17 sending out a warning letter, they will send 18 out a postinspectional letter. What the letter 19 will say is basically, you would have gotten a 20 warning letter, but you have corrected or 21 promised to correct those actions. However, if 22 we find at a later date that you have not 23 corrected those actions, done what you 24 promised, we'll take other sorts of regulatory 25 action. 0012 01 But at least when the company has 02 taken corrective action or promised, they will 03 not be getting warning letters in most 04 instances. 05 The same sort of program is in 06 effect as a pilot program for labeling 07 violations and for failure to submit a 510(k). 08 There will be an untitled letter. It will not 09 be a warning letter. We are just delighted by 10 this effort. We applaud FDA for working with 11 industry and trying out this new program. 12 What we learned from the Atlanta 13 site, the question was asked, will these 14 postinspection letters be on the Web, and they 15 said no. It's between FDA and the company. So 16 we're just delighted by that development. 17 Another initiative which we were 18 very delighted by is that after years industry 19 said, there's a lack of consistency among the 20 various districts. One district is doing one 21 thing. Another district is doing another 22 thing. One district is doing another thing. 23 They came back to HIMA, you're 24 making these allegations. Give us data. And 25 the industry would say, we can't give you data. 0013 01 It's anecdotal, and our companies don't want to 02 step forward. FDA said, what do you want to do 03 if you don't give us data? 04 FDA and industry worked as partners 05 with University of California at Irvine to 06 design a device evaluation inspectional survey. 07 And the way this works is, at the end of an 08 inspection, the investigator will fill out the 09 top portion of the survey, talking about the 10 company's name, the investigator's name, 11 whether a 483 was issued. 12 Then the company will have an 13 opportunity to fill out how the inspection 14 process worked. The survey will then be sent 15 to the University of California at Irvine, and 16 although the names of the company and the 17 investigator will be on the survey, when they 18 enter the data into the database, nobody will 19 have access to that data. 20 At the end of six months and at the 21 end of a year, the University of California at 22 Irvine will give us reports talking about 23 what's going on in each of the individual 24 districts. Again, here we will have hard data 25 about what's going on, and industry is just so 0014 01 pleased that FDA is interested in this data and 02 that they're supporting the program and working 03 with us. 04 The last program that I'd like to 05 talk about is QSIT, Quality System Inspection 06 Technique. Years ago industry complained about 07 individual deviations rather than looking at 08 what was good in the subsystems. So FDA and 09 industry worked together, and now there are 10 seven subsystems that have been identified. 11 During an inspection FDA will look 12 at the first four subsystems. If they're 13 working and in place, then FDA will be 14 satisfied. We're very delighted by this 15 program. They piloted it in three districts. 16 The results from the pilot program found that 17 in these investigations companies were very 18 pleased and the investigators were very 19 pleased. So this is another initiative that is 20 going to start the first quarter of the year 21 2000, so we're just delighted. 22 So in conclusion, FDA and industry 23 working together have made tremendous progress, 24 in working together, making this inspection 25 process better for all the parties involved. 0015 01 We believe that this interaction should serve 02 as a model across the Agency, across all 03 programs, to make sure the consumers have safe 04 and effective products. We're delighted with 05 all the good work going on, and we urge FDA to 06 continue. Thank you very much. 07 MS. WOODWARD: Good afternoon. 08 I'm Betsy Woodward, Executive Director of the 09 Association of the Food and Drug Officials, 10 which is a 103-year-old organization of 11 federal, state and local regulatory officials 12 and associated industry, comprising now about 13 700 members. I'm pleased to offer today some 14 of the comments to Docket No. 99N-0386, on 15 behalf of Joe Corby, on behalf of AFDO. 16 I'll make some formal comments, and 17 I'll have comments specifically relating to ORA 18 and the State's working relationship with ORA. 19 AFDO is proud of its tradition in 20 working with federal agencies whose mission 21 parallels ours for developing strategies to 22 resolve and promote public health and consumer 23 protection issues related to the regulation of 24 foods, drugs and medical devices and consumer 25 products. AFDO applauds the openness of FDA 0016 01 and its willingness to seek stakeholder input. 02 FDA requested that stakeholders 03 address five questions, and we provided the 04 following comments to those five questions. 05 The first question was: What actions do you 06 propose the Agency take to expand FDA's 07 capability to incorporate state-of-the-art 08 science into its risk-based decision making? 09 Our response is that AFDO strongly 10 supports decision making based on sound science 11 and improved risk-assessment tools. The FDA 12 can expand its capability by support and 13 utilization of available university and 14 regulatory networks through cooperative 15 activities, not the least of which is the Joint 16 Institute of Safety and Nutrition, JIFSAN, with 17 the University of Maryland. 18 Through appropriate utilization of 19 JIFSAN, FDA should delineate and prioritize 20 public-health issues requiring science basis, 21 particularly those where current science is 22 weak, emerging or in many, many cases 23 nonexistent. 24 JIFSAN in turn should incorporate 25 stakeholders in its own internal setting of 0017 01 priorities. AFDO believes that JIFSAN offers a 02 unique academic partnership that can enrich 03 FDA's decision-making science needs. 04 JIFSAN should also be used to 05 evaluate other science that impacts on the 06 Agency's mission and in doing so should utilize 07 an advisory group which offers a cross-section 08 of FDA's networks with state and local 09 governments, consumer groups and other academic 10 entities. 11 Most decision making is set in a 12 scientific, social, political and regulatory 13 framework, which makes it more important for 14 all of these to be brought to the 15 decision-making table to ensure the necessary 16 buy-in and support of any decision. We cannot 17 operate in a vacuum in any of these areas. 18 We also believe there is a need for 19 FDA to counsel with other regulatory officials 20 from federal, state and local governments 21 regarding their experiences in addressing 22 various food-safety issues. 23 State officials should continue to 24 be utilized by the FDA, using the credentialing 25 process, to provide valuable input into 0018 01 proposed regulations and regulatory-enforcement 02 schemes the agency may utilize to obtain 03 compliance. 04 Additionally, AFDO believes that 05 academia must be continually utilized on 06 advisory committees and work groups which are 07 designed for dealing with particular 08 public-health concerns. 09 It is very important that our 10 scientific messages and decisions be very 11 clear, and we ask the question, do they result 12 in the action warranted? Science and public 13 health is currently rapidly evolving, and it is 14 extremely important that we in the regulatory 15 community be uniform in our message. This 16 requires very, very good communication, which 17 we have seen improving over the past five 18 years, as Nancy Singer so effectively pointed 19 out. 20 The second question was: What 21 actions do you propose to facilitate the 22 exchange and integration of scientific 23 information to better enable FDA to meet its 24 public-health responsibilities throughout a 25 product's life cycle? 0019 01 AFDO has previously testified at 02 public meetings that FDA must be the scientific 03 leader and singular body for dispersing 04 scientific information to government at all 05 levels. AFDO's vision of a national 06 food-safety system recognizes the critical 07 nature of this matter as we continue to promote 08 this concept. 09 Although state and local 10 governments should continue to provide input on 11 products throughout its development and 12 marketing life cycle, FDA needs to be the 13 centralized body for publicizing the final 14 decision on scientific matters. 15 FDA cannot assume this leadership 16 role without the buy-in of the stakeholders. 17 Therefore, it necessitates that FDA develop a 18 forum, perhaps an advisory committee, to openly 19 discuss the issues which arise. The Agency is 20 tending to do this through the use of public 21 meetings, but frequently the notice is short 22 and many who should be involved cannot. 23 FDA needs to look at a wide variety 24 of and a more long-range approach to anticipate 25 issues where public health and science must 0020 01 converge to bring resolution in a 02 decision-making situation. 03 To implement an effective 04 integrated approach to exchange of scientific 05 information of regulatory significance, CFSAN 06 and/or FDA needs to develop a streamlined 07 internal tracking system that will ensure state 08 officials receive timely responses to 09 inquiries. 10 FDA technical staff should be 11 empowered to provide answers without forwarding 12 draft responses through multiple layers of 13 bureaucracy. State officials should be willing 14 to accept a verbal reply, if possible, although 15 FDA must be sensitive to the needs of state 16 officials who may need responses in writing to 17 convince regulated industry or consumers of the 18 regulatory position on an issue. 19 State officials can no longer wait 20 months to receive replies on scientific or 21 technical matters. This is particularly 22 important when dealing with regulatory issues 23 where it involves an interpretation of federal 24 law or regulation because most state laws 25 mirror the federal law. 0021 01 What action do you propose, 02 question No. 3, for educating the public on 03 this concept of balancing risks against 04 benefits in the public health decision making? 05 Articles on risk, written in 06 laymen's terms and giving examples from 07 everyday life, should be used in any FDA 08 documents that are produced for the general 09 public. Certainly analogies have been used by 10 the most effective teachers in our lifetime, 11 and they need to be used in these documents. 12 Only by giving such examples can the general 13 public understand risk as it refers to the 14 safety of food and drugs. 15 FDA public affairs specialists 16 should be encouraged to continue to address 17 health risks and the importance of consumer 18 education with all interested persons and with 19 groups with whom they meet. 20 Furthermore, AFDO supports the 21 formation of state task forces comprised of all 22 public-health stakeholders within that state 23 for the purpose of debate, education and 24 communication. 25 Because the Agency must allocate, 0022 01 this is question four, its limited resources to 02 achieve the greatest impact, what actions do 03 you propose to enable FDA and its product 04 centers to focus resources on areas of greatest 05 risk to the public health? 06 Where there are issues that involve 07 a perception that FDA disagrees philosophically 08 with the industry or category of regulated 09 products, FDA must meet both privately and 10 publicly with these stakeholders to ensure on 11 the record that the perception is incorrect. 12 For example, if the public or some 13 segments of the industry continue to distrust 14 FDA with respect to the regulation of dietary 15 supplements, little headway can be made with 16 respect to ensuring the safety and proper 17 labeling of the products in the marketplace or 18 the development of future products between the 19 Agency and the industry and the consumers. 20 AFDO also encourages FDA to better 21 establish and maintain its communication 22 network with state and local government 23 agencies, and certainly ORA has been a model 24 agency, model group within the agency, to do 25 this. 0023 01 On occasion FDA regional and 02 district guidance or response to state and 03 local governments differ from what the FDA 04 centers are saying. This results in a confused 05 message for state officials. AFDO suggests 06 that further development of field-coordinator 07 positions in sensitive high-risk areas, such as 08 product recalls and FDA epidemiological 09 investigations, so those individuals can serve 10 as singular contacts during serious events. 11 Question No. 5, because the Agency 12 wants to assure that stakeholders are aware of 13 and participate in this modernization, what 14 additional actions do you propose for enhancing 15 communication processes that allow for ongoing 16 feedback and/or evaluation of our modernization 17 efforts? 18 AFDO supports the continuation 19 and/or the development of work groups to 20 provide necessary feedback and evaluation of 21 serious health matters. Nancy Singer just 22 presented several to us. AFDO hopes FDA can 23 continue to fund the activities of such groups 24 as the National Integrated Food Safety System 25 Work Groups, the FDA/AFDO Recall Work Group, 0024 01 the Foodborne Outbreak Response Coordination 02 Group, the FoodNet and others established to 03 coordinate and better utilize government 04 resources at all levels. 05 The Office of Regulatory Affairs, 06 which our meeting specifically focuses on 07 today, holds a special relationship with state 08 officials. ORA represents the field, the field 09 offices, field personnel, the field 10 laboratories, and in other words, they're our 11 closest contact with state and local food and 12 drug safety programs. 13 AFDO is supporting right now an 14 initiative for integrating of resources for 15 food safety. This means more and improved 16 communication, coordination and interaction is 17 going to be essential. 18 Currently many may not realize that 19 the Office of Regulatory Affairs has sponsored 20 and implemented and is using joint planning 21 with state officials, whereby meetings are 22 held, and workload within that particular 23 jurisdiction is discussed, and plans are made 24 for how the coverage is going to be made with 25 respect to food safety in those industries. 0025 01 We also participate in joint 02 investigations where both federal and state or 03 local officials go into an establishment for an 04 investigation. This proves to be very 05 beneficial because, though the laws are very 06 similar and requirements of the law, if 07 administrative and enforcement powers are 08 different between the federal and states, then 09 the states do have embargo authority, which we 10 can use in a joint investigation. 11 ORA has developed partnerships with 12 the states where a state has an industry fully 13 under control. Then we develop a partnership 14 where we share information, FDA maintains an 15 oversight, and the state then can carry on that 16 particular activity. In Florida, for example, 17 we have this on our farms for pesticide 18 residues, and it has resulted in the 19 elimination of duplication of efforts between 20 state and federal agencies and much better data 21 sharing between the two. 22 Integration, as I mentioned, 23 requires a strong relationship between the 24 state programs, with our representatives at 25 AFDO and the Office of Regulatory Affairs. In 0026 01 addition to the field activities I've talked 02 about, we also utilize laboratories, and 03 exchange analysis, and many of our analysts 04 have been training in laboratories up here. 05 The training branch is located 06 within the Office of Regulatory Affairs. Part 07 of the opposition to more fully integrating the 08 food-safety system is that some states don't 09 have officials who are well enough trained to 10 do the work at an equivalent level to the FDA. 11 That's a training issue, and we're 12 partnering with the FDA to develop those types 13 of training initiatives that will ensure 14 adequate inspectors and well-trained 15 inspectors, even for those states that lack 16 resources to be able to do that. 17 Obviously we are working shoulder 18 to shoulder, and this requires endless 19 communication, and ORA, through its federal and 20 state relations division, is always developing 21 new and better tools for communication to 22 states. 23 Many years ago we used to only hear 24 about issues on Friday afternoon or when the 25 media, local media, called our office. But now 0027 01 with the new communication mechanisms that have 02 been implemented by the Office of Regulatory 03 Affairs, FDA is keeping us abreast of emerging 04 issues. We have moved from minimal 05 communication at the federal level to a very 06 close partnership of sharing, and ORA has led 07 the way. 08 Again, AFDO appreciates the 09 opportunity to comment on these very important 10 matters. Thank you. 11 MR. DYKSTRA: I appreciate the 12 words from both Betsy and Nancy. They are 13 trying very hard to work with our state, our 14 constituent groups, all those people that have 15 a vested interest day in and day out for what 16 FDA does. You don't want to get into a 17 situation where we have to begin to take or 18 think about taking some sort of regulatory 19 action. That's what we're all trying to 20 prevent. 21 I often tell people that the basic 22 mission of FDA is to get good products on the 23 market and get bad products off the market. 24 And obviously we want to be engaged more in the 25 former rather than, well, we want to be equally 0028 01 engaged in both activities. We want to make 02 sure that there are good products out there at 03 all times. 04 So what we want to do now to 05 continue the program is take a look at some of 06 your questions, and myself, Joe Baca and 07 Ballard Graham, we've divided up the questions 08 that you've submitted. Some of those questions 09 actually got answered on air, so we won't try 10 to answer those questions again or offer any 11 divergent viewpoint. They've already been 12 answered by our headquarters folks. 13 So what I want to do is I'll take a 14 crack at the first one here, and we can, we'll 15 alternate around. And if you want to interrupt 16 at any time and ask some questions that didn't 17 occur to you during the course of the 18 broadcast, feel free to do that. 19 The first one that I want to take a 20 crack at comes from Sharon Harris here in the 21 front from the American Red Cross. She asks or 22 says that the annual meeting held in New 23 Orleans, and I take it that was an 24 FDA-sponsored meeting with the blood industry, 25 with FDA and the blood manufacturers is very 0029 01 informative and beneficial. Would it be 02 possible to conduct a similar meeting on a 03 local level? And I assume what you mean at 04 different local levels around the country in 05 different cities. 06 I think that we, FDA, is very 07 interested in doing this sort of thing. 08 Sometimes it's a matter of resources, trying to 09 do these. And we try to do them in such a way 10 that we get the broadest possible coverage. 11 But this is something that will be answered by 12 both ORA, as well as the center for biologics 13 has an interest in this as well. 14 But I think it's a good question, 15 and I think it's something that we probably can 16 address and maybe address more on the local 17 level so that we can have more of these kind of 18 meetings. 19 And the second part is: What is 20 the plan to expand FDA inspections into 21 transfusion services? 22 MS. HARRIS: Hospital transfusion 23 services. 24 MR. DYKSTRA: That's something 25 we'll have to refer to the center of biologics 0030 01 because they're directing most of the programs 02 in terms of the inspection. And whether they 03 want the field people to do more inspections in 04 those kind of services tends to be more their 05 call than our call. But this question will be 06 directed to them, and they'll have to answer 07 it. So we'll see what they answer with. 08 MS. HARRIS: Thank you. 09 MR. DYKSTRA: Joe? 10 MR. BACA: The question I have is: 11 How is FDA planning to address dissemination of 12 information regarding dietary supplements, 13 herbal drugs, homeopathic products? 14 I will say that, as far as dietary 15 supplements and herbals, our web site is a 16 great source of information for all that kind 17 of material. The other place that is a good 18 source is our public affairs specialist. Every 19 district has a public affairs specialist, and 20 they're available by telephone. And they have 21 a great deal of information at their fingertips 22 that they can provide to a consumer or the 23 industry. 24 The consumer magazine has run a 25 number of articles on these kind of products, 0031 01 and they're all out there and available 02 probably through the web site. But there is a 03 great deal of information out there. Of 04 course, the information is coming to light 05 daily, and so we may not be right on the 06 cutting edge. But there's a great deal of 07 information already there. 08 Some of the products that are known 09 to cause problems are included, as well as some 10 of the less obvious ones. 11 MR. DYKSTRA: Ballard? 12 MR. GRAHAM: I have an interesting 13 one here. It says the drug manufacturers claim 14 that with the high cost of getting a new drug 15 product through FDA directly impacts the market 16 and drug costs to the consumer. With the 17 growing number of uninsured in America, what is 18 FDA's plan to limit or control the cost of new 19 drug processes? Remember often the end 20 consumer must decide if they can afford a 21 product or not, even though the product may 22 best help the patient. 23 This was one we're certainly going 24 to refer up, but I'll take a crack at answering 25 some of this. I know that we have made some 0032 01 improvements in the way we're processing the 02 drug approval process, and we try to control 03 costs that way. 04 Of course, the industry is kicking 05 in some funds to help with that process as 06 well. I think we sped up that process in 07 trying to get those things through a lot 08 quicker, although the consumer, I think all of 09 us want a certain amount of information or a 10 certain amount of review done on products when 11 they come through for a new drug or something 12 like that for use with the consumer. 13 The result is out here. 14 Bob Coleman is a resource. He deals with us a 15 lot on these. Do you have anything to deal 16 with that? 17 MR. COLEMAN: No. 18 MR. GRAHAM: We'll certainly refer 19 to headquarters for additional information on 20 this. 21 UNKNOWN SPEAKER: One other thing 22 on that is in prior years the agency has been 23 real big on the generic drug issue, and we have 24 listed generic drugs that have got a patent 25 expiration on it, but it has really lowered the 0033 01 prices on a lot of prescription drugs. And we 02 put a priority on doing those inspections and 03 getting those drugs marked. 04 MR. GRAHAM: That's true. 05 MR. DYKSTRA: Before I get to the 06 next written question, are there any questions 07 or comments from the audience? Okay. The next 08 question comes from John Ostrander, and his 09 question is: Traditionally drug definitions 10 have included USP, NF and homeopathic 11 pharmacopeal products. The homeopathic 12 pharmacopeal products are not mentioned on the 13 list of drugs pharmacies will be allowed to use 14 for compounding. Are there plans to revisit 15 this item and add the homeopathic pharmacopeal 16 drugs to the list of approved drugs for 17 compounding? 18 It's a very complicated issue in 19 terms of what pharmacists and pharmacies are 20 going to be allowed to compound in their own 21 practices. The agency is charged with 22 identifying specific compounds, specific drugs 23 that pharmacists will be allowed to utilize to 24 compound drugs based on a physician's script, 25 prescription. 0034 01 Now, what has happened though is we 02 were proceeding along in doing that and 03 developing the list, as John mentions here, but 04 the, we have been sued over this whole issue of 05 compounding. And the issue has kind of come to 06 a screeching halt while we're waiting for this, 07 some of these compounding issues to be 08 litigated to see if, you know, the law, number 09 one, is constitutional and, number two, you 10 know, meets all the other legal challenges. 11 So that's likely to drag out as we 12 all know. You know these things tend to drag 13 on in court. Meanwhile, we don't get the 14 answers, all the answers that we would like to 15 this. You know, the things that Congress 16 intended us to do will not be done as 17 expeditiously as most people would like. 18 On the issue of including 19 homeopathic products in the compounding list, 20 that's something that the center is and was 21 considering. We'll have to see. We'll forward 22 this question in and see if those products are 23 going to be included in the list when and if 24 that list ever becomes reality. So we'll see 25 what happens in that area. 0035 01 Another one, Joe? 02 MR. BACA: This is a question from 03 Betsy Woodward. FDA is looking at stronger 04 integration of food-safety programs from the 05 federal, state and local jurisdictions in order 06 to leverage all available resources to maximize 07 effectiveness. Where are we with respect to 08 bringing all of the stakeholders, industry, 09 consumer groups and academia, into discussion? 10 I think the bringing it into state 11 and local groups is kind of getting under way. 12 We have had two national meetings. We had one 13 last December, and I think the previous one was 14 in September. And that is a new concept, and I 15 think we're working our way through it. 16 On the other hand, we have 17 traditionally worked with the industry, 18 industry groups, individual companies. For 19 example, when an industry, a company, is going 20 to open a new facility, we have provisions in 21 our procedures that allow us to go in, look at 22 blueprints, discuss with the firm, you know, 23 how they're going to proceed and how they're 24 going to make the facility so that they don't 25 run afoul of the regulations with the law. 0036 01 I think what's going to happen in 02 the future, if I can look that way, is we're 03 going to see more of that kind of interaction. 04 I don't think we'll go back in the other 05 direction. This is going to go back to our 06 headquarters and be made aware that these 07 concerns exist. 08 MS. WOODWARD: We've actually met 09 with the consumer activist groups, which are 10 really unhappy that they hadn't been included 11 in some of the discussion groups, and we told 12 them, the regulatory people that I knew, what 13 FDA would have on there. 14 MR. BACA: One thing at a time. 15 Bring the state and locals in first, and then 16 span our horizons from there. 17 MR. DYKSTRA: Okay. Next question 18 is from Peggy Davis, has to do with the 19 inhalation of fragranced products which are 20 known to trigger migraines and asthma. The EPA 21 names the use of chemically formulated personal 22 care products along with pesticides and 23 household cleaners as contributors to indoor 24 air pollution. How do you propose to raise 25 public awareness of possible health risks from 0037 01 the use of these products? 02 This is a, it's a difficult 03 question. It's one that Peggy has raised with 04 us previously. It's something that we are 05 going to refer to our cosmetics people in 06 particular, and it's also one that, you know, 07 as she points out, is an EPA issue as well. 08 So we've got to see what, if 09 anything, the Environmental Protection Agency 10 is doing on this issue. So this is one, again, 11 as promised, it will go on the web site with 12 the response that will come primarily from our 13 headquarters folks. So we'll see how they deal 14 with it and see where we go from there. Do you 15 have any others, Joe? 16 MR. BACA: I have one more. With 17 this one maybe we can have more dialogue. As 18 regulators maybe we don't realize there's a 19 problem. This is submitted by David Mullis of 20 London International. The question is: How 21 and when do you see FDA's role and 22 responsibility being clarified with that of 23 OSHA in the area of medical devices? 24 I guess my thinking was I never 25 knew we had that big of a problem. OSHA's role 0038 01 is certainly to protect the health of workers, 02 and our role is more geared toward the patient. 03 But maybe we need to address that issue some 04 more. Is Mr. Mullis here? Yes, sir. 05 MR. MULLIS: There are certain 06 devices, particularly those that deal with 07 latex products, that you have got FDA that has 08 the premarket clearance authority quite clearly 09 delineated. But I think of OSHA as a safe 10 working environment and responsibilities in 11 terms of enforcement of that type of thing. 12 And sort of like the previous 13 question, as it gets into, you know, risk to 14 the environment, risk to the patient, risk to 15 the people around, there is obviously more and 16 more concern as to who has the authority and 17 what role is there. 18 I think a letter back in December 19 came out talking about where FDA was going to 20 allow more and more authority through OSHA for 21 inspection kind of activities at the hospital 22 setting. And obviously that, it's stuff that 23 is not clearly defined, and those of us in the 24 industry have some degree of anxiety about it. 25 MR. BACA: Latex is a big problem, 0039 01 and with the infiltration of the use of gloves, 02 I think it's more of a problem. Both of those 03 will help address us on this issue. 04 MR. DYKSTRA: I think there 05 currently are perhaps more than one work group 06 looking at the specific issue of latex, and 07 those kind of materials that can cause 08 reactions in people, are sensitive to different 09 materials. Whether it's gloves or just 10 handling other types of biomaterials can cause 11 problems for these people. That's all the 12 questions that I have. 13 MS. WOODWARD: I have one question. 14 Do you put your work groups out on the web site 15 so interested individuals who want to 16 participate in them can ask your industry? FDA 17 work groups, are they listed somewhere on the 18 web? 19 MR. DYKSTRA: Not to my knowledge. 20 MS. WOODWARD: It might be a good 21 thing to do. It might give the Agency a sense 22 of more openness. Really, I think that would 23 probably be a good thing to consider at least. 24 MR. DYKSTRA: Because, you know, we 25 do have work groups all over the place. 0040 01 MS. WOODWARD: I know. There are 02 some that are more interesting to the industry. 03 MR. DYKSTRA: It would be a good 04 way to identify issues. Usually when a 05 difficult issue comes up, it takes more than 06 one person to take a look at it. 07 MS. WOODWARD: Absolutely. 08 MR. OSTRANDER: I want to put this 09 on as a consumer issue. But recently I was 10 very, very surprised to have a new fellow 11 employee come to me and say they were an 12 asthmatic. They were recently under the HMO 13 that we had at work, and albuterol was 14 generically substituted for Proventil. They're 15 supposed to be generic substitution, and that 16 if it's not in the orange book listed, you 17 shouldn't have gotten it. 18 Well, I was wrong. When I 19 discussed this with the pharmacy people in 20 terms of substitution, if the product is out 21 there on the market labeled as U.S.P., 22 presumably because that's what it was, that 23 there is no requirement for bioequivalency to 24 the product the physician may have originally 25 prescribed for the pharmacies to substitute 0041 01 these things. At least this is what I was led 02 to believe from the pharmacist when I spoke to 03 him on the phone. 04 I think what might be needed would 05 be some clarification to those of us who may be 06 practitioners in the practitioner setting as to 07 exactly what the criteria are for generic 08 ratings in terms of the orange book listing and 09 where that rating is not necessary for the 10 generic product to get marketed. 11 Because I was just blindsided from 12 this thing, and I was very surprised to see 13 this. 14 MR. DYKSTRA: I don't have a 15 specific answer to that, but we'll capture that 16 as a question and pose it to the people who are 17 more expert on it. Other questions or 18 comments? 19 MR. LAWRENCE: I've got a 20 statement. I'm Mallory Lawrence. I'm with the 21 FDA. I'd like to see, Betsy, this is kind of 22 directed to you. We've had an excellent 23 working relationship with AFDO, the local 24 organization, and AFDO overall. But I think, 25 and when we work with them on other programs to 0042 01 try to bring the seafood industry, this is 02 seafood industry, into compliance, I'd like to 03 see AFDO go one step further. 04 Because one of the shortfalls we've 05 got, one of the problems we've got in the 06 seafood industry is the industry is small in 07 the southeast, and they're not regulated by 08 most standards. I think what's needed is for 09 AFDO to promote and AFDO to maybe carry out to 10 facilitate specialized training in fields that 11 there are not very many trainers located in. 12 For instance, the pasteurization 13 process, salting, smoking. I think if AFDO 14 would work with the universities and put on 15 specialized training, I think that's the next 16 step that needs to be taken. 17 We've already done the training, 18 and we're working further on that. Now, a 19 little bit of technical knowledge will go a 20 long way, and I think this will, I think that's 21 a need. And I don't think that the experts who 22 wrote that are doing, at least at the wholesale 23 level and into the three states that we've got, 24 and not only can you provide training to 25 industry, but you can train, you could provide 0043 01 training on specific technical issues to the 02 states, health and agriculture, as well as to 03 us, our people too. 04 So I think that's the next step to 05 consider where you would offer valuable 06 assistance to industry and FDA and the states 07 alike. 08 MS. WOODWARD: AFDO has a big 09 training thrust right now, and we are seeking 10 grant money to do just some of the things 11 you're talking about. We're going to have to 12 do it through some kind of a grant. Right now 13 we're looking at trying to get a grant for 14 smoking, curing in the sausage, smoked and 15 cured hams. That's going on in retail that are 16 not covered. 17 We are also doing some training in 18 imports with trying to partner with Nancy's 19 group in doing some medical-device regulation 20 training. So we are looking at more and more 21 training. 22 As much as possible, we're doing 23 that with AFDO's resources. But like FDA we 24 don't have a lot of resources. So we're now 25 learning to write grants. I'd like to go on 0044 01 the Hill to Congress and say, please give FDA 02 funds similar to what U.S.D.A. has, where you 03 can partner with associations, not just AFDO, 04 but national, city and county health 05 organizations, to accomplish some of these very 06 needed things in the food-safety arena. 07 MR. DYKSTRA: You know, we can 08 direct that question and comments right back at 09 FDA, and particularly to the center, to direct 10 some of that, some of their money their 11 food-safety money, to people that could put on 12 that kind of training, whether it's directed to 13 AFDO or directly to universities and others who 14 put on that. 15 MS. WOODWARD: I think we partner 16 with a university and take it through regions 17 to get it across the country on a 18 cost-effective basis. 19 MR. DYKSTRA: Right. Other 20 questions or comments? Well, again, I want to 21 remind you that all of this is going to appear 22 on the web, including a web cast for the next 23 30 days, of what you saw today, so you can look 24 at it again if you thought you missed 25 something. 0045 01 And I'll also remind you that there 02 is a formal docket for this that you can get 03 from Joanne, and you can, if you have any 04 questions later that occur to you, you want to 05 get them in, you can either submit them 06 directly or get them to Joanne, and we'll get 07 them into the docket. 08 Okay. Thank you for joining us 09 today. It's been very helpful, and I think 10 we've all learned something. Thank you. 11 (Meeting adjourned at 4:15 p.m.) 12 13 14 15 16 17 18 19 20 21 22 23 24 25 0046 01 C E R T I F I C A T E 02 GEORGIA 03 COBB COUNTY 04 I hereby certify that the above and 05 foregoing pages 1 through 46 are a true, 06 complete, correct and exact transcript of 07 my shorthand notes taken in the 08 above-referenced matter; 09 That same constitutes a true, 10 complete, correct and exact record of the 11 above-referenced matter; 12 That same was transcribed through 13 computer assisted transcription; 14 That I am not of kin or counsel to 15 any of the attorneys or parties, nor am I 16 in the regular employ of any of the 17 attorneys or parties; 18 This __________ day of 19 _________________________, 1999. 20 20 21 21 ______________________________________ 22 MICHELLE S. SCHREADLEY, CCR B-1504 22 Certified Court Reporter 23 and Notary Public. 23 24 24 25 25