tv Politics and Public Policy Today CSPAN November 30, 2015 9:00am-10:01am EST
and caffeine is six cups of coffee. this is my third one, so i think i have three to go. sugar, however, no. jurisdiction by regulating laboratory developed test and e-cigarettes and cigars for the first time. i want to make sure that the fda's use of resources, to make sure the agency stays focused on accomplishing its core objectives as directed by congress. that's just a comment. you don't have to respond. food safety modernization act. i wear two hats here. i am chairman of the committee and a member of this committee. i'm concerned about potential overlap with the new regulations and the requirements that farmers and ranchers with which they already have to comply. we need to make sure the fda is working with the department of
agriculture to ensure these new reg and requirements are being harmonized with those on the books. would you work with us on that if confirmed? >> yes. >> i want to follow up on senator isakson's concise arguments with regard to draft guidance. i'm apprehensive of the use of the guidances as they lack transparency and can escape the cost/benefit analysis and other scrutiny. what are your thoughts about setting a maximum period with which they can be stangsubstant revised. shouldn't the agency be required to publicly respond to the concerns or at least how the concern has been addressed when a guidance is finalized or if the agency rejected the concern? >> senator roberts, i am a big advocate of transparency. i so appreciate what you're bringing up.
it's been noticeable to me, the issues that you raise. it's also noticeable, as i mentioned earlier, that every time we give people an opportunity to interact with the fda, they seem to want to do it more. in our user fee situations, for example. the number of meetings requested always greatly exceeds the number we have. the critical thing to me is getting whatever the correct format is moved along as quickly as we can through the process so that pple understand what the fda is really thinking. and in the case where it really needs to be a rule, they understand the rule and how to implement it. to get the details, i need to spend more time with you to completely understand how you see it but would be glad to do so. >> i appreciate that. my final question. where is duke ranked right now with regards to the basketball situation? >> i'm glad you didn't ask about football.
i think duke is somewhere around number four or number five. >> i think they're number five. would you be interested in knowing who is number four? >> i think that might be that school in the midwest that we often beat up on when it comes to tournament time. >> it is the university of kansas. i just want to point that out. i might add that south carolina is number one. but we'll take care of that. and i'm sure -- >> you mean north carolina is number one. >> yes. that's correct. >> unc. i would rather have kansas number one, actually, than unc. but that's a different story. >> i have no further questions, mr. chairman. >> thank you, senator roberts, for your illuminating inquiry there. senator baldwin. >> thank you, mr. chairman. ranking member. so, pleased so have you here today. and was pleased to have an opportunity to meet with you prior to this. we all agree that it's critical
for the products that are approved by the fda to be of the highest safety and efficacy standards. and that the public must also have meaningful access to accurate information about treatment so that they can make the best health care decisions. i share some of my colleagues' concerns with the ever-increasing drug prices. there has been a little bit of dialogue about that already. and i think that we can do more and should do more to improve drug accessibility, affordability and transparency. so i want to start with transparency. dr. califf, the public still lacks comprehensive access to information about medical products. for example, companies do not consistently report clinical trial outcomes for drugs in the
public databases, as a number of recent studies have noted. and generics are not yet able to initiate a change in their patient labeling if they learn of new safety information because the fda has not yet finalized the generic labeling rule. so, in your new role, should you receive, when you receive confirmation, how would you improve access to accurate information on drugs for patients, for doctors, for researchers, and how would you ensure that the fda maintains patient safeties once these medicines actually reach patients? >> i'll try to be as quick as i can with this because that's a very important question that you're asking. first, i'll point out again that every study that i was involved in has been published. i think that's a mandate. when you ask someone to
participate in a human experiment, the informed consent says you're doing it to create generalizable knowledge. we have an obligation. even if we don't like the study, the result was lousy, we need to publish it. i was a co-author of a new england journal paper pointing out the reporting. one interesting side issue is that industry is doing better than n.i.h. funded investigators. we have work to do there. i am pleased to say working with the n.i.h. they now have a policy you won't get your next grant unless you put your result in clinical trials.gov. the third element, the surveillance system we talked about sentinel. this is needed. we're dealing with generic drugs that have been on the market for up to 40 years and we're still learning about them. we can't have a system where it
depends on the innovator company to figure this all out and somehow make it public. we have an approach -- we just had a meeting two weeks ago with other federal agencies and there is general agreement that we need to have a national evaluation system which is publicly -- really a public good. the companies can develop the best products. that's fine, but we need to work towards this. >> i want to switch gear, given the role of the fda in food labeling. you and i had a chance to speak with one of wisconsin's products. we're the number one grower of cranberries. and i know that a couple of other members of the health committee represents states that have a robust cranberry also. i'm concerned about fda proposals to update food labels, specifically with added sugar information, may cause confusion
for customers and others by categorizing cranberry products, which are clearly highly nutrient-dense fruits that need added sugar for palitability, as somehow comparable to foods that they shouldn't necessarily be compared with. for example, should you be comparing cranberry juice to other fruit juices or to soda pop. should you be comparing dried cranberries, crazens, to raisins or candy. as commissioner, how would you ensure that these and other fda food policies appropriately account for the unique health benefits of food like cranberries and ensure that consumers are going to have the type of information, comprehensive and accurate, that will allow them to make healthy and nutritious decisions? >> i appreciate that.
i have noticed cranberry juice has frequently been in our refrigerator at home. it may have to do with some health benefits attributed to t. it's an example of the balancing act the fda has to do. we have an epidemic of diabetes and obesity. we have to preserve nutritious foods that need a little sugar to make it better. i talked with senator warren and with you a little bit about the fact that we need to work on the cognitive psychology of labeling so that, when we do take actions and put information out there, it's interpretable and helps people to make good decisions. ultimately it's up to people to make their own decisions, but if we don't present it in a way that's clear to them, it could lead to the wrong decision. >> thank you, senator baldwin. the next senators are senator cassidy, franken, kirk and bennet. senator cassidy.
>> enjoyed the meeting. thank you for coming by. several questions. first, we've -- going back to the drug pricing. clearly we've seen companies like touring and valent abuse the social contract which gives you a reasonable rate of return for drug marketing and they've gone way beyond reasonable. now, i have been told in the case of touring that an approval of a generic would take several years because clinical trials will be required to prove that the generic competitor was the equivalent to that which touring now has as a sole-source provider. now, this is a -- you know, we know this is a 60-year-old drug. it comes to mind because i'm reading now in premise on a compounding component would make the same drug available -- of course, compounding, a doc has to write the prescription. in a sense, compounding is doing
what generic can't do. so i guess my question is, if we know that the -- i presume we know that the compounded drug being sold for a dollar a pill, as opposed to $750 from touring, take that as an advertisement for anybody who wants a reasonably cost drug. if it is a dollar, why can't we do this in the compounding space but not in the generic space? why does it take so long to work this through the generic? you see what i'm saying in this is cognitive dissonance. >> i know you are a doc and you have an understanding of all of this. but let me point out, as i mentioned earlier, every drug is a little bit different. and the whole goal with generics, in most cases, is not to have to do major clinical trials. it's really just showing that you actually have something that's equivalent, and i believe you spent a lot of time with dr.
woodcock on this recently. there is a lot we can tell about the molecular structure in pharmaco dynamic studies. so when it comes to compounding, we're working hard on the standards for compounding because we had some disasters with compounding that have required -- >> the disaster is more related to infection control. fungi entering as injectable. this is obviously an oral drug. and i presume -- i mean, knowing that there is liability involved and premise would not be selling it were it not bio-equivalent. >> i'll have to get back with you on that because i don't know the details on that particular drug. i would be glad to do that. >> just because i see how that these folks have established the business model works. i have something from valiant, the fellow paying $566 a prescription. it's now $5500 a prescription. total exploitation of the system that has been a pretty good social contract and how is breaking down because of these
folks' frankly greed. if we're going to somehow circumvent that, we have to come up with a more efficient way to do the generics. looking, it's so clearly is working with compounding, that it seems almost like it should work as well with generic. >> again, i would have to get back with you on the specifics. i did have a pharmacy compounding operation that -- at duke hospital that was required for some of our intensive care unit medicines, and i'm aware of the complexity of compounding. it's not as simple as it may sound. i would have to look at the specifics of this and get back with you. >> that's fair. secondly, which is related, going to the chinese -- the drugs which are manufactured in india and china. i gather that the fda recently sent out a warning that said investigators went, looked, observed holes in the walls and
roof which allowed pigeons access near production equipment in multiple manufacturing areas. there is evidence or at least suspicion that somebody was hiding audit trails, et cetera. so on the -- i'll just say, again, cognitive dissonance, on the one hand we're continuing to allow folks to import even when good manufacturing procedures are obviously not being followed, and yet it seems like we're putting roadblocks up for those producing domestically who could give us some relief from the exploit ative practices. i don't expect you to comment beyond making the observation. >> i understand what you're saying. i had the privilege to do a lot of work in india and china over the last decade. it will be a focus we have to pay attention to. a large part of our food and drugs and device supplies come from india and china. we certainly don't want to
disadvantage americans in that regard either. >> if we found those gmp were not being followed, would we shut down those components of the supply chain? >> we can't shut down something in india or china, but we can shut down importation. >> the ability for that to be used -- >> and we do that. >> i fieyield back. >> thank you, senator cassidy. senator franken. >> thank you, mr. chairman. i note that you and senator baldwin and now senator cassidy have all talked about what we're hearing when we go back to our states, about pharmaceutical costs. i think that's something we really have to deal with. and the exploitation of positions that companies have gotten. dr. califf, i want to talk about probably the basic question that you face, which is the delicate
balance that the fda plays in -- in making sure that products get to people who need them quickly but at the same time making sure that they're safe, that is, that's what you deal with every day. and i have tried to promote this balance in legislation that i have introduced with senator burr, the fda device accountability act of 2015. given your experience as an outside adviser and now as an internal leader at fda, how -- how can fda use the tools at its disposal to strike this balance? >> well, when it comes to costs, we do have some tools we can use to help out. the first we've already discussed, which is doing everything we can to do a good job with a generic drug situation.
we're at 88% now. and that's a good thing. but we now also have biologics, which -- bio-similars are now coming up. we have over 50 applications in the works. and we're going to need to do a good job with that too because that's a big expense, and we want to make sure that people have access when it's appropriate and safe and effective. so the criteria are stringent there. one other that is very important to me, which people wouldn't normally think about that much but i think it's going to come up more and more is that, if we really fix our evident generation system, that is stream line clinical trials, get the data that we need, people wouldn't spend money on expensive drugs when they're not needed. we need to have better information for people, and several senators have brought that up today. i think we can do that in a fairly dramatic way. and then finally, we do keep
track of shortages. we prevented over 100 shortages a year in each of the last four years. one year i think it was up over 200. there is a constant surveillance that goes on. people have to notify us when there will be a shortage problem. the new area we need to work on is when someone gets a monopoly. understanding who the competitors are and making sure that they're doing the right things to be able to compete and get their products on the market. those are the things that we've gone through that we can clearly do fully within the fda. >> okay. quickly i want to turn to a different issue, which is making sure that products continue to be safe once they've hit the market. once they've been approved for the market. this is -- you've mentioned post-market surveillance. does the fda have adequate authorities here to do -- that you need to do -- to do this
adequately, or do you need additional ones from congress? >> i would have to -- i would have to get back to you on the specifics of what you might be thinking. the thing we clearly need is a better system for post-marketing. sentinel on the drug side is revolutionary and fantastic. on the device side we're doing better and better but we have a plan that i hope we can really enact because i believe, when we find a problem for the most part we can deal with it, but we've got to have good data, and quickly, in order to identify the problems. >> i want to talk about generic drug labeling and generic drug labeling rule. this has to do with the rule-making that you are doing on generic drug manufacturers and requiring them to update
their warning labels and provide new safety information. this came out of the supreme court decision. what is the current plan for finalizing the fda's generic drug labeling rule? >> thank you for asking. that's a very important issue, as i have said. we need to make sure that, if there are problems with generic drugs that come up later, and they do, with better surveillance systems, that there is a way of making sure the labels are update and consistent across similar products. so, as you know, we got a lot of comments on the proposed rule that are under consideration. i can't talk about decision-making. we're in the middle of it. but it's a very high priority to get this finished. >> okay. thank you. thank you, mr. chairman. >> thank you, senator franken. the next senators are senator hatch, senator bennet. senator scott, if he returns.
and then senator sanders. senator hatch. >> thank you, mr. chairman. i'm very pleased to be able to support your nomination. i'm very impressed with what you've been able to do, not only with your life but all the work that you've done down there at duke and elsewhere, to be honest with you, you deserve a lot of credit and you think you'll add a great deal to the fda. let me just say this. i am very concerned about data exclusivity. as you know, when we did hatch-waxman, we made sure there was enough data exclusivity time so that they could recoup the monies, the costs. the average cost, according to what i've been told for a pharmaceutical drug is about a billion dollars and up to 15 years or more because of the pace at fda. for a biological drug, about the same. average cost $2 billion.
to come up with a biological therapy that is approved by fda. i'm very concerned about it because, if we reduce that data ex cluesivity time, especially with regard to bio, you're talking a lot more, and you're talking about our industries subsidizing other countries all over the world. and paying really so they can have these therapies, bio-therapyinies really at our expense. at the same time, in order to recoup the amount of money it costs to go through fda, the cost of these therapies is continually rising. i'm considering -- i just want to know if you feel that we can move ahead quicker on these matters and make it so that these companies have a chance to
recoup their monies that they've invested. >> senator hatch, i do understand your concern that we want to make sure that, if someone invests in the development of a drug there is a return on investment. otherwise, people won't invest in our kind of society. >> you also understand that, to -- the more it costs, the more difficult -- difficult it is to recoup the funds, and the longer length it takes to recoup them as well, without, you know, charging even more than we do now. >> as you know, the fda doesn't set the length of data exclusivity. >> i know. >> what we can do are, that you bring up, is the cost of development is largely driven these days now by the cost of clinical trials. we think we can do trials that are actually bigger and include more patients and are more representative for a much lower cost. so i hope you work with us on that. >> i'm going to work with you on
it, but it's an important issue, and it even becomes a major issue with regard to our trade promotion authority bill and also the transpacific partnership. if we don't allow enough data exclusivity time we're not going to develop these therapies, especially in bio. bio is one of four or five techniques where we can actually find treatments and cures. if we find the cures, that over time will save us trillions of dollars. so i am very concerned about this system working very well. >> i've been fortunate to be a leader in the development of several biological therapies that have made a difference, so i appreciate what you're saying. >> yeah. also, hatch-waxman has made a real difference as far as getting -- i remember when we did hatch-waxman it was like 18 years to get a -- you know, a
generic through. today it's -- and it was very, very difficult. now it's kind of automatic because -- >> we're doing better. 88% of prescriptions are generic, so it's been a tremendous success. >> one issue that significantly affects many entities in my home state is the fda's october 2014 proposed guidance on the regulation of ldts, laboratory developed tests. as you know there has been a robust conversation on this proposed guidance between stakeholders, members of congress and the fda ever since the announcement. does the fda intend to issue final guidance, or does the agency plan to allow for further comments and feedback on the next steps proposed? >> well, as you may know, this is an ecosystem issue where we want to have universities continue to innovate but we also want to ensure patients that they're getting accurate test
results for analytical and clinical validity. so we're collecting a lot of information, ongoing feedback. we just had two days at the fda of all the stakeholders talking about next-generation sequencing, so we're still collecting feedback. we want to find something that stimulates innovation but also assures patients. >> mr. chairman, may i ask just one other question that would not -- just requires a yes or no answer. >> sure. >> thank you. do you believe, as prior commissioners have, every one have told me this -- that the dietary health and education act provides authority to protect consumers from unsafe products? >> we're fully aware of our authorities. you'll see a lot of action where the authorities are pertinent in the near future. >> do you agree you have enough authority? >> we're very well aware of our authorities and plan to use them
as congress has directed. >> all right. thank you. >> thank you, senator hatch. senator bennet. >> thank you, mr. chairman. thank you, dr. califf, for your willingness to serve. we're delighted that you're here today. in my view the fda has been extremely successful implementing the break-through therapy pathway, which has led to the approval of 32 life-saving drugs and over a hundred more in the pipeline. when i was first working on this bill with senator hatch and senator burr, colorado start-ups were saying to me that all of the venture capital in this country was moving to asia and europe because of the regulatory uncertainty at the fda. and i think all of us want to keep jobs here, and we want to give patients safe and effective drugs as soon as possible. it looks to me like this breakthrough pathway may be achieving both. i wonder whether you could talk about it a little bit. what have we learned about regulation, and can this kind of approach be modeled in other places at the fda, including at the device center?
>> thanks for your comment. my two sons from colorado are listening carefully, i am sure, to your thoughts on this. but breakthrough -- >> barbara mikulski is not here so i'll say we'll gladly move the fda to colorado if that would make the family closer together. >> the concept of breakthrough is where things look promising early on, it's going to make a dramatic difference and there is an unmet need for a life-threatening condition. the fda works closely with the industry to move things along as quickly as possible. there have been a whole series of cancer issues in particular that have just delighted the cancer community and people who otherwise would die. my mom back here has multiple myeloma. she is now on her third or fourth chemotherapy treatment. and it's been a tremendous success to have the community working with the fda and with industry and with academia in a concerted effort. that we don't need this for
chronic common problems where there is already effective treatment. we want to make sure we don't rush things to the market that aren't safe. so the real key is having the criteria to identify where this kind of activity is needed. >> well, i want to say that, at least from my perspective, is it fashionable to criticize the agencies, this is a place where i think the fda has really gotten it right. how about on the medical device side of the equation? >> as you know, there have been issues with medical devices moving to other parts of the world. but they're beginning to come back, and one of the reasons is the early device research program that's been developed by crh together with the community. that is working with the big centers that can do the early device work, bringing those things back. there's also an issue with devices that you i think know a lot about, which is often a device is useful in a very unusual disease and it's a very niche activity where there is not an adequate market.
and we do have a program for that. it's successful. it's a topic that we need to think about and success more to define ongoing criteria. >> i should also say that the cancer community was vitally important in getting that piece of legislation passed to begin with. it's nice to see that some of the early drugs have been drugs that fight cancer. i wonder if you could -- switching gears -- wonder whether you would take a few minutes to discuss with the committee how we should think about investment in life science innovation, not just as a domestic priority but as a global economic priority to keep us competitive with other nations. this is a time, as you know, when we're seeing diminishing resources in this country applied to basic science. i wonder if you could help us understand why that's important or whether it is. >> well, i think it's a case that almost everyone is concerned about, living longer and being more functional in
their lives. the way we do that is through public health and also through medical products. and in the case of tobacco, reducing it, hopefully. and as we go about that, the development of new medical products does require investment, because it's appropriate that there is a law that says you have to show you're safe and effective before you come on the market. and this requires time to do the development. and it requires that you really show that you're not producing an inferior product before you come on the market. it's really a critical issue. so we've got to invest. on this note, in our work with the n.i.h. we're focused on the use of biomarkers, surrogate end points and also not using them inappropriately when they're not going to work. this is hard work to set the conditions that would excite investors to put money into biomedical science. ultimately the united states is saving the world through investment in the n.i.h.
i want to put in a plug for continuing with the n.i.h. investment. if not for the science funded through the n.i.h. we wouldn't have the basic science to translate into medical products. >> thank you four your testimony. >> i want to thank senator mikulski who left the hearing. senator casey for allowing senator sanders to go next. he has been waiting patiently and has ex tra curric lar activities he is attending to. >> thank you. you and i chatted a while back. and i told you that i would not support your nomination because i believed you are not strong enough on the most important issue that the american people are concerned about with regard to prescription drugs. and that is, as you know, in our country we pay, by far, the highest prices in the world for prescription drugs. as i understand it, about one out of five americans cannot afford to fill the prescription that they are doctors are
writing for them. mr. chairman, with your permission, i would put into the record a comparison of drug prices in the united states and canada which show that on major and important drugs the prices in canada are far, far less expensive than they are in the united states. and that's true all over the world. my concern, mr. chairman, is that, while last year the top four drug companies in this country, pfizer, johnson and johnson. novartis and hoffman roach, maid $57 billion in profit in one year. i heard concern that drug companies are not doing well. they're doing quite well. yet you have millions of americans who cannot afford the high cost of prescription drugs. so while all of us agree that clearly we want great new products out on the market to save lives, for millions of people it doesn't matter what the products are. they just cannot afford them. we need, in my view, an fda
commissioner who will be aggressive and understands that very simple principle. and i am not clear and what i heard today confirms that i don't think you get that. do you think -- hear are some of the questions i would like to ask and make out the point. i think it is not a coincidence that last year the pharmaceutical industry spent $250 million on lobbying and campaign contributions and employed some 1400 lobbyists. do you think, dr. califf. that that type of expenditure has any time of impact on the fact that we pay by far the highest prices in the world for prescription drugs. >> senator sanders, the ideal situation would be in the money went into r&d to see if an adequate picture went to treatments. >> why do we pay the highest prices in the world for prescription drugs? >> i am not an expert on the price of drugs, senator sanders but i'm sensitive to the fact that in the field like cardiovas
cl lar -- >> it doesn't matter what the drugs are because their patients can't afford them. let me ask you this simple question. as head of the fda, you will oversee the importation of food products, vegetables, fish from all over the world. we can import lettuce and tomato vegetables from farms all over the world, but somehow we cannot reimport from canada brand-name prescription drugs manufactured by the largest drug companies of the world. can you explain to me and do you support the re-importation of bran brand-name prescription drugs from canada and other major industrialized countries? yes? no? >> you're aware from our previous discussions we have concerns about reimportation. the system it would take to make sure the drugs are -- >> you think we can bring in fish products and vegetables from farms all over the world
but we cannot bring from across the canadian border brand-name drugs? you don't think we have the capability of doing that? >> we have the capability. it would add additional cost and systems would have to be put in place. >> this is why precisely the american people are paying by far the highest prices in the world for prescription drugs. it's beyond my comprehension that you're saying we can bring in vegetables and fish from all over the world but we cannot bring in brand-name drugs manufactured by the largest pharmaceutical companies in the world from a country like canada. i just do not accept that. let me ask you another question. the reason -- one of the reasons we pay the highest prices in the world is today, as you know, i could walk into a drug store and they could tell me the medicine i use, the price has doubled because we have no regulations. do you believe that and will you support the right of medicare to negotiate drug prices, which is now currently not allowed by
law? should medicare sit down and negotiate drug prices to lower the price of medicine? >> you're aware that is the straes's position in certain circumstances that negotiation on medicare prices should be done. it's not the fda's ring mat to set the prices as we've discussed. >> the issue i affordability is within your jurisdiction. let me conclude, mr. chairman, and let me thank, again, senator casey for jumping over him here, that we all want great medicine to come onto the market. and i respect the work that you have done. but at the end of the day people are dying, people are not buying the food they need because they have to pay outrageous prices for medicine because we have been extraordinarily weak in taking on the pharmaceutical industry that is ripping off the american people. i believe that we need a commissioner -- and i know that's not the only responsibility of the fda, but i believe we need a commissioner who is going to stand up to the
pharmaceutical industry and protect the american consumers. and i'm going to have to say to you, with regret, that i think you are not that person. thank you very much. >> thank you senator sanders. senator mikulski also stepped aside as well as senator casey. senator mikulski, thank you for being here. >> dr. califf, welcome. senator sanders has just broached very briefly the issue of fish. he says we can bring in fish from around the world. i want to suggest to you that perhaps bringing in fish from all around when it is mislabeled, misnamed, is not something that we want to do. and i would ask you again to look at the issue that we have raised repeatedly before the fda regarding the pollic nomenclature. as you know there is something where we contend that you do have the regulatory authority to
change the exceptable market name from alaska polak to polak so that we can put some limitation and parameters on what we're seeing from the large volume of russian harvested polak sold to u.s. consumers as alaska polak. i have repeatedly raised this and would ask that you would work to expedite this change and remove the blockade that has been created within the fda's bureaucracy regarding this polak nomenclature. >> senator mikulski, i have enjoyed my visit with you and heard clearly what you said then. as you know, we are still open for comments and thinking about this. so i will work with you to come to resolution on this issue. >> well, i do want to work with you. again, i think that this is something that can easily be resolved and that's what we're
looking to do here is to address it through the regulatory rout as opposed to the legislative, which we will do if we have to. but i think that this is one that we can fix working together. the last question that i have for you also relates to seafood. this is regarding some concerns that we're hearing that the -- that the forthcoming fda seafood advice to pregnant women on seafood consumption may not be entirely based on science. this is something, of course, that is gravely concerning. back in 2014 there were -- there was a statement that was released on the draft seafood advice that spells out pretty clearly, science now tells us that limiting or avoiding fish during pregnancy and early childhood can mean missing out on important nutrients that can have a positive impact on growth and development as well as your
general health. now, the concern is, is that the fda has revised that advice in a way that ignores this net effects report. so the question to you this morning is, what is the status of the fda seafood advice for pregnant women, and i guess what i would like to hear from you specifically is, is whether or not, when that advice is released, whether that final seafood advice for pregnant women and nursing mothers will be based in science, namely, using the net effects report. >> i can assure you it will be based in science. and i think the recommendation will be something that will be very good for american people. >> why would it not be based on the net effects report? >> well, you know, we are having to balance a lot of input and
considerations here. >> and with net input and consideration be based on the ience that went into that report? >> well, it will be based on all the scientific facts that can be brought to bear that accumulate over time. so these will all be considered. i think you'll be happy with the recommendation when it comes out. >> well, i -- i appreciate that assurance. it doesn't necessarily get me to where i would like to be, which is a recognition that you would -- you will utilize that net effects report, the report that very clearly outlines why it is important for the nutritional needs of not only the mother but developing children as well. >> i mean, i'm very familiar with the concept, but the detail i'll have to come back to you on to make sure that -- >> can you tell me when we might
anticipate this report, then? >> well, as you know, i can't give exact dates or time lines, but this is -- this is a fairly straightforward issue, and it's a high priority. and we've had discussions about it recently. so it's going to move along. >> i would agree that it is high priority. it is important, and it is overdue. and certainly the science is overwhelming in its support for -- for the recommendations, good, sound recommendations based in science that pregnant and nursing women be given good advice when it comes to seafood in their diets. thank you, mr. chairman. >> thank you senator mikulski, and thank you for your courtesy of senator sanders even though you were chairing a hearing and thanks also to senator casey. dr. califf, after i call on senator casey, i'm going to leave for another appointment and turn over the hearing to
senator scott, who will ask his questions and then, if there are no other senators, who will conclude the hearing. but thank you for being here. senator casey, thank you for your courtesy to senator sanders. >> mr. chairman, thank you. thanks for the hearing. d doctor, we're grateful you're here. we appreciate your commitment to public service and that of your family. that i know and we all know that, when an individual makes a commitment to service, that it involves a sacrifice and a contribution in a substantial way by your family. so we're grateful for that. i want to try to cover maybe three topics, one or two of which i might have to do by way of written questions. the first is children, and that's where i'll spend most of my time. the second is food safety. and the third is the issue that's been raised about independence and ensuring that's the case going forward. first, with regard to kids, we're told that today is world prematurity day. so we're talking about premature babies born, i guess, one in ten born in the united states today
is born prematurely. we had legislation over time, obviously, that speaks to this. one is the recent fda safety and improvement act which required among other things that fda hire a neonatologist in the office of pediatric therapeutics to work on implementation of the provisions of the act for neonates. that happened. that hiring was done. we are grateful that that happened. one of the areas i will be looking at more broadly as you do your work is to focus on the implementation of changes by the fda that come as a result of both the best pharmaceuticals for children act and the pediatric research and equity act. we can amplify those later. but just with regard to treating premature infants, we know that more must be done to accelerate
the development of both therapies and devices to treat infants in so-called nicus, neonatal intensive care units. if confirmed, my first question would be how might you use fda's existing authority, the regulatory authority, to promote the development of cutting-edge treatments for premature babies? >> thanks for asking that question, senator casey. you may not be aware of this, but when the best -- when the children's act first came into existence i was one of the instigators with the phrase children should not be therapeutic orphans. that is, doctors were forced to give treatments to children with no evidence about the right way to give the treatment. we ended up at duke being the coordinating center for the n.i.h. part of this to take drugs off patent and figure out the rate dose. now we have a neonatal intensive care network from my old institute which is focused on
this. i have written about 20 papers on the topic. we need to move along and move on to pregnancy which is another high-priority issue where the right dosages of drugs are knot kno not known, for the most part. >> the second question might take more reflection because it's kind of a broad-based question. you can certainly amplify or add to what you say here by way of a written response. but anything you can say about -- or anything you would hope that congress would do to increase fda authority in this area? >> the food safety? >> i'm sorry. on -- >> on children? >> yes. >> i think we're in pretty good shape where we are in terms of authority. but if you have good ideas, let me know. i think the studies could be better and cob broade-- could b but i think we could make it happen working with the
community. >> i will move to one other question as it relates to children. so-called neonatal abstinence syndrome. we're told now, among other statistics, that one baby is born every 25 minutes with opioid withdrawals, meaning the equivalent of neonatal abstinence syndrome. it's increased some five-fold in the last 12 or so years. the majority leader, senator mcconnell and i got a bill through senate and i guess yesterday the house that we hope will be signed into law to focus on this problem. anything you can tell us about your previous work or work you can do leading the fda on this specific issue as it relates to neonates? >> this is a terrible problem, the concept that an unborn child would be exposed to opiates and essentially addicted at birth. as you know, we had a public meeting on this recently.
like the opioid problem altogether, this is a community effort we've all got to work on, including the fda. we have a whole series of measures are implementing including physician education which is critical. tens of thousands of docs have now taken the required courses through the rems program. i look forward to working with you on this. we have a lot of work to do on it. >> thank you very much. could i have one more minute? >> yes. >> i know you're waiting. on food safety, one of my constituents just recently was severely sickened by -- withl s listeria in 2012. i guess as a result of ingesting ricotta cheese from italy, among
other stories i know that constituents have with regard to food safety. i know this is a resource issue. or i should say lack of resource issue as well. can you tell us a little bit about what you able to do even within the confines of limited resources? >> well, it's been a real privilege getting to know mike taylor who heads up fisma and this part of the fda. he's been doing this for years. a dream of his was to get fisma put together. we're now moving to the implementation phase. and i think the real key, because this is such a massive -- food is just, you know, a lot of things. high-quality analytics like every other industry is using now really is what we're implementing so we can target the inspections to where the highest risk is. we're even using genomics from bacteria to figure out exactly where they come from from doing complete genotyping like we do with people. so it's really moving the science along. as you know, realigning the
workforce so that it's allocated to preempt and prevent these problems before they occur rather than just reacting. >> and i'll submit for the record a question about the issue was raised about independence, and i appreciate what you said in your testimony about the duke contract as well as your own steps you've taken since being at the fda on recusal. i'll develop a broader question to send to you. >> i appreciate it. and i'm glad to respond. i just wanted to note in light of senator warren's questions, duke university has graciously agreed to make the contracts available. and i think they're either in the staff's hands or on the way. so it will be good for you to look at those. and also just to note that the consulting money abided by these principles but i also made a personal decision to donate to money to not-for-profit charities. it's just really a sign that the work is something important, not the money in this case. >> thanks, doctor. thank you, mr. chairman, for the
extra time. >> thank you, senator casey. dr. califf, thank you for your willingness to serve and allowing me to clear up the fact that you're a south carolinian. >> it's great to be here with a fellow south carolinian. >> thank you, sir. especially since senator byrd is now gone, so we'll continue. dr. califf, i co-founder of the sickle cell caucus. we focus attention on making sure that people appreciate and understand the devastating impact that sickle cell has throughout the nation and specifically within the african-american communities. as you know, sickle cell is devastating to communities and families. it is also one of the most expensive diseases to treat given the high incidence of hospital readmission. and yet we haven't had any new treatments introduced in the market, some say for 20 or 0 ye -- 30 years. how can we create an environment in research and development for diseases that affect smaller segments of the population? >> thank you for asking that
question. one of the regrets that i have about the wonderful opportunity at the fda -- i mean, i was glad to do it, but i left behind some things i was working on, and one of those is the issue of diseases that affect minority, particularly poor minority people differentially. we had a big project going on in north carolina, west virginia and mississippi looking at the population base using electronic health records. and one thing that pops right out at you is sickle cell disease, while people are children, pretty well covered by the medicaid system. >> yes. >> with first-rate care. then when people become adults, they're on their own, frequently live in rural places. they can't get to the big centers. and this has created a disincentive to therapeutic development. the good news is nhlvi with gary givens, the head, is a good friend. i was working with him and i think there's a comprehensive plan including some of the designations for moving therapeutics through more
quickly. i'm aware of some of the new things that are in development, and they look really good. if i wasn't here, i'd be working with those new things. >> excellent. thank you. two diseases that affect my state at a rate higher than the national average are heart disease and diabetes. in 2013, heart disease was the leading cause of death in south carolina and accounted for $3.1 billion in hospitalization costs. in 2013 as well, 11.3% of south carolinians had diabetes. we are in desperate need for cures for these two chronic conditions. however, the high risk and cost of trials, particularly phase 3 trials, actually seems to create an incentive for researchers and investors to avoid working on medications that could help the many americans and south carolinians suffering with these chronic diseases. what ideas do you have for
reforming the clinical trial process to incentivize researchers and investors to delve into the high-risk but high-reward areas of medicine? >> i'm tempted to ask how many hours you have, but i'll keep this brief. first of all, let me just make a note that in the population base studies we were doing with the cmmi innovation grant in north carolina -- unfortunately not south carolina, west virginia, mississippi, it's really devastating. this was focused on diabetes. we need to get it under control. in addition to the cures that you mentioned, we also they'd to just deliver good health care to people close to where they live. and that was what our project was doing, using electric tropg health records to sis up systems in neighborhoods so people got the care that they needed to deal with chronic disease. but on the clinical trials front, it's a problem that's related to something we discussed earlier. which is that for a disease like heart disease where we have a lot of effective treatments already, we don't want to let something on the market that's not going to be safe and effective.
so we have to do adequate clinical trials. but here's the good news. we're committed, as are all the federal agencies, to work with industry and academia to develop a system that develops larger clinical results with larger prop la population and at a lower cost. the key is using electronic health records that we already have. almost every american has one. we've got to overcome the interoperabilities. that would develop therapies at a much lower cost but with better information about safety and efficacy. >> back in september i had an opportunity to ask dr. woodcock of the fda about labeling of vial similars. she stated there were trade yots in various decisions but did not provide clarity as to what industry, physicians and patients can expect and when they can expect it, which was a primary part of my question was the when.
i continue to feel as if there's a serious risk in not providing notice that a product is similar considering that there can be small differences between bio similars and their branded counterparts, unlike with generics. can you provide any update on where things stand with the labeling of bio similars? >> what i can say, senator scott, is that we're working really hard on it, and it is a very tough, complicated issue. as i've already said, much of my career in cardiology was developing biological products that were highly effective. these molecules are complicated and difficult to work with. you really have to understand them. dr. woodcock is actually one of the world's authorities. so i have a lot of confidence in the approaches that she's taking. the labels ultimately have to both encourage the use of bio similars where they're as good and enable providers and patients to understand when there are differences. and we're really working hard to come up with -- and also have to
fit in with global standards about nomenclature that exist so that as these are on the market, they can be tracked. so if there's a safety problem, we can keep up with it. those are all the factors. as you know, i can't tell you exactly when we'll be done, but everybody's interested in this, and it's a very high priority. >> thank you for your time today. the hearing record will remain open for statements for ten days. i ask that senators submit any written questions by 5:00 p.m. on november the 24th. thank you for being here today. the next health committee hearing will be on mental health on wednesday, december the 2nd. the committee will stand adjourned. >> thank you.
coming up, a conference on bringing new prescription drugs to market. and live coverage this afternoon, the head of the international energy agency talks about the long-term energy outlook. >> abigail fillmore was the first first lady to work outside the home. teaching in a private school, she successfully lobbied congress for funds to create the first white house library. mamie eisenhower's hairstyle and love of pink created fashion sensations. mamie pink was marketed as a color and stores sold clip-on bangs to women eager to replicate her style. jacqueline kennedy was responsible for the creation of the white house historical association. and nancy reagan as a young actress saw her name mistakenly on the blacklist of suspected communist sympathizers in the late 1940s. she appealed to screen actors guild head ronald reagan for help. she later became his wife. these stories and more are u