> U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
>
> FOOD AND DRUG ADMINISTRATION
>
> FDA STAKEHOLDER MEETING
>
> TALKING WITH STAKEHOLDERS ABOUT
>
> FDA MODERNIZATION
>
> Wednesday, April 28, 1999
>
> 12:50 p.m.
>
> The Jefferson Auditorium
>
> U.S. Department of Agriculture
>
> 14th and Independence Avenue, N.W.
>
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> Introductory Remarks
>
> Michael Friedman, M.D.
>
> Deputy Commissioner for Operations 4
>
> Interactive Satellite Teleconference 9
>
> Opening Remarks
>
> Robert Byrd
>
> Deputy Commissioner for Management and
>
> Systems 10
>
> Stakeholder Panels
>
> Panel 1:
>
> Tony Young, American Herbal Association 12
>
> Ann E. Fonfa, Annie Appleseed Project 17
>
> Eleanor Vogt
>
> National Patient Safety Foundation 25
>
> Jama Russano
>
> Children Afflicted by Toxic Substances 29
>
> Questions or Comments 37
>
> Panel 2:
>
> Bert Spilker, Ph.D., M.D., PhRMA 41
>
> Dana Kuhn, Committee of Ten Thousand 47
>
> Anita Ducca
>
> Coalition for Regulatory Reform 51
>
> Sanford Chodosh, M.D.
>
> Public Responsibility in Medicine and
>
> Research 58
>
> Questions or Comments 64
>
> Panel 3
>
> Michael Doneo, People\'s Medical Society 67
>
> Susan Cohen 74
>
> Brian Meyer
>
> American Society of Health Systems
>
> Pharmacists 83
>
> Questions or Comments 90
>
> Closing Remarks
>
> Sharon Smith Holston
>
> Deputy Commissioner for External Affairs 100
>
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> DR. FRIEDMAN: I want everything to remain on schedule today as much as
> we can. I\'m Mike Friedman. I serve as the Deputy Commissioner in the
> Food and Drug Administration and on behalf of two others I\'d like to
> welcome you here. One is Deputy Commissioner for International and
> Constituent Relations, Sharon Holston, and the Deputy Commission for
> Management Systems, Bob Byrd. We are glad that you can participate in
> this the Washington, D.C. site of the downlink for this teleconference
> with Dr. Henney.
>
> We think today will be a special event. We want to give you an
> opportunity to directly share Dr. Henney\'s vision for the future of
> the Food and Drug Administration. This is designed to give FDA
> stakeholders a chance to tell the agency what they\'re thinking. In
> addition to the two-hour teleconference, the agency is sponsoring
> separate meetings in major cities across the country from Boston to
> San Diego. At each of these sites, like the meeting here today,
> stakeholders will be given a chance to provide their concerns and
> provide feedback on five questions that have been published in the
> Federal Register announcement that form the central topics for
> today\'s events.
>
> This process of talking to FDA stakeholders is laid out in the FDA
> Modernization Act and we take this very seriously. We started these
> meetings last summer, and they have provided a valuable source of
> information for the agency. Let me tell you what\'s planned here
> today. We\'ll start with a teleconference with Dr. Henney and with Dr.
> Suydam. The U.S. Senate confirmed Dr. Henney, as you know, last fall,
> and she became the Commissioner in November. While she\'s been meeting
> throughout the agency, industry and consumer groups since that time,
> this is the first time that she\'s holding a nationally broadcast
> interactive teleconfernece.
>
> Dr. Suydam is the Senior Associate Commissioner for FDA. She
> coordinates a large number of activities within the Office of the
> Commissioner and she directly supervises the chief mediator and
> ombudsman staff, the Office of the Executive Secretariat, the Office
> of Public Affairs, the Office of Orphan Products, Internal Affairs
> staff, advisory committees oversight, and the Office of Tobacco
> Programs.
>
> The first half of the teleconference is slated to be an opportunity
> for Drs. Henney and Suydam to provide their vision for FDA over the
> next several years. The second half of the teleconference will provide
> an opportunity for you, the audience, to call into the FDA TV studio
> or to send faxes and direct your questions to them on the air.
>
> This conversation is intended to focus on five critical questions that
> have been laid out in the Federal Register. You know what those
> questions are. Number one: what actions do you propose the agency take
> to expand FDA\'s capability to incorporate state of the art science
> and risk based decision making?
>
> Number two: what actions do you propose to facilitate the exchange and
> integration of scientific information to better enable the agency to
> meet its public health responsibilities?
>
> Number three: what actions do you propose for educating the public of
> balancing risks and benefits in public health decisions?
>
> Number four: what actions do you propose to enable FDA and its product
> centers to focus resources in areas of greatest risk to the public
> health?
>
> And number five: what conditional actions do you propose for enhancing
> communication processes that allow for ongoing feedback and/or
> evaluation and evolution of our modernization efforts?
>
> You can certainly submit these comments or questions on any of these
> areas during the teleconference. If you want, there will be phones set
> up here for you to call the TV studio during the second half of the
> teleconference and direct your questions to them. Please, however, I
> ask you limit your questions to these topics. As many other
> interesting and important items as I\'m sure you want to bring to
> their attention, we ask that today you only deal with this handful of
> subjects.
>
> After the teleconference is over, we\'ll take a short break, and then
> we\'ll begin a two hour meeting here in this auditorium. Perhaps a
> dozen or so individuals representing various FDA stakeholders have
> registered to speak. We look forward to hearing from them. There are a
> number of FDA officials here at this meeting who will form a panel and
> listen to those questions and comments. This is not really a question
> and answer system. Primarily this is an opportunity for us to hear the
> kinds of concerns, suggestions, comments and advice coming from our
> stakeholders.
>
> The discussions\--if our equipment permits \--will be recorded and
> transcribed and entered into a general database of information being
> assembled from similar meetings all across the country. Questions that
> are not answered during the teleconference will be grouped into
> categories and answers will be provided on our internet site and
> subsequently in reports to Congress.
>
> As I\'ve said before, this is an important process. We take it
> seriously. We face a number of very important challenges as we enter
> the next millennium. Our responsibilities grow faster than our
> resources. The current budget request before the Congress provides for
> a substantial increase for the agency, but even so there will be
> responsibilities that we cannot fully meet because we do not have all
> the resources.
>
> In addition, science progresses at an accelerating rate. The agency
> must strengthen its scientific base if it\'s to remain current with
> the scientific advances and make the decisions required before us.
> These are challenging times. They\'re also enormously exciting times.
> I hope that you will find this teleconference interesting, informative
> and valuable. We very much look forward to your discussions
> afterwards. Thank you all very much. I anticipate that in the next
> couple of minutes, the teleconference will begin. In the meantime,
> welcome again.
>
> \[Interactive satellite teleconference convened for two hours followed
> by a short break.\]
>
> MR. BYRD: Dr. Friedman has already introduced me. I\'m the Deputy
> Commissioner for
>
> Management and Systems with the Food and Drug Administration. We want
> to continue our stakeholder meeting this afternoon. These stakeholder
> meetings will be listening meetings as Dr. Friedman indicated. We\'ll
> be listening to 11 speakers representing three panels. We will
> continue our discussion on the Food and Drug Administration\'s
> Modernization Act and what we\'re doing to implement the act.
>
> You\'ve heard what the five questions are over and over again, but I
> think they deserve just one more reiteration by me. The five
> questions: (1) what actions do you propose the agency take to expand
> FDA\'s capability to incorporate state of the art science into its
> risk-based decision making; (2) what do you propose for educating the
> public about the concept of balancing risks against benefits in public
> health decision-making; (3) what actions do you propose to facilitate
> the exchange and integration of scientific information to better
> enable FDA to meet its public health responsibilities throughout a
> product\'s life cycle; (4) what actions do you propose to enable FDA
> and its product centers to focus resources on areas of greatest risk
> to the public health; and the last question, what additional actions
> do you propose for enhancing communication processes that allow for
> ongoing feedback and/or evaluation of our modernization efforts?
>
> As I\'ve indicated, we have 11 speakers. The 11 speakers have all been
> given an agreed upon time to make their presentations. We ask that the
> speakers adhere to these times because we want to be fair to all of
> those who\'d like to speak so we ask you to be very cognizant of the
> time frame under which we\'re operating.
>
> Our first panel today I\'d like to introduce is Tony Young, who is
> counsel for the American Herbal Products Association; Ann Fonfa from
> the Annie Appleseed Project. Ms. Fonfa is a breast cancer patient and
> advocate. Eleanor Vogt is from the National Patient Safety Foundation.
> And Jama Russano is from the Children Afflicted by Toxic Substances.
> Who would like to go first? Tony Young.
>
> MR. YOUNG: My name is Tony Young. I\'m counsel for the American Herbal
> Products Association, the national trade association and voice of the
> herbal products industry. AHPA is comprised of small and large,
> domestic and foreign companies doing business as importers, growers,
> processors, manufacturers of herbal products. We are the principal raw
> materials supplier, manufacturer, and distributor beneficiaries of the
> Dietary Supplement Health and Education Act\'s inclusion of herbs and
> other botanicals within the definition of dietary ingredients. We
> appreciate the opportunity to provide input here with respect to
> FDA\'s modernization efforts.
>
> On state of the art science and risk-based decision making, we support
> the concept of risk-based decision making and the incorporation of all
> available science including state-of-the-art science into that
> process. In 1997, AHPA published the Botanical Safety Handbook which
> forthrightly describes conditions appropriate for the marketing and
> use of many herbs including potential adverse effects.
>
> This handbook was based on the rich worldwide experience, tradition
> and reporting on the effects of herbs. We see that handbook as a
> takeoff point. The first edition of an information base and source
> that will be edited from time to time to include new and important
> information as it appears. AHPA and its members do not seek to hide
> from what is known about the safe use of herbs and botanicals. AHPA
> recognizes that many herbs are pharmacologically active and must be
> treated with respect.
>
> We encourage FDA to provide information to AHPA as it becomes
> available so it can be considered for inclusion in the safety
> handbook. AHPA also recognizes that many of its products are used to
> treat conditions which FDA so far has said must be described
> euphemistically. \"For men over 50 years old\" sounds to us like a
> 1950s laxative TV commercial where the only word over three syllables
> permitted by TV sensors was \"regularity.\"
>
> Saw palmetto is used by many men who experience enlarged prostate, a
> condition as common to male aging as gray hair. The National Institute
> of Aging for one of our institutes has an excellent information piece
> of BPH including clear and concise descriptions of the signs and
> symptoms of BPH and the universally accepted message that those with
> BPH should see a physician.
>
> State of the art science says men over 50 should have a prostate exam.
> Eight out of ten cases are simply enlarged prostate and two are much
> more serious. Is there any good and sufficient reason why the essence
> of those NIH authored statements, neither of which mentions saw
> palmetto, should not be included within saw palmetto packages so that
> men who have this condition can have the opportunity to ready them?
> Isn\'t that good sense, good risk reduction and good science?
>
> With respect to the exchange and integration of scientific
> information, we encourage FDA to promptly exchange scientific
> information with the botanical industry. When the plantain
> contamination situation occurred, some real science heroes in FDA\'s C
> Street laboratory did an extraordinary job in determining the
> contaminant and its source. FDA presented its position to industry and
> the industry, herbal products industry, cooperated in effectuating a
> recall.
>
> We need that kind of interchange. Recently, an article in the American
> Family Physician reported on five botanicals which may interact with
> prescription meds. AHPA intends to address this information. We
> encourage the pharmaceutical manufacturers to address this
> information. FDA can play an important role by bringing articles like
> these to the attention of the herbal products industry so that we can
> integrate it into our database and recommendations for members.
>
> We encourage FDA and staff to share technical input to industry
> efforts. In this regard, we point out the value of having FDA staff on
> an open seat of the Institute for Nutraceutical Advancement, that is
> presently developing validated scientific methods, analytical methods,
> for botanicals. Those aren\'t necessarily in place yet and we know we
> need to get them and FDA knows that we need them as well.
>
> With respect to areas of greatest risk, botanical raw material
> identification, as the plantain incident showed, is a very important
> area and it\'s the first step to ensuring the integrity of botanical
> products. FDA scientists are now working with AHPA and the American
> Herbal Pharmacoepia to provide training to members of the botanical
> products industry in basic botanical morphology and microscopy.
>
> This follows the submission by AHPA members to FDA and its advisory
> committees of a botanical identification scheme. FDA input into these
> kinds of industry efforts focuses resources in an important area where
> our industry already has a momentum going and where we can both serve
> the public interest.
>
> Enhancing communication about modernization efforts, we encourage FDA
> to interact with AHPA members, staff, counsel, whenever there are
> matters of interest to be discussed. AHPA has taken the initiative of
> inviting FDA staff to our committee meetings, and we are pleased to
> have them present at those meetings. Modernization should also include
> open lines of communication. Passing along information to affected
> industry should not be considered engaging in policymaking. FDA and
> its staff should not be so shy that they cannot informally communicate
> information to the industry it regulates so that we can begin promptly
> to take action where necessary. Thank you very much.
>
> DR. FRIEDMAN: Thank you.
>
> MS. FONFA: My name is Ann Fonfa. I was diagnosed with Stage 1 invasive
> lobular carcinoma in the left breast January of \'93. I found it while
> doing my monthly breast self-exam. I chose not to have radiation after
> the lumpectomy. Dealing with a very slow growing cancer, I also chose
> not to take chemotherapy. I knew that most breast cancer patients in
> common with many other cancer patients did not benefit in survival
> terms. I\'ve spent the last six years educating myself on issues of
> importance to the cancer patient community.
>
> I speak for myself and a large number of cancer patients concerned
> about treatment options and standards. We need to know about all the
> trials that are available. The PDQ is way too limited. We want you to
> make the information available on all trials to all of us. There are
> no secrets among the industry. Let us into the club.
>
> We also want you to publish mortality data. This is very important
> information for cancer patients. It\'s what we care about. Give us
> access to drug data before we\'re asked to comment on approval for a
> particular drug. We want to focus on relevant issues. We need the
> facts. Let us meet and speak to FDA officials informally before a
> meeting. We have lots of questions. We don\'t understand very much
> about your agency. We need to know.
>
> Oncologic advisory meetings can be confusing and intimidating. When a
> speaker raises issues, they\'re not necessarily responded. There is no
> dialogue. The audiences in the back of the room sometimes cannot even
> hear the proceedings and they hardly ever know who is speaking. When
> the FDA advisory panel decision is made, the media often reports it in
> incorrect terms. I\'m thinking particularly of the Tamoxifen approval
> which was approved for risk reduction, yet the media reported it as
> prevention.
>
> In addition, standards for healthy people will need to be very
> different from those who are ill. We need to know if survival is
> impacted by the drugs being studied. Cancer patients need to know. The
> system is set up to facilitate research, but that may be not enough
> for us. We need you to establish quality of life as an important
> standard. Our plan is to aid patients and if we\'re to live or if we
> die, how we feel physically, mentally and emotionally is critical.
>
> We call unwanted effects side-effects, but that doesn\'t reduce their
> importance to patients. They can be painful, sometimes long lasting,
> and should not be easily dismissed. To us, they are as central as any
> effect. Side effects are not aside.
>
> Drug approval standards are both inappropriate and tertiary. Tumor
> reduction doesn\'t often correlate with increased survival. Robert
> Templeton of FDA has said that quoted in The New York Times. Speaking
> as a cancer patient, survival is our goal. So why do we use tumor
> response as a standard? The answer is usually that we can measure
> that. That\'s not really good enough.
>
> This has resulted in those tiny incremental steps that don\'t seem to
> follow through with a survival advantage. I often think of it as
> crawling on hands and knees through a field of broken glass, and I\'d
> like to take a running leap over that field.
>
> As you begin to offer survival data to patients to patients, we will
> be demanding new standards. I know this data is available. New
> standards might include disease stabilization. Angiogenesis drugs are
> said to work by that effect.
>
> Our system obviously includes exploration of patentable drugs. If the
> answer lies in natural or non-toxic substances, patients will want to
> know that. Our tax money finances many studies in part or fully. We
> asked for human studies designed to look at total protocols as
> practiced in the real world. Many animal studies have shown the
> benefit of combining vitamin regimens for example. Indeed, we take
> antioxidants as a group, never alone. They\'ve been shown to be
> useless, possibly harmful as isolated elements. Garlic, onions, green
> tea, soy, a variety of fruits and vegetables have shown anti-cancer
> properties. I know that cancer patients would be willing to
> participate in studies.
>
> Our tax dollars would be well spent. Thank you for approving a trial
> of Tibetan herbs, even if it\'s being done in a westernized fashion
> which may limit results. In traditional Chinese medicine, Ayer-Vedic
> and Tibetan systems, each patient receives a highly personalized
> prescription consisting of many herbs. They are designed to balance
> each other, eliminating unwanted effects. Chinese have been recording
> herbal formulas for over 4,000 years. Since breast cancer is known to
> be heterogeneous, the study of Tibetan herbs may yield some valuable
> answers.
>
> At this year\'s meeting of the American Society for Cancer
> Researchers, there were again many studies on green tea. No matter. In
> the real world, no patient is going to go home to drink green tea by
> itself. We\'re going to combine it with other elements for a total
> protocol. It\'s this that we need to have studied. It must be looked
> at in a way that real patients do it in the real world. We\'re leading
> this, but you guys should be catching up.
>
> Right now many patients, myself included, are spending our money and
> our precious time on substances that may not prove useful. That\'s why
> we need your data. We need your input and we need those studies as
> soon as can be. I cannot wait another six years to see these studies
> begin. I have heard every year for the last six, well, we have no
> studies on that; well, we don\'t know anything because there are no
> studies. Well, start those studies.
>
> Clinical trials often do not gain answers to patients questions. Too
> often the aim of the trial is simply to determine of a drug can get
> approval. You ask us to participate but ignore the majority of our
> questions. An example, as a result of last October\'s approval of
> Tamoxifen for risk reduction in healthy women, there were a host of
> seminars conducted around the country. Many shared the title
> \"Estrogen, Tamoxifen, Raloxifene.\" At each forum, women raised many
> questions and all too often the answer was we don\'t know. Now
> researchers boast of thousands of women hours of data, yet we still
> don\'t know the answer to many of the basic questions about the drugs.
> This is bad.
>
> Advocacy groups are constantly asked to help recruit patients for
> clinical trials. I have just spoken of some of the barriers to that.
> Often physicians don\'t tell their patients about trials even if
> they\'re in their own centers. Or overloaded oncologists may not have
> time to consider each patient when a new trial is announced. A patient
> must learn to be an educated advocate. Well, it\'s hard to do. Many
> cannot and they shouldn\'t have to. We need to have all information on
> trials easily available.
>
> I\'ve heard it say that FDA and other responsible agencies focus on
> methods developed to fight infectious disease, especially the idea of
> the magic bullet. It\'s time for a change, a paradigm shift, to use a
> buzzword. As a non-scientist, it may be easier for me to see these
> gaps. Activists like myself watch you continue to look at the usual
> suspects in the usual way. You seek answers under the lamppost because
> that\'s where the light is. We can, therefore we do.
>
> I\'ve been told that if don\'t know how to look at something, it
> doesn\'t exist in scientific terms. That may be true from the limited
> scientific perspective, but it offers nothing for the real world, and
> as I said, cancer patients are living in the real world. New ideas,
> new methods, new discoveries have to be encouraged. No more burning at
> the stake is allowed. We shouldn\'t be dismissing new ideas outside
> the norm. People with cancer continue to die in huge numbers and we
> don\'t seem to find appropriate answers. I urge you to study natural
> and non-toxic substances as quickly as possible using a total protocol
> that will matter. Neither finances, politics or old patterns can
> interfere with our need for real world solutions for cancer. Thank
> you.
>
> DR. FRIEDMAN: Thank you.
>
> MR. BYRD: Thank you very much. Ms. Vogt.
>
> MS. VOGT: Hello. I\'m Eleanor Vogt with the National Patient Safety
> Foundation at the AMA. I\'m going to speak very briefly and very
> directly to question number four and offer a concrete suggestion.
>
> The area of greatest risk and therefore the area for greatest
> opportunity for improvement is with product use, the product and
> practice. Now as we move down the pharmaceutical safety chain from
> industry research and manufacturer to FDA approval to prescribing,
> dispensing, and ultimate end use, it appears that the availability of
> information for prescribing, compliance and monitoring falls off
> dramatically. So that the knowledge, the support and the resources
> both to manage risks and more importantly to exploit the benefits of
> the therapy in actual practice become more and more scarce the farther
> down the chain you are.
>
> This is, I think, both ironic and tragic. Now the current situation is
> that the institutions and the companies involved in the research and
> the development of a therapy product are very rich sources of
> information not only about the product but about the disease state as
> well. And a good part of that knowledge gets passed on into the FDA,
> gets added to, gets analyzed, and new knowledge is generated as a part
> of the approval process.
>
> But it\'s after this point, however, that the flow of information in
> meaningful educational resources seems to slow down. So if we\'re to
> close the gap between what we do, what we know and what we do, then we
> must move that product information and knowledge down the safety chain
> and at the same time, of course, this has to be a living process in
> which we\'re adding to this information out of our own experience and
> from other resources.
>
> And again it\'s to maximize benefit as well as to reduce risk. Now
> here\'s the key. The transformation of knowledge into practice calls
> for the overlay of a new model based on education and the
> communication sciences. This model actually evolved from the
> regulatory model which is based on law and the physical sciences.
>
> And I want to make a differentiation here between regulation as a
> function and the regulatory structural model. And I think we can and
> should have a healthy debate about the role of regulation with regard
> to communication and education products, but what I will say is that
> trying to adapt the structure and the procedures of the regulatory
> model itself do not work. It\'s not a good fit. It was never designed
> to that end. And what I\'m suggesting is that we\'re going to
> measurably improve patient\'s safety, the next step we must take is
> the creation of a practice centered or a patient centered model, which
> is grounded in science, as Jane Henney says, but it\'s grounded in the
> social sciences, in education, and communication and behavioral change
> sciences.
>
> So we need both. Here is my direct recommendation to you. The National
> Patient Safety Foundation is working very actively with the FDA right
> now in taking a systems look at the roles and accountability of all
> the players in the pharmaceutical safety chain. We\'re an appropriate
> neutral convener because we represent all the stakeholders. We have
> them at the table.
>
> What I\'m suggesting to you now is that we move on to the next step
> and we start addressing the development of this I call it a
> transformational model, a practice model, where we can start
> generating the next generation of products that will serve to close
> this gap between what we know and what we do, which everyone has
> alluded to and everyone is frustrated by.
>
> And I don\'t mean that we have to reinvent the wheel in the sense that
> there are models out there. Your own MedWatch program I think is a
> great example of bringing stakeholders together and developing and
> using the strengths of all the stakeholders. So I would recommend to
> you that you formally address the NPSF, ask, request the NPSF to serve
> as this forum to assist you and to assist all of us in developing this
> new model, again grounded in science. And this is the kind of a
> concrete action the agency can take to produce measurable improvements
> in both the safety and just as importantly the efficacy of care. Thank
> you for listening.
>
> DR. FRIEDMAN: Thank you.
>
> MR. BYRD: Thank you.
>
> MS. RUSSANO: Hi. My name is Jama Russano and I\'m the director of the
> children\'s nonprofit foundation called Children Afflicted by Toxic
> Substances. At birth, I was born with a hemangioma tumor and due to
> the removal of that tumor, I never developed fully on my right breast
> and ended up having a silicone breast implant emplaced at the age 14.
> Mind you implants were never studied nor proved safe for young women
> like myself. To this date, they still are not.
>
> I developed severe complications and I had two children that I breast
> fed that also developed severe complications. To add fuel to the fire,
> I also participated in a protocol drug study to help the esophageal
> motility disorder that I got from the implant and was part of
> Temple\'s protocol and really had adverse, again adverse side effects
> to it and was dropped from the study. To this day, I have never heard
> from the pharmaceutical company or Temple University to see if I was
> green, blue or if I was even alive.
>
> I founded CATS out of the frustration of lack of information
> concerning the safety of medical devices and other products exposed to
> children. Seven years ago I started gathering data on the health of
> children exposed to medical devices, specifically the children born to
> mothers with implants. There are close to a million children. Breast
> implants and other silicone devices, the data that I\'ve gathered
> should have been conducted by the FDA and manufacturers.
>
> I have learned a great deal about the ethics, the procedures and
> health issues across the board with the FDA, NIH, CDC, and other
> governmental agencies. First and foremost, the FDA is recognized as a
> safety net for consumers. For a safety net to be hold, the agency must
> place the consumer before the manufacturers at all times. Every time
> we the consumer sit down for a meal, take a bath, give our children a
> vitamin, we are affected by the FDA\'s work and decisions you the FDA
> holds the power to alter every person in this country\'s health and
> well being.
>
> Yet this agency is grossly underfunded, understaffed, and underpaid,
> under power, and needs more recognition by Congress. Today\'s consumer
> must be a modern sleuth. They have to become the experts in many
> cases. I have been in more instances where I\'ve been before
> physicians and I know more about silicone and poisons that affect
> children and mothers than the doctors do. They call me.
>
> We have heard it takes a village to raise a strong family and healthy
> children. I believe it takes a village to produce safe products. The
> village I see would comprise of a round table of experts from FDA,
> NIH, CDC, HHS, insurance companies that not only provide product
> liability insurance but also provide health care insurance, consumer
> advocates, physicians and manufacturers.
>
> I will address the issues of adverse reactions as the products are
> rushed to market. Insurance companies that sell liability from one
> division while paying health care claims from another division of the
> same product. If this information is combined, it would give us a
> heads up on our particular problem with the drug or device. Our health
> care providers hold significant data on adverse reactions. Yet no one
> pays attention to it or the number of occurrence.
>
> A special division with the FDA should be set up to process and
> dispense this new information. If the number of adverse reactions on a
> drug or a device is equal or greater than the number of persons in the
> study approving the drug or device, then that product should be pulled
> from the market for further evaluation. The FDA should have brochures
> in every doctor\'s office. Every prescription drug dispensed should
> have a number or an access of a web site so that they can report a
> related problem, not that the problem just goes back to the
> manufacturer where it\'s not properly reported.
>
> The FDA should charge the user a user fee from seven to ten percent
> across the board. This was mentioned this morning. Strong fines should
> be imposed when a product line has to be reviewed or taken off the
> market. The FDA should require manufacturers data on products to
> supply information pertinent to that product by complying or
> conforming the information on disk or specific data programs within
> the FDA so that it makes the FDA\'s job easier.
>
> The FDA should be able to go to Congress and ask for more funding when
> there is a large health crisis like second-hand smoke, silicone breast
> implants, just to name a few. A new department within the FDA needs to
> be formed focusing on children\'s products and products that are
> intended for children or products that children are exposed to, even
> labeling of products such a simple product like mouthwash that is not
> properly labeled, but if a child drinks it, it could cause severe harm
> to their liver.
>
> All departments would send their data for review reviewing a child\'s
> exposure before any product would be reviewed or released for sale in
> the market. My 14 year old son recently brought Wow potato chips, not
> knowing it contained olestra and seeing the big words \"Wow\" across
> the bag. He was sick for two days.
>
> Within the FDA, one department is researching adverse problems to a
> device or a chemical while the other department has approved a new
> device or a product within the same group or chemical. And that has
> proved to be a problem. A special department needs to be established
> looking at the impact of strong widely used chemicals and combinations
> of chemicals and numbers of times one is exposed to various chemicals
> such as benzene, formaldehyde, Toluene, silicone, polycyloxin that are
> used in everyday food processing and everyday consumer items that you
> shower and eat and bathe and are exposed to. Layers upon layers of
> them.
>
> The FDA should establish a new department reviewing researching
> patents. Dr. Kessler discovered vital information on tobacco and
> nicotine. I personally conducted research on 246 patents on silicone
> breast implants showing the adverse reactions and how identified
> problems were noted from manufacturers and researchers from 1963 to
> 1996.
>
> This information was turned over to the FDA two years ago but nothing
> has been done yet. All products grandfathered into the FDA or continue
> under the GRAS should be restricted until the manufacturer can prove
> their safety. New items containing these chemicals or products should
> be halted. The numbers of persons identified to those persons along
> with their social security numbers that partake in research studies
> should be constantly contacted throughout the years.
>
> The average number of persons tested in this study to approve the
> safety of a drug or device range from ten to 400. Yet, it seems it
> takes hundreds, sometimes thousands of persons harmed before a drug is
> pulled from the market. If a device or drug fails and one is harmed
> and chooses to recoup their losses through the court system, the FDA
> seems to back away from exploring the device or drug in question.
>
> As an example, silicone breast implants have never really been tested
> for safety in young women ages 13 to 21 or children who have been
> breast fed.
>
> There are no epidemiological studies conducted identifying common
> adverse reactions. Yet once the drug or the device is on the market,
> adverse reports start coming in, the manufacturers claim we need
> epidemiological studies to prove your correlation.
>
> The manufacturer then goes to a university or a group of physicians
> and drops millions of dollars to state their product is safe. They
> have hired the largest PR firms. They use the media and newscasts that
> gives misleading information. The burden of proof it seems to be on
> the consumer, thus creating a David and Goliath effect. I as a
> consumer do not have the clout nor the finances to conduct such
> studies. This is a vicious cycle and I hope the FDA places this at he
> top priority. Most physicians get their information from the
> manufacturers, not the FDA. Thank you.
>
> MR. BYRD: Thank you very much. Do we have any comments or questions
> for any of the panelists?
>
> MS. COHEN: My name is Susan Cohen. In Asia, herbs are used a great
> deal, but there\'s a social science aspect to it. They believe in the
> efficaciousness of the herbs. If FDA or anybody else does a study,
> what do you take into consideration in terms of the sociology or the
> idea that the herb is going to work because there is that factor in
> the positive reinforcement of believing what it\'s going to do?
>
> Also, Ann, you said something that interested me, and you said it to
> me before. Living in Washington, we live in a very rarified
> atmosphere. But you said that you thought a lot of people didn\'t know
> about the existence of FDA. I wish you could comment on both of those.
>
> MS. FONFA: Okay. I think, you know, it\'s certain possible that there
> is a placebo effect amongst populations used to using traditional
> Chinese medicine and herbs. However, the placebo effect is already
> factored into every study we do for everything, and as you probably
> know, it\'s as effective as almost any drug we have on the market. So,
> you know, there\'s two ways to play it.
>
> The Tibetan study that I referred to is only using seven herbal
> protocols out of a vast majority and there is 30 people in the study.
> I just hope that those 30 people qualify for those particular seven
> herbal formulas so that it\'s an accurate and effective direction.
>
> In terms of FDA, what I said and what I mean is that most of us have
> no idea how FDA operates and I\'ve been on the fringes of this for six
> years. And I still am not clear. Things that were referred to during
> the broadcast, you all know what they mean. Most of us don\'t know,
> and it\'s very hard for us. That\'s why I said, suggested we meet
> informally in ways so that we get to understand how the agency
> operates. I\'ve no idea even how many divisions there are. You know
> it\'s never clear. There is always a new thing that I discover. In
> speaking to some of the audience members, I found out about new
> departments that I didn\'t know existed. So we would welcome sort of
> either chart or discussion and many of the advocacy groups would love
> to have somebody come and explain that. That would be very helpful for
> us.
>
> MS. RUSSANO: Could I just add?
>
> MR. BYRD: Thank you. Sure.
>
> MS. RUSSANO: Most of the divisions, also within the FDA and NIH, CDC,
> they\'re all abbreviated. So people have no idea what CFAN means or
> FDAMA means so I think a good start would be to make a list of all the
> different divisions with their abbreviated names.
>
> MR. BYRD: We do have a web page and a website if that might be helpful
> to any of you. It\'s www.fda.gov. You might want to visit that
> website. But I agree with you that we have to do more in order to
> educate our stakeholders. This is the first step of many steps that we
> hope to take to begin the dialogue and begin the type of sharing of
> information that I think and Dr. Henney thinks also is very valuable
> to the FDA and to our public health mission as well. Are there any
> more comments or questions?
>
> I would like to thank the panelists. I really appreciate your
> comments. They were very thoughtful and very helpful and they will be
> recorded as part of this discussion. Thank you very much.
>
> Let me now introduce our second group of panelists: Dr. Bert Spilker,
> who is the senior vice president for Scientific and Regulatory Affairs
> at the Pharmaceutical Research and Manufacturers of America, PhRMA;
> Dana Kuhn from the Committee of Ten Thousand; Anita Ducca,
> representing the Coalition for Regulatory Reform; and Dr. Sanford
> Chodosh from Public Responsibility in Medicine and Research. Dr.
> Spilker.
>
> DR. SPILKER: Good afternoon. My name is Bert Spilker and I\'m the
> senior VP at PhRMA. I\'d like to address questions one, three and five
> from the Federal Register. On question one, the first point to make is
> that risk-based decision-making should never be undertaken except in
> comparison to benefits. Therefore, the term \"risk-based\" should be
> modified to read \"benefit-risk based decision making.\"
>
> Secondly, PhRMA supports FDA\'s desire and the need to have the most
> scientifically well qualified and competent staff possible. We support
> their efforts to recruit and retain such staff. We believe that
> setting aside some time every week or perhaps up to a half a day for
> career development activities is a high source of motivation and will
> serve to attract and retain high caliber candidates. While some
> physicians at FDA already utilize this time for clinical activities,
> non-medical scientific reviewers should also be encouraged to
> participate in projects, possibly at NIH, AHCPR or local universities.
>
> These specific activities that FDA could offer staff and potential
> candidates is a matter for FDA to consider. Medical decision-making
> has become a specialty and can be a very useful guide in making
> benefit risk decisions. Relevant FDA staff should pursue training in
> this area as well.
>
> Lastly, we encourage the FDA to have their reviewers visit industry to
> learn more about our perspectives, operations and processes of drug
> development. While this has occurred from time to time, particularly
> among the FDA chemists and statisticians, we believe that an ongoing
> permanent program should be organized for relevant professionals in
> many scientific disciplines. The length of these visits can be
> discussed with industry but we believe that short visits of one to
> five days will enable the program to provide such opportunities to a
> fairly large number of FDA staff.
>
> Benefits are substantial. And include greater understanding of each
> other\'s perspective. Other advantages include learning about current
> and future technologies, information systems, and current state of the
> art research and manufacturing equipment.
>
> On the third question which states what action do you propose for
> educating the public about the concept of balancing risks against
> benefits in public health decision-making, our answer has two parts:
> addressing messages and approaches and processes. We believe that both
> FDA and industry should educate the public as to the following
> messages: drug safety is best viewed as a balance of benefits and
> risks. The benefits of prescription medicines far outweigh their
> risks. Continued monitoring by all stakeholders in the health care
> system helps assure that an appropriate balance is maintained.
>
> There are many other specific points on benefit-risk. They\'re in the
> handout that was given. And I\'m not going to read those in the
> interest of time because that will take a substantial period, but I
> would suggest that people do look at those.
>
> The approaches that we suggest that could be used to educate the
> public might include (1) public service announcements on radio, TV and
> in print media such as magazines, newspapers; (2) the FDA could
> establish a speaker\'s bureau within the organization from both
> headquarters and district offices to present FDA\'s perspective to
> public groups, industry and others; (3) information could be and
> should be placed on the FDA\'s website; (4) information could be and
> should be sent to other government agencies such as the CDC, the
> AHCPR, NIH Health Find, and HCFA, for them to place on their websites;
> (5) there would be live or taped radio talk shows.
>
> These could even be done as a joint FDA/industry activity. (6)
> Brochures could be sent to a large mailing of federal and state
> legislators, federal and state health officials, patient associations,
> organizations, requesting publication in their newsletters and on
> their web sites including such groups as the AARP; (4) professional
> medical associations, managed care organizations, pharmacy
> associations, and others and requesting widespread dissemination. And
> lastly, publication of a series and periodic reminders in the FDA
> consumer magazine.
>
> As to question five about additional actions for enhancing
> communication processes, the FDA, the pharmaceutical industry and
> other stakeholders have had very productive, very positive procedures
> for working together over the last several years. This interaction has
> led to important benefits that directly improved public health and the
> lives of many patients through more rapid availability of drugs to
> prevent or treat diseases including improvement in existing therapies
> that make them better tolerated.
>
> Senior management within the agency has also been much more willing
> than in the past to appear in public forums such as at DIA, PhRMA
> forums, other meetings, PERI courses, and meetings such as this to
> present its positions and progress on issues. This activity should be
> encouraged and expanded to include additional constituencies such as
> medical societies, possibly in concert with industry spokespeople when
> appropriate.
>
> The current open dialogue and free exchange of views between FDA and
> industry needs to continue and there are and will always be situations
> and issues where it\'s appropriate and beneficial for industry and the
> FDA to work together for the public good. Examples of such activities
> include recent Biostatistics Workshops, the Joint Forum on
> Industry/Government Year 2000 Preparedness, PhRMA\'s Information
> Management Working Group working with FDA Information Management Board
> and the International Conference on Harmonization or ICH, to mention
> just a few.
>
> PhRMA welcomes these and other opportunities for dialogue and an
> exchange of views on regulatory policy and management. We look forward
> to continuing these and other forums where the public health is
> served. Thank you for the opportunity of addressing you today.
>
> DR. FRIEDMAN: Thank you.
>
> MR. BYRD: Thank you. Dana Kuhn.
>
> MR. KUHN: I would like to thank the FDA and Commissioner Henney for
> this opportunity to present our concerns and our issues with you all
> today. My name is Dr. Dana Kuhn, and I am a person with hemophilia,
> coinfected with HIV and HCV. It has been approximately 12 years since
> the first anti-retroviral drug for treatment of AIDS was released by
> the FDA. However, if you recall, it was only released by petition.
>
> The waiting period was approximately three weeks and I personally know
> this as I had to petition the FDA for the use of this product on
> behalf of my wife who in 1987 was diagnosed with AIDS. Unfortunately
> and to no one\'s fault, the antiretroviral did not arrive in time and
> my wife died before she could use the product.
>
> Since 1987, due to the demand from antiretrovirals and the pressure
> from many activist groups, the drug manufacturers and the FDA have
> worked quickly to fast track the needed AIDS drugs through the
> prescribed phase trials. For this, we are very grateful. However, the
> area of FDA operations which we feel has importance well beyond its
> current funding priority is post-market surveillance of adverse
> reactions to the AIDS drugs.
>
> Our community, people with hemophilia, who have contracted HIV through
> contaminated blood products, is particularly susceptible to side
> effects. Some of these are documented and some are not. A personal
> friend of mind died recently from an adverse reaction to AIDS drugs. I
> myself was sent to the emergency room for a deathly reaction to a
> newly fast track drug called systeva of which the symptoms that I
> suffered were not documented in the drug insert description of the
> side effects.
>
> We understand that the FDA loses sanctionability once a product is
> licensed and released to market, but we feel strongly that the
> American public deserves to know that the agency is staffed and in
> place to monitor newly released pharmaceuticals and biologics. We also
> realize that the pharmaceutical companies conduct post-market
> surveillance through reporting. However, we do not feel that this
> should be left up to companies alone.
>
> Suffice it to say many of us infected with HIV through blood products
> are a little skeptical of the surveillance of this type alone and some
> feel that we may not have been infected if surveillance was not left
> up to industry alone. Given the known harsh adverse reactions of some
> of the AIDS drugs, we believe post-market surveillance and medical
> studies necessary to track these effects are taken a back seat due to
> a lack of financial resources.
>
> It brings us to the point that in trying to educate Congress, we have
> helped them understand that post-market surveillance raises questions
> of FDA resources and personal power and we have met with and discussed
> with this question with Chairman Skeen of the Agricultural
> Appropriations Subcommittee of the House Appropriations Committee. We
> are also continuing to educate members of the Appropriations Committee
> in both the House and the Senate about the need to provide the FDA
> with resources to do post-market surveillance of HIV/AIDS.
>
> We supported the need for fast track of AIDS drugs and new therapies
> in the late 1980s and early 1990s. However, now with the wide range of
> choices available in the marketplace and the cocktail drugs, we
> believe a healthy and intensified focus needs to be directed toward
> post-market surveillance of the existing AIDS drugs.
>
> Obviously, this will cost money and again we are working to educate
> the relevant congressional committees about what we believe is a
> critical issue that is not getting enough attention. We propose that
> the FDA take a more active control and oversight for post-marketing
> surveillance of adverse reactions for AIDS drugs and make it public,
> make the public aware of the results of this surveillance.
>
> And I know as consumers for the Committee of Ten Thousand, we are
> going to do our part in helping the FDA try to secure that funding
> because we believe it is very important to the community who is
> suffering from HIV and AIDS. Thank you for the opportunity.
>
> DR. FRIEDMAN: Thank you.
>
> MR. BYRD: Thank you very much.
>
> MS. DUCCA: Good afternoon. My name is Anita Ducca. I\'m the director
> for Regulatory Relations for the American Red Cross. I\'m pleased to
> be here today to provide the views of the Coalition for Regulatory
> Reform, CFRR or the Coalition, on the Food and Drug Administration\'s
> meeting to talk with stakeholders about FDA modernization.
>
> CFRR was formed in 1994 at the request of FDA to bring the blood and
> plasma industries together to jointly explore ideas for a more
> efficient regulatory system for blood and plasma products. The
> coalition consists of the American Association of Blood Banks which
> includes the American Red Cross and the Armed Services Blood Program
> Office, America\'s Blood Centers and the American Blood Resources
> Association.
>
> CFRR represents virtually the entire spectrum of blood and plasma
> collection and transfusion interests. Today I will highlight the key
> points we wish to make based on the collective view of the whole
> blood, transfusion and plasma industries. CFRR supports FDA\'s desire
> to utilize state of the art science in its risk-based decision-making
> processes. Product review and approval times can have a direct impact
> on the availability of life saving products.
>
> In the blood and blood products industry, FDA has a host of new tools
> for modifications or changes to approved applications that ostensibly
> are the result of the agency\'s risk-based decision making. The annual
> report, the changes being affected and the comparability protocol are
> intended to reduce the regulatory burden associated with minor changes
> to approved applications. Similarly, full implementation of the
> biologics license application would free up scientific resources.
>
> To increase its scientific resources, FDA could enhance collaboration
> with domestic and international health organizations. Collaborative
> efforts between CBER and the United Kingdom are one example. We also
> recommend expanding interactions with domestic health organizations
> such as NIH and CDC. We also encourage further collaboration with us,
> the regulated community.
>
> There is much to be learned from each other. Interaction with the
> North American Technical Advisory Group to address the issues
> surrounding bar code labeling of blood products and the NAT
> inter-agency task force has permitted active exchange of information
> with other scientists on the cutting edge.
>
> We invite further FDA participation on such groups. CFRR also urges
> the agency to consider the need for exchange of information within the
> FDA particularly across centers and with the Office of Regulatory
> Affairs. For example, the Center for Drug Evaluation and Review
> recently approved a new drug for the treatment of psoriasis which
> included as part of its package labeling the warning that individuals
> taking the drug should not donate blood for three years after the date
> of last administration.
>
> However, CBER, and consequently the blood and blood products industry,
> were not informed about this package label warning as quickly as they
> might have been. We urge ongoing and continued consultation between
> the centers and with the regulated community to review the scientific
> information necessary to make such policy determinations.
>
> FDA has also asked about focusing its resources on areas of greatest
> risk. Some of this work has already begun. In 1998, FDA announced a
> blood action plan aimed at reinventing some regulatory aspects of the
> agency\'s approach to blood. Recently CBER has also developed a device
> action plan and a tissue action plan. These action plans represent
> important steps to begin focusing on areas of greatest risk.
>
> However, more could be done. As part of its risk-based resource
> assessment, FDA could reinvent its inspection program towards a
> systems based approach. A systems based approach will help provide
> greater focus on important safety and quality steps within the
> manufacturing sites.
>
> Self-certification licensure programs such as the proposed red blood
> cell immunization and whole blood irradiation self-certification
> programs could hold promise for appropriate allocation of agency
> resources. CFRR is ready to work with FDA to expand the scope of these
> self-certification programs to other areas.
>
> We suggest that FDA perform a comprehensive cross-cutting review of
> responsibilities of the centers along with the Office of Regulatory
> Affairs to help identify areas where the FDA resources could be
> emphasized and where they could be deemphasized. Currently, the
> manufacturer of a new piece of equipment used in the processing of a
> blood product must undergo a 510(k) review by the Center for Devices
> and Radiological Health. CBER then reviews the blood facility\'s
> license application for that device often including quality assurance
> data before the equipment can be used at the facility.
>
> Sometimes there is a prelicensure inspection prior to license
> supplement approval and during a facilities annual inspection, FDA
> local district investigators will often review the same information
> pertaining to the device and its validation. CFRR urges FDA to
> reconcile these processes with an eye towards eliminating the existing
> overlap.
>
> FDA should be acknowledged for its efforts to communicate with
> stakeholders. The internet home page is a superior resource for all
> interested stakeholders. In addition, stakeholder meetings and
> solicitations of public comment offer an opportunity to provide
> feedback to FDA on FDAMA\'s implementation. CFRR urges FDA to continue
> its current trend of announcing proposed policies via the internet and
> Federal Register notices and to hold public and stakeholder meetings.
>
> However, it is essential that such meetings be announced sufficiently
> in advance to permit adequate time to prepare. It is also essential
> for FDA to make publicly available all non-proprietary information
> provided to its advisory committees. We understand the need to be
> consistent with applicable regulations and to apply appropriate
> controls for confidential commercial information. However, this
> information, such as scientific data and algorithms discussed at the
> Blood Products Advisory Committee meetings will considerably aid our
> ability to participate.
>
> In conclusion, the coalition applauds the actions FDA has taken
> towards implementation of FDAMA and we look forward to future
> interactions. Thank you.
>
> MR. BYRD: Thank you.
>
> DR. CHODOSH: I\'m Sanford Chodosh. I am the president and one of the
> founders of a group called Public Responsibility in Medicine and
> Research, commonly called PRIMR. This is our 25th anniversary year and
> I\'m very pleased that we were invited to address this as a
> stakeholder. I have to also mention that I\'m a government employee. I
> work for the Veterans Administration and what I say does not in any
> way represent what the Veterans Administration believes.
>
> I\'ve also been a clinical researcher for well over 30 years, mostly
> in the area of pharmacology, and I have been an institutional review
> board or IRBD chairperson in the past for, oh, ten, 15 years. So that
> I come with a lot of credentials about what I want to speak about and
> that has to do mostly with number one and number two questions about
> the state of the art of science in what the FDA does and how to
> exchange and integrate scientific information. I really welcome this
> opportunity to present my ideas concerning how the FDA could influence
> the scientific aspects of the research carried out for regulatory
> purposes.
>
> I believe that a significant change should be made to serve the goals
> of the drug and device approval process while still gathering useful
> scientific knowledge. What is the current state of affairs, and this
> is mostly in bullets because I wanted to be sure I covered it in five
> minutes. Right now, by and large, industry plans and carries out
> studies sometimes by the scientific groups in the industry and
> sometimes by the marketing groups in industry. They do require often
> approval of the FDA. However, the onus is on industry to develop these
> plans.
>
> The protocols by and large reflect FDA\'s minimum standards to obtain
> approval and as far as the company is concerned for market acceptance
> purposes also. Legally\--I didn\'t realize this until
> recently\--industry only has to submit study results to the FDA. They
> do not have to under law legally supply this information to
> investigators, the institution or the human subjects.
>
> Indeed, industry rarely provides reports to investigators and often
> needs to be even coaxed to break a double-blind code after the study
> has been completed. Yes, it is true. Don\'t shake your head.
>
> Five, feedback of results to participating subjects is almost nil. In
> many areas of drug and device development, the required to demonstrate
> equivalence to a comparative drug or device is the general rule.
> Comparator agents are often selected to satisfy marketing concerns,
> not selected because they are the gold standard for the group of drugs
> being tested.
>
> The FDA allows and industry capitalizes on using investigators of
> variable scientific capability. What are the results of this state of
> affairs? Positive drugs and devices may well get approved in a faster
> way. On the other hand, the data collected to meet minimal standards
> often does not conform to good scientific methodology. Studies
> designed to demonstrate equivalence usually results in inadequate
> numbers of subjects to show anything but equivalence. And the
> selection of outcome goals and methods that are used are not as
> objective as they could or should be, and I can give you many examples
> of that.
>
> Lacking good scientific design, most of the investigation\'s resulting
> data which is very unlikely to pass muster in a good peer review
> journal. Unless a publication can be produced to help the marketing of
> the drug, the results will likely only be referred to as data on file
> and therefore not subject to any peer review beyond the FDA, but
> usable in advertising. The results of the study do not flow back to
> the investigators, the institution or the human subjects.
>
> I think this raises some important ethical issues. The subjects
> generally are led to believe that they are taking risks so that
> scientific information will be advanced. I think that in general
> we\'ve missed that our subjects. Most investigators are disinterested
> in the results because most companies are very upset when I ask for a
> report of the study. because no one else has.
>
> Why then should they be considered ethical or even legitimate
> investigators? Institutions do not insist on seeing the results of
> such industry oriented research. Shouldn\'t IRBs consider that their
> part of their responsibility is to see that the studies they approved
> were actually carried out appropriately and expect to see results.
> What can be done?
>
> Well, I think you need to change the rules. Drug studies should be
> reviewed by the industry, FDA, IRBs and investigators to ensure that
> the best science is being used to evaluate a new drug or device. Quite
> frankly, that often is cheaper than the way this goes right now.
> Because if you really design a study properly, you probably do not
> need as much work on it frankly.
>
> You need to have true scientific advisory boards. That is that are
> very specific for the topic for the drug being studied, and IRBs need
> to consider these as if they were NIH proposals. Very often, most IRBs
> will get industry sponsored studies and say, well, these aren\'t that
> important. You know let\'s look at this NIH study. That we\'re going
> to pick apart.
>
> FDA should change its acceptance of equivalence testing as the desired
> outcome. I think they should be looking to see differences if they
> exist. The methodology used should be the best objective measures of
> what is expected of the compound. Surprisingly, that doesn\'t always
> occur.
>
> It should be required that the results of these studies be made
> available to science and society. This may require some new type of
> journal or register. Currently journals should accept more
> responsibility for considering publication of negative results. It\'s
> just as important to know something doesn\'t work.
>
> However, if studies can pass peer review scrutiny, the results should
> also not be accessible for obtaining new drug approval. So it all goes
> around and around. If you plan good science and do good science,
> you\'ll probably come up with answers that are meaningful.
>
> Require industry to give results back to the investigators and the
> investigators should find means of relating the information to the
> subjects that were in the study and to their institution review
> boards. The FDA should require that industry not use their marketing
> departments to dictate publication policies and details of
> publication.
>
> In summary, the FDA needs to set a higher standard for the science
> which I think Dr. Henney obviously agrees with of the drug and device
> approval system. Industry needs to reassess their responsibility to
> develop therapies that are properly tested and reported and are
> scientifically sound. Human subjects must be provided the dignity of
> knowing what they were involved in by being given outcome results. All
> significant studies should be reported to the scientific community and
> to society whether positive or negative. I thank you very much for
> this opportunity to present.
>
> DR. FRIEDMAN: Thank you.
>
> MR. BYRD: Thank you. Are there any comments or questions from members
> in the audience?
>
> MS. RUSSANO: I have a question. First, I\'d like to applaud the
> gentleman that just\--
>
> MR. BYRD: Could you identify yourself, please, for the record?
>
> MS. RUSSANO: Jama Russano from Children Afflicted by Toxic Substances.
>
> MR. BYRD: Thank you.
>
> MS. RUSSANO: I would like to applaud the gentleman that just spoke for
> his truthfulness and his stand on this situation because I fully agree
> with it. I want to ask the woman from the Red Cross about blood bags
> and donating blood and if the Red Cross and the FDA have taken the
> position on accepting blood from people with immune deficiencies or
> severe allergic reactions like having a silicone device and then being
> allergic to silicone and what they\'re doing about it?
>
> MS. DUCCA: We have an extensive donor screening process that occurs
> before any donor can donate. It tends to focus in on questions as
> lifestyle and transmissible diseases. For the specific types of toxic
> transmissions that you\'re speaking about, I\'d have to go back and
> speak with our medical department and find out if that very specific
> level is in there currently, and if you\'ll give me your name and your
> phone number after our discussion I\'ll be sure to get that
> information back to you. But right now it is focused primarily on the
> transmitted types of diseases.
>
> MS. RUSSANO: Also, do you work with consumer groups like myself and
> other groups, maybe MS, or diabetes, to understand that you have
> searched all the questions that do need to be answered?
>
> MS. DUCCA: That\'s a very good suggestion. We do work with
> such\--well, we participate in the meetings that are held by FDA,
> primarily the Blood Products Advisory Committee, and I know, for
> example, there\'s a member of the Committee for Ten Thousand that is
> on that committee and we participate through that particular forum as
> consumer groups also participate. Again, though, for your specific
> kind of question about your particular groups, I don\'t remember them
> specifically participating in these BPAC meetings.
>
> For example, I certainly see no reason why they would be particularly
> excluded, but again that would be something that we can certainly
> explore with you and I welcome the question.
>
> MS. RUSSANO: Thank you.
>
> DR. FRIEDMAN: Thank you for your question.
>
> MR. BYRD: Thank you. Any more? I\'d like to thank this panel, too.
> Thank you very much.
>
> DR. FRIEDMAN: Thank you, all.
>
> MR. BYRD: Again, your comments and responses will be recorded. Thank
> you. Let me introduce the participants in our third panel. Michael
> Doneo from the People\'s Medical Society; Susan Cohen, a consumer
> representative; and Brian Meyer, who is from the American Society of
> Health Systems Pharmacists. Mr. Doneo.
>
> MR. DONEO: Thank you, Mr. Byrd, and thank you, members of the FDA for
> inviting my organization to be at this session today. It has certainly
> been enlightening and very informative and I\'d like to say that I
> really appreciate the comments that the other consumer members have
> made. Ann and Jama and I think Dr. Chodosh were really right on
> target.
>
> My organization is a national health care consumer information and
> education advocacy group. And we\'re generally supportive of the FDA
> modernization act. Insomuch as it does get things that are needed to
> certain populations. However, we do have some reservations about the
> expediency of perhaps bringing some items on the market, primarily
> because when there are adverse incidents, there are reactions. We are
> the ones who pay the price in more ways than one.
>
> So I don\'t think we want to see any more repeats of the Dalkon
> Shield, the Shively heart valve, the silicone breast implant\--thank
> you, Pamela Lee Anderson\--and things such as defective pace makers.
> The other thing that I think was raised here today and we are also
> concerned about it is the fact that at the present time the scientific
> stream seems to be things that the manufacturer funds and the types of
> studies and the reports and we don\'t know if these things are
> published in things that the manufacturer owns and then they\'re
> presented to the FDA as being fact.
>
> I had raised an issue earlier about tracking side effects. We\'ve
> heard Commissioner Henney mention that while we know in these studies
> there are certain side effects from medications, but I think it\'s
> also important to know what happens when you put that medication or
> that device into the general population. Are there certain population
> groups that are more vulnerable, who might have other reactions? And
> we need a mechanism for getting that information back to the FDA
> because if there is something that needs to be done, they could pull
> it back.
>
> I\'m not going to address items one and two because I don\'t
> think\--we are not a scientific group. We are strictly a consumer
> group, but I do want to address question three. And I think that
> something that\'s very important is that we need to have the FDA come
> up with a method for publicizing any fast track appliance and
> equipment or medication and by that I mean I think to have someone at
> the FDA who we can always contact, whether it\'s PIO people, or people
> from the various units. I know there was a good question raised about
> all the different divisions and subdivisions within FDA. I know when
> I\'ve called, I\'ve transferred around to get information.
>
> But I think we need something where we can always find out what is
> going on in this fast track mechanism because our concern is that we
> can get to a public, we can get to the public various ways, but if we
> know where to get good information from the FDA, it just helps get the
> message out. The dissemination can also be done through radio, TV,
> newspaper and especially the internet. And I think the FDA should be
> commended for having an excellent site. I know I use it quite often in
> the type of work that I\'m doing.
>
> And I think that one of the things that we can do is have more
> information provided on these devices\--who the manufacturer is,
> country of origin, has this product been used in some other country,
> what side effects or what adverse incidents have been reported, if
> indeed they have been? But at least give us that information.
>
> I think that information pertaining to the criteria on which the FDA
> is going to base its decision should be there. Now, this may get into
> the area of compromising some proprietary information, but I almost
> feel like Marshall Gerard in the Fugitive when he\'s looking at Dr.
> Kimball and he\'s saying I\'m innocent, and he says I don\'t care.
> Well, as a consumer group, I don\'t care if it is proprietary. If
> it\'s going to impact upon consumers, I want to know that information
> and I don\'t care if the international, multinational pharmaceutical
> industry has bought off Congress, I still want that information.
>
> And if we have to have a march on Washington to get it, I think we\'ll
> do it. The other thing I want to talk about is something that\'s
> already in existence that I think is very good, probably could be
> improved, and that is FDA MedWatch. I think it\'s an excellent way of
> getting information, but I don\'t know much of the public knows about
> it.
>
> We do a bimonthly newsletter. We also do a weekly on-line newsletter
> and we try to get things out to people. But perhaps we need to work
> together to let the general public know here is a mechanism for
> getting feedback to the people who regulate and control and can take
> action. And I think it also would help you in getting more input from
> a more varied source because of special populations using different
> appliances and medications. So I think in that sense, we\'d like to
> work with you and I think all the other groups that are represented
> here and perhaps raising the visibility of the MedWatch program.
>
> I have no comments on question four either, but I will go to question
> five. And this deals with how we can perhaps communicate much better.
> Given the fact, as was mentioned, you are in a limited resource, I
> agree, let\'s not go back and reinvent the wheel. You do have an
> excellent web site. Why don\'t we take more advantage of that perhaps
> having FDA officials available in a chat session. I know it sounds
> maybe trite at the times, but the fact is people may be encouraged to
> go on and exchange information. Maybe we could have the commissioner,
> a deputy commissioner, a unit director who is in the Devices and
> Radiological Branch who could answer certain questions.
>
> And you would also get a sense of what the public is thinking or what
> they know about these different things. And it\'s a good way to
> exchange it. I think that the FDA should also establish perhaps a
> special site within the web where we can get information on the fast
> track of what\'s going on if we want to report back and also learn
> what is currently under review.
>
> And I think there also should be an effort to, as was mentioned
> earlier, perhaps a distribution to consumer groups and other media
> about what is going on with fast track, whom to contact and how often
> reports can be made and where we can find additional information. I
> know we\'re running late so I just want to thank you for once again
> inviting me, listening to my comments and certainly inviting us to
> partake. Thank you.
>
> DR. FRIEDMAN: Thank you very much.
>
> MR. BYRD: Thank you.
>
> MS. COHEN: Good afternoon. My name is Susan Cohen and I have to thank
> the FDA for again allowing me to be on a panel as outspoken as I am,
> and I have to tell you to start off that the name stakeholder as a
> consumer really is troubling to me. I think that putting us in the
> same level as the pharmaceutical industry really does a disservice to
> consumers. I think it\'s more profound because we\'re the recipient of
> research and so I have\--and I\'ve been trying to be brilliant, to
> tell you the truth, and think up a name and I haven\'t been that
> smart. I just kind of thought of patient/consumer.
>
> But I feel that we\'re much more than a stakeholder and I am concerned
> about the future of FDA and I have a couple of things here. This is
> from an FDA publication and if I may quote: \"However, in some
> instances, products are reaching the market faster than FDA can inform
> its stakeholders.\" The agency\'s ability to disseminate information
> must be enhanced by upgrading its technology, its computers and
> training of its employees to keep abreast with the latest development
> in technology. It\'s one thing to know it, it\'s another thing to do
> it. And that scares me.
>
> And the other thing, MedWatch, which you mentioned, and this always is
> very frightening to me, med guides will be required when new
> information becomes available that raises a serious safety or efficacy
> concern about FDA approved drugs. Producing med guides will be the
> responsibility of the pharmaceutical manufacturer. Those products
> already requiring patient direct labeling must continue to provide
> such labeling. If they are such serious safety and efficacy concerns,
> why are they still on the market? And who sees these med guides?
>
> And if they\'re already on the market and there are these problems,
> why is that not also included? These are real concerns of mine. You
> know in a research laboratory, the correct protocol must be designed
> in order to succeed. Therefore, may I suggest some of the following
> ingredients for successful FDA experiment. The risk factor for
> consumers should remain the same and new technology should not change
> what is safe and effective.
>
> Consumers should not rely upon drug manufacturers through newspaper
> ads to provide consumer education because of vested interest. It
> should be one of the top priorities of the FDA to provide education
> through all aspects of the media in plain language and multiple
> languages. They should also provide information of questions you
> should be asking your physicians.
>
> People don\'t know what to ask the physicians and physicians don\'t
> have time anymore. And this is a profound problem that I think the FDA
> should take into consideration. With HMOS practicing medicine and
> physicians having to see \"x\" amount of patients in an hour, who has
> time to tell them? And you know, I was in a pharmacy day before
> yesterday getting a prescription, and there was a line of ten people,
> and I heard the one pharmacist say, tell them all to come back
> tomorrow, we don\'t have time.
>
> Well, the pharmacy industry has been encouraging consumers to talk
> with pharmacists, but if they\'re not going to be available to talk to
> consumers, it isn\'t going to do them any good. There should be a
> consumer hotline well funded that they can call directly to the FDA to
> talk about adverse drug reactions. I believe there is such a program,
> but I don\'t think it\'s well funded.
>
> The first year after drug approval should be a provisional status for
> the drugs. And severe penalties for failure to report adverse drug
> reactions should be required. The opinions of FDA reviewers should be
> highly regarded and political pressures do not make for good
> experiments. There should be no risk tradeoffs to hasten drug
> approval. I don\'t know if I mentioned that I served on an advisory
> panel or not. I have to give full disclosure. I expected other people
> to do it, and I have to tell you I own drug stocks. But I have one
> concern, the bottom line is all of us and what it\'s all about, and
> this is all about us. We are the bottom line. We are the people who
> need help.
>
> FDA should have a mandate to encourage HMOs to allow physicians to
> have enough time to discuss risk factors. I don\'t even think
> consumers know what risk factors are. If you ask the consumer what a
> risk factor is, I don\'t think they have a clue. They should know what
> a risk factor is. And about different options. In medication, we have
> direct advertising. I\'ve been talking to a lot of people because I\'m
> on another panel, and patients are coming in and asking for drugs.
> They haven\'t a clue why they\'re asking for it.
>
> But it\'s advertised in the paper and therefore they\'re asking for
> it. They haven\'t any concept of what risks are. All new technology is
> not efficacious and takes time. Therefore, reviewers need the
> appropriate amount of time to study the risk-benefit ratios. And I
> believe in continuing education for the reviewers. I have the utmost
> respect for the reviewers that work for the FDA. They work very, very,
> very hard, and I think they should be encouraged. I think they should
> be allowed to continue to learn more and more because there are new
> technologies.
>
> Many Americans don\'t have the web page and they don\'t have internet
> and they come from a different socio and economic group than other
> people. So they\'re not necessarily going to have access to all this
> information. So we have to think about those people out there that
> don\'t live like the rest of us. You know it\'s a very elitist concept
> a lot of these things, and there are people out there who need help
> who aren\'t getting. And I am very happy that clinical trials are
> going to be in different communities other than the usual ones.
>
> All off-label use of drugs consumers should be reviewed periodically.
> Has the risk factor been taken into effect for the off-label use and
> can it be monitored better?
>
> And you know one of the things that I didn\'t mention, and I have to
> thank Mary Gross because she was really very nice to me. My
> efficaciousness is much better in questions than in doing this. And if
> you look in the package, you\'ll see the questions which I think in
> the long run do the same thing, but it wasn\'t what they asked and I
> was a naughty girl and I sent in questions instead of something
> written.
>
> I think the FDA should consider going to all the wonderful consumer
> groups across the country with a well designed questionnaire and I
> think volunteers should go into the drug stores where people are
> filling prescriptions and talking to them and asking them what do they
> expect, what do they know, what are they doing there? What do they
> need to know?
>
> We\'re not getting to\--I mean there are consumer organizations and I
> know that. But we need to get to people. We need to talk to everybody
> everyday and those are the people that are filling drugs. AARP is a
> very sophisticated organization and reaches a lot of people, but I\'m
> not sure they\'re the everyday person who goes in and gets medications
> filled. I\'m concerned about the average typical consumer. I\'m a
> consumer advocate and those are the people that I\'m concerned about.
>
> Let\'s ask some questions. Let\'s talk to them. You know management
> needs to go down and ask these questions, too. And sometimes it isn\'t
> the staff that should be doing it, it should be management talking to
> people. I\'m preaching a lot, but I think the hardest thing of all,
> and I wish I knew the answer, and that\'s the risk-benefit. For those
> people who have very specific illnesses and they\'re really anxious to
> get medication. What do you do for the risk versus the benefit.
>
> Is there a way to segment this particular group of people that would
> come under a specific program where they could be part of almost a
> clinical trial to try the medication, but not make it available right
> way. I\'m thinking of the\--I sat on the panel for thalidomide and
> that\'s being highly\--as I understand\--highly regulated. We have
> to\--the general good is very hard. It\'s like traffic laws. It\'s
> not\--some people obey the law no matter what, but we have to have
> rules and regulations for everyone.
>
> But if we could realize the agony of people who need this, but on the
> other hand, we don\'t want to destroy something else. So I understand
> what you\'re doing, but I\'m really concerned because this rush to
> approve drugs is fearsome to me. And the power of industry versus the
> power of the average consumer, I don\'t think it\'s a balance. And I
> think we have to take into consideration all the aspects that go into
> it and if I preached I apologize. But I\'m profoundly concerned, and
> I\'m really frankly I\'m frightened, and I\'m a 70 year old lady and
> they\'re going to come up with a new drug for me tomorrow. How do I
> really know with that year\'s time really what the problems are going
> to be? So I wish you success and I hope all of you stay well.
>
> DR. FRIEDMAN: Thank you.
>
> MR. BYRD: Thank you.
>
> MR. MEYER: My name is Brian Meyer and I\'m the director of the
> Government Affairs Division for the American Society of Health-System
> Pharmacists and I appreciate the opportunity this afternoon. I reflect
> the perspective of our organization\'s 30,000 members who work with
> medicines on a daily basis in hospitals and other components of health
> systems.
>
> I\'d like to specifically address the third question that was raised
> by FDA in the Federal Register notice and that is what actions can be
> taken to educate the public about the risks and benefits?
>
> Everyday more and more of our members are interacting with patients in
> clinical care settings. And their experience in the case of the
> general public does not have a good idea what it means when the FDA
> says that a drug is safe, safe enough to enter the marketplace. The
> public is particularly uninformed about the risks associated with
> medication use. Drug products after they enter the marketplace leave
> the artificial situation of controlled clinical trials and they\'re
> placed in the hands of ordinary human beings\--health professionals
> who strive to maintain a thorough understanding of the product and
> patients who may not be well informed about their role in ensuring the
> best use of the product.
>
> Without fully comprehending the benefits and the risks associated with
> taking prescription medications, consumers may have unrealistic
> expectations of their medication therapy. There is a real need for
> public education in this regard and ASHP would like to assist the
> agency in developing a program to educate the public about what safe
> medication use is all about.
>
> I say assist because we recognize that both, both health professionals
> and the agency have a shared responsibility to educate the public. And
> as front-line practitioners, pharmacists along with doctors and nurses
> are safety managers, learned professionals who help patients safely
> manage the risks of their medication therapy.
>
> ASHP has been an advocate and a leader in the safe use of drug
> products. In the first precept of our leadership agenda declares the
> top professional objectives is to foster fail safe medication use in
> health systems. And among the key assumptions that we have made is the
> belief that patient risk associated with medication use will increase
> as drugs become, drug therapy and drugs become more complex. And the
> recognition that safe medication use is a growing public concern, as
> reflected by news reports and the scientific and professional
> literature.
>
> ASHP has a number of practice guidelines that our members use. I\'m
> just going to highlight a few. One is a minimum standard for
> pharmacies in hospitals and it states that patient education
> coordinated with medical nursing and other clinical staff should
> ensure that all patients are given adequate information about the
> medications that they receive.
>
> We also have a guideline on adverse drug reaction monitoring and
> reporting. And it suggests that health systems develop a comprehensive
> adverse drug reaction and monitoring and reporting program that
> includes patient involvement. And finally, we have a guideline on
> pharmacist conducted patient education and counseling, and it states
> that the pharmacies profession has the responsibility to provide
> patients with information to improve patience adherence and reduce
> medication related problems.
>
> And that has a goal to partner with patients in managing their own
> care, which is the very essence of patient practitioner collaboration
> and safety management. And that is to ensure the therapeutic
> effectiveness of their medication use.
>
> And a final guideline that we have deals with the medication errors
> and preventing them in hospitals. And it contains a section entitled
> \"Recommendations for Patients and Personal Care Givers,\" and states
> that health care providers should encourage patients to take an active
> role in their drug use by questioning and learning about their
> treatment regimens.
>
> Earlier this year in January, our organization and our research and
> education foundation brought together a group of interdisciplinary
> experts to discuss medication misadventures with the goal of
> developing a set of ideas for generating concrete action plans to
> foster this fail safe medication use in health systems. Among the
> major ideas identified by this group was one that would use patients
> and consumers as allies. Patients have the greatest interest in
> understanding drug safety.
>
> They also have a high level of trust in pharmacists. Consumer
> representation should be designed into projects formulating public
> communications such as public service announcements about the benefits
> and risks of medication therapy. Our members also have an ongoing
> commitment to safety management in their day to day practice. Every
> interaction with a patient is an opportunity for the pharmacist to
> educate the public about drug safety. We encourage FDA to take
> advantage of the pharmacist role in reducing medication roles but also
> recognize that FDA has some responsibility to educate the public.
>
> ASHP stands ready to assist FDA and other organizations and research
> projects designed about safe medication use. One area that needs
> research is the incidence and causes of medication errors in the
> outpatient and ambulatory setting, and home care setting. The error
> free prevention value of collaborative drug therapy management,
> arrangements in which pharmacists, prescribers, nurses, patients, and
> others work closely to ensure the best therapy and safety also needs
> further study.
>
> And ASHP is eager to begin a partnership between FDA, pharmacy,
> nursing, medicine and patients to conduct such research. In March of
> this year, at a policy forum on drug safety sponsored by the American
> Enterprise Institute, CDER Director, Dr. Janet Woodcock, stated that
> risk management of drugs once they\'re approved is not under FDA
> authority. But that the agency has a role in preventing medication
> errors through its regulatory requirements for product packaging,
> labeling, and distribution. ASHP believes that under packaging and
> labeling the FDA has an obligation to quickly review and revise its
> procedures to eliminate medication errors that occur due to sound
> alike names, similarities in packaging, and other labeling and
> packaging problems.
>
> As noted earlier, patients should be considered the allies of health
> care professionals in eliminating medication errors and should be
> involved in providing input into the safety design of drug product
> labeling. ASHP would also add advertising to Dr. Woodcock\'s list of
> aspects of FDA\'s role in drug safety. Specifically, we think FDA
> should be reviewing the concept of direct to consumer advertising much
> more critically.
>
> Direct to consumer advertising may induce patient demand for a product
> that is not in the patient\'s best interest. We suggest that FDA
> thoroughly research the risks and benefits of direct to consumer
> advertising and its contribution to increased reports of adverse drug
> events. We appreciate FDA\'s hesitancy in getting involved in the
> safety management of drug products on the patient level. Health system
> pharmacists, however, expect the problem of medication misadventures
> to get worse as products and more potent products enter the
> marketplace, and as these products are prescribed for more patients.
>
> But this hesitancy must not lead to a renunciation of responsibility.
> We believe that the issue of safe medication use provides us all,
> health care professionals and the agency, with an opportunity to work
> together to provide better patient care. Thank you.
>
> DR. FRIEDMAN: Thank you.
>
> MR. BYRD: Thank you. Are there any comments or questions? Please.
>
> MS. HAIRE: My name is Doris Haire, and I\'m president of the American
> Foundation for Maternal and Child Health. I have been chair of the
> National Women\'s Health Network and several other organizations of
> national prominence. First of all, I\'m very pleased that this meeting
> has been held and I must say I agree with all of the statements that
> the consumers have made at this meeting. One of the things I think is
> so terribly important for people to know, and it is such a simple
> statement, that most people do not know that only\--let\'s see\--I\'ll
> have to do this again\--that only those doses approved for specific
> conditions mentioned in the indication section of a drug\'s package
> insert are FDA approved uses of the drug.
>
> I learned that from Dick Krout many years ago. I have never heard it
> repeated in any FDA publication and it is such a simple thing for
> people to understand. So I would like to see the FDA make that a
> prominent message in the future.
>
> I\'m also concerned that when Dr. Henney was speaking today and
> talking about what needed to be done at he FDA there was not a single
> mention of the fact that the FDA has no written guidelines to evaluate
> the safety of drugs given to pregnant women. All drugs given to
> pregnant women cross the placental and enter the baby\'s brain, and
> the FDA is still using a 25 year\--it\'s over 25 years old guidelines.
> It\'s not really a guideline. It was passe when it was produced and
> it\'s even more so today.
>
> So I would like to see that the FDA take upon itself to immediately
> initiate a program to evaluate the safety of drugs given to pregnant
> women. We\'ve seen drugs can alter dendritic arborization and cause
> life long problems for the child. Thank you.
>
> MR. BYRD: Thank you very much. Are there other comments or questions?
>
> MS. FLYNN: I\'m Rosemary Flynn from the Gray Panthers and I have some
> comments. By the way, I appreciate the comments of the panel and some
> of the other panelists, believe me. But I want to comment on the fact,
> and I don\'t think I\'m mistaken, that no physicians group has been
> represented on the panels and I think\--I don\'t think it\'s an
> omission in that FDA wouldn\'t want them so I don\'t really know why
> they\'re not. But I think it\'s very important to consider the
> interaction of the pharmaceutical salesman and the physicians after
> the use of medications, after the introduction of those medications,
> and just how much information the pharmaceutical company, the salesman
> gives to that physician, and it couldn\'t be dealt with because there
> is no one here to speak to it that I know of. That\'s all.
>
> MR. BYRD: Thank you. Please.
>
> MS. COHEN: Can I make a comment and ask a question? I was in a
> physician\'s office and a detail person came in from a pharmaceutical
> company and I kind of grabbed here and I said do you have any concerns
> about the job you do? She said to tell the truth, my concerns are that
> when there\'s a new medication, we really don\'t know how efficacious
> it is or what the side effects are or the risks are, and I get a
> little concerned when I\'m so to speak bringing these free samples in
> and we have say a year\'s time and we really don\'t know what\'s going
> to happen.
>
> I just had a quick question. Is there any standards in the
> pharmaceutical industry in terms of volume in a pharmacy as to how
> many pharmacists should be there when how many prescriptions they
> fill?
>
> MR. MEYER: There is no mandated or national standard in terms of ratio
> from pharmacists and the numbers of prescriptions.
>
> MS. COHEN: Well, since we are encouraging people to ask pharmacists
> more questions, may I encourage you to consider the volume in a
> pharmacy and how many pharmacists are there. Because pharmacist
> assistants can\'t answer questions from consumers, can they, in terms
> of the drugs?
>
> MR. MEYER: Well, the most important thing is that individual
> pharmacists should take the initiative in terms of spending the proper
> amount of time with each patient. There is absolutely no question
> about it there. And we would prefer that the individual practitioners
> have the ability to make that allocation of time so that they can
> provide that to the patients as they need it. Some don\'t quite need
> as much time as others so they want to have that flexibility there.
>
> MS. COHEN: Thank you very much.
>
> MR. BYRD: Thank you.
>
> MS. RUSSANO: I\'m Jama Russano from CATS, Children Afflicted by Toxic
> Substances, and I\'m very happy to hear that the pharmaceutical\--or,
> not the pharmaceutical, that pharmacists would like to take a more
> active role, and I\'d certainly like to be a part of that, but one of
> the areas that we really seem to focus today was the drug aspect of
> all of this, where we really haven\'t focused much on health and
> beauty aids, cosmetics, which are a part of the pharmacist\'s role and
> people do inquire about that and I think that it\'s important coming
> from a cosmetic background that maybe your group might be willing to
> participate with the FDA with the cosmetic companies along with health
> and beauty aid companies.
>
> Because many people do have adverse reactions to cosmetics, shampoos
> and various things on the market. That\'s just one suggestion. The
> other thing is again in pertaining to children and what is happening,
> I think that the FDA needs to really focus on the amount of chemicals
> that these young children are absorbing in their bodies from this
> processed food.
>
> You know there was an article in the Houston Chronicle this Monday
> about the amount of chemicals that our children are exposed to and how
> it changes their immune system and changes their mental chemistry,
> making them more violent, making them more aggressive, and that issue
> after we\'ve seen what has happened cannot be ignored.
>
> And I went to my inlaws 60th anniversary this weekend and a 100th
> birthday last week, and they never been to MacDonald\'s once or a fast
> food restaurant. I think that has a lot to say about something. But it
> is important and even though drugs and devices are top of the list
> here, I agree. We still need to look at that and there needs to be
> more consumer groups working with the FDA on these issues.
>
> MR. BYRD: Thank you.
>
> MR. DONEO: One other point I\'d like to make very quickly and I think
> it was the fact that consumers need more information and my group
> recognized this. About 12 years ago, we put together a publication
> entitled \"How to Choose a Pharmacist\" because we recognized early on
> that when you look at the health care delivery team, it\'s not just
> the physician health practitioner, but it\'s also the patient and the
> pharmacist very often because you\'re getting a prescription, and we
> have given a lot of suggestions on questions to ask about the
> different medications that are being prescribed, not just the
> medication itself, but also any side effects, any interactions with
> other medications you may be taking, whether they are prescription,
> OTCs, vitamens and minerals, because this is all information that you
> can convey to your practitioner as well as the pharmacist to help give
> you some guidance.
>
> Another thing, I was glad to hear you mention is the fact of tracking
> and reducing hospital errors. We did a seminal publication several
> years back entitled \"Medicine on Trial\" where we examined what was
> written in professional publications about medication errors, about
> surgical procedures gone awry and what have you. We work with a
> pharmacist in our area who heads up an institute known as the
> Institute for Safe Medication Practices and he and his partner are
> both hospital pharmacists that have done great strides in trying to
> reduce. You probably know Michael Cohen who was excellent.
>
> He will work with hospital pharmacies to try to reduce areas where
> accidents and mistakes can occur and he also works with manufacturers
> in trying to change the labeling and packaging so that when something
> is prescribed it\'s pulled from the shelf, that you\'re not going to
> get a drug that is only injectable or should be mixed accidentally
> given to someone. But they came up with a formula that in an average
> size hospital, you could have up to 300 medication errors per day,
> which is what we told consumers early on. When that pill comes in, ask
> who ordered it, what are the hours, what\'s the shape, what\'s the
> size, the color, whatever you need to do, make sure you know you\'re
> getting the right medication. So we have to work together on this. I
> don\'t think it\'s just any one. It\'s a team effort.
>
> MR. BYRD: Thank you very much.
>
> MR. MEYER: I guess maybe slightly to respond if I may and maybe to
> conclude and it is striking a balance between both the patients and
> the health care practitioners and regulatory agencies to get a good
> understanding of risk and benefit to achieve the best outcome here.
>
> MR. BYRD: Thank you. I\'d like to thank this panel. I really
> appreciate your very thoughtful comments. I\'d like to thank all of
> the panelists again. We appreciate all the comments. They were all
> recorded. A lot of the comments suggested the need for the agency to
> do a number of new things and to do a number of things better. And it
> also recognized the agency\'s need for additional resources. We
> particularly appreciate those who recognize that need. We hope that
> people in the audience and others who are part of our panel will
> continue to support the agency and particularly the agency\'s budget
> request.
>
> I would be remiss if I didn\'t make that comment. We also, before we
> conclude, Ms. Sharon Holston, who is the Deputy Commissioner for
> International and Constituent Relations, will provide closing comments
> and a wrap-up for today\'s stakeholders meeting.
>
> MS. SMITH HOLSTON: I should say I was going to provide closing
> comments until Mr. Byrd just provided closing comments and a wrap up.
> So this isn\'t going to take me long at all. I think, first of all, I
> also would like to express the appreciation of the agency for those
> who have come to be with us this afternoon and who have been
> supporters of FDA for a long time and many of you are individuals with
> whom I\'ve had the pleasure of working many times in the past, and I
> appreciate the fact that you continue to come out and support us and
> to give us the benefit of your opinion.
>
> One of the things we heard today is that I think our stakeholders
> really do want FDA to make decisions based upon the best available
> science, but they also want us when we have information available to
> us, to find better ways of communicating that information to those
> individuals, organizations that are affected by it. I heard that from
> consumers. I heard that from the industry. Everyone wants to have as
> much information at their disposal as possible and they\'re looking to
> FDA to figure out mechanisms for sharing that information.
>
> I think there are concerns. I heard concerns expressed about the fact
> that we are approving drugs at a fairly rapid pace, and although I
> think most people out there who need the drugs, want them available to
> them as soon as possible, there\'s still concerns about the agency\'s
> ability to do adequate post-market surveillance of drugs, particularly
> with the limitations that we have on our resources.
>
> There is concern that we do more education about the benefits and
> risks of drugs. That consumers need to understand that there are
> tradeoffs and that some of the decision making about whether to use a
> drug or not to use a drug, for instance, is dependent upon a consumer
> making informed choices about their own benefit-risk equation and we
> need to help by providing them with sufficient information to make
> that decision.
>
> I think everyone is interested and supportive of two-way communication
> process, between FDA and a particular stakeholder group as well as
> between FDA and among stakeholders. There\'s an interest in having
> stakeholders work together with FDA, and finally just to repeat again
> what Mr. Byrd has said, there is some recognition of the fact that FDA
> has limited resources and that there are many organizations and
> individuals who want to help us become adequately resourced to do the
> tremendous job that we have to do.
>
> Again, we want to thank you for spending the time with us this
> afternoon. We will be having stakeholder meetings again in the future,
> not only because of FDAMA, which mandates that we do this kind of
> activity, but because for those of you who know the agency, you know
> for many, many years, it has been a part of the way we do business
> that we do reach out to consumers and to other groups to try to get
> their input into the agency. So we look forward to our next
> opportunity to hear from you and thank you again for being with us.
>
> \[Whereupon, at 5:04 p.m., the meeting was adjourned.\]