Good morning. I am lori mcginley. I am a help than science reporter here at the washington post. I am delighted to be joined this morning by acting fda commissioner, dr. Ned sharpless. Thank you for being with us. Good morning. Thank for having a. Dr. Sharpless has been on the job a little over two months of the fda. Was previously the director of the National Cancer institute. Dr. Sharpless, let me start by asking, you been there a whole two months now. So, how do you hope to make your mark on the fda . I think maybe it is relevant to talk about my background that brought me to my job a little bit. I a cancer doctor. At some point, transition from taking my patients more in the lab from running in Academic Research lab cancer. I felt like we were, at that time, the progress of cancer was really slow and it was frustrating. From doing the same things over and over with patience. We were helping them. To the degree that i would have liked. Beyond became a researcher. And at some point during that, i also got into the Wonderful World of administration by becoming a cancer directorate north carolina. From there, the white house called me about nci in 2017. Cancer institute is a great place. That was a terrific job back at a wonderful place to work. s great scientists of this wonderful sense of passion. And, that, and then, you know, as you mentioned recently, two months ago, back to the fda. That background i think, informs my thinking about what the fda can do. I am pretty familiar with the discovery and development works. Think that that is an area where outpatients, we have to do streamlining efficiently. I think, and see i was passionate about how we use data. I felt like there was a lot of data that could be better aggregated and used in a more effective way. I think that conversation directly translates to the fda. I think, something i really focused on at the nci was developing a workforce. Make sure we have the right talents to address the future needs for a cancer research. And that, that problem directly translates to the fda, where, staffing the right people for these, regulate is very Innovative New products that we have, is a real challenge to the fda. So, the stuff that i do at nci that the sort of similar to what i would like to do at the fda. There are some things that are fda specific federal different. The fda has a role across beyond cancer. It has food and cosmetics and animal products. It has tobacco control. A number of areas where some of those, those approaches, developing a workforce using data, modernizing Clinical Trials. I know a lot from the cancer world i think are applicable. But there are also areas where are quite different. Do you expect your agenda to be different from . Or would be pretty much the same . I think, i am a big fan of dr. Gottliebs. We agree on a number of things. Think he was in many ways, identify the places for the agency to go that i strongly agree with. And plan to continue. But the facts on the ground change. And there are areas where things have to be done, you have to change your thinking, and change, do mild course corrections. So there will be some of that. Are you satisfied with Clinical Trials at this point . You have been an advocate of making them quicker, cheaper, more accessible to people. What more can the fda do on that . Something from discovery. I dont know its generally appreciated, the spiraling cost of trials. Per patient cost. Thats a real challenge for discovery. That makes it more expensive and slower, and therefore, drugs , new therapies will become available to patients in a way that we would like. And, so, i think, the nci was very committed to trying to use novel approaches, which may include, the days of two large randomized trial showing overall survival advantage are no longer appropriate and cancer for most patients. There is some of those. There is a need for that kind of trilingual situations. But, i think we should be very comfortable using other endpoints another trial designs. And using data from the real world for what happens to patients when they get out and get cured in the real world. Think the fda has been very aggressive about adopting a particular cancer. But another disease types as well. , i think it is going to have to happen. Because, as the approaches become more and more precision based, the groups of patients become smaller and smaller. Doing large randomized trials. Because its more difficult. The poor, a novel Clinical Trial design is going to be important. For both the research effort, like the nh, and also, at the fda. At the cancer research, what are you most excited about . There are advances on the horizon. Averages they you thought we are getting a little blasi about them. There are so many and last for years. Theres a speech i get. For example, we just had to ask you to clinical psychology. To chicago talk about cancer. This, if you read the coverage of, this year, it gives you the sense that it was a. Haskell. There was no big wow. Moment. And i have been in the field long enough. I remember when going to asko, there was one year the big story was that we had four different regimens for lung cancer, not officially work. They were all equally ineffective. But one was less toxic than the other three. They found a less deadly way to not treat your cancer very effectively. Now, you go to asko, this down asko had a survival trial in breast cancer, lung cancer. A new product that was exciting. Drug, therapy for k rask. Target we have been working on for 30 years. Its exciting actually. If you look at the fda perspective, the therapeutic areas. Theres a lot going on. Cancer, and perhaps gene therapy and gene therapy. Its a bright spot. Im surprised we dont antibiotic development. There are areas where we have a real therapeutic need, where the project, progress does not seem as bright me. Im asking stuff like why does cancer seem to work better in terms of novelty discovery than other areas. This is something we can do from a regulatory perspective to make that, disseminated that acrostic to classes . Whats the answer to that . I think part of the success of cancer has been a good biologic understanding of the problem. When i was on the council of National Institute of aging, that dni has a large portfolio of alzheimers research. I was always, you know, arguing that a lot of the funding should really be spent on the basic signs of alzheimers. I didnt feel like we had a sufficient understanding of that disease to do these large conical trials. Think history has proven that therapeutic basic understanding there needs to be approved. So i think, part of it is a sort of nih basic science. We have got to find the right questions and develop a better understanding. I dont think that is solely the issue. I think, you know, the use of certain points to improve drugs and cancer has been a good thing in many ways. Has allowed us to get drugs approved. The cycle times for cancel drugs used to be the longest. Very, very long. And it was daunting to a Pharmaceutical Company that decompressing cycle times using accelerated approval another fda approaches. Has been really beneficial for cancer. Even the approaches pretty much tissue for hiv, it has been useful for cancer. I wonder, do we have a kind of endpoint that has been used for approval and other dicta classes so they can shorten the cycle times and get a path to approval that would be incentivized companies to work on them. We know youre not responsible for drug pricing. But, i am just wondering, what you think about the high drug lysis of the cancer drugs, the new cancer drugs and gene therapies. Are you concerned about how society will handle it, and whether people with lousy insurance will not be able to get access to the drugs. I am concerned that a number of ways. Someone you used to take care of a lot of patience, i know people have had to make the choice between their dictate medicine after their bone Marrow Transplant or the rent. I know, nobody should be forced to make these kind of choices. The high cost of drugs from the Patient Point is very concerning but i also worry about the burden. Its not the fda problem, but from up here perspective, from the cms i, the burden of these very expensive therapies on American Healthcare cost. Its very concerning tech i think it is also important to say that drugs are expensive for multiple reasons. How we should feel about those groups is probably a little different. Sometimes a very expensive. Therapies are very expensive because they are really innovative, highly novel, new inventions. First demand kind of stuff. And that bothers me when those therapies are extremely overpriced. It does not bother me as much, because my senses there. Somebody did something really great and thats good for humanity. And having a drug that works that is expensive is a better problem than having no drug at all. What we see in many therapeutical aspects. But, the other reason, another reason drugs can be high is because they are so alike, shenanigans. Base pay for their and patent gaming are the sort of regulatory sort of virtual monopolies that can get created. Those are areas the fda frankly has more to do. So, we can try to create a different pathway that prevents those things from happening. Its wonky but very important things decca like having having a purple book for. 180 day exclusivity period in the sorts of things allowed engineers drug to come to market. And that area i think the fda can support these market based pro competition approaches that can lead to approvals. I think, you know, there been more success, the drugs. Thats an area where the fda micro approvals in the last few years. Support from congress. That side of the house is in better shape. Announcer 2 engineering is developing. Its still early days, but for over 20 now. Approved. That number is going to grow. And we Just Announced guidelines whereby bio similars can be by a subjective guidelines which will make them better from a perspective of driving costs down. Diptych abilities and things there, too. To make biologics and small molecule drugs available in sort of generic. Dr. Gottlieb was a big critic of youth vaping. Well no. Im just wondering, the fda has taken some steps on the. But, if under age vaping continues to go out, as it very well might. And the data shows in the next survey, which i think, probably will be available this summer. That the register going up. Look at the fda do . What are you prepared to do on that . I think its important to say, i dont really need to wait to see another set of bad numbers the summer to know that this is a problem. I think the fda is already all in on the topic of Youth Tobacco use and youth and vaping. This is, this has been an epidemic, an explosion of youth use. And is of great concern. I think perhaps in retrospect, the Enforcement Discretion period the fda initially tried a fiveyear period, was too long. Think we all agree that is the case in epic in fairness to the fda, when they made that decision, e cigarettes were not the product they are today. They sort of look like more of a niche thing appealing to you now, thats no longer true. There has been this explosion of youth use and vaping has changed. So, the fda is already and will continue to do number of important things. We had enforcement. We have inspected 1 million retailers. We sent out thousands of warning letters. We have a communal, we have this practice with under age people like Tobacco Products and identify the frequency of to the stores. Some chump change that can be 3040 of stores will sell to you that appropriately. We have huge education campaign. We are trying to get into high schools and middle schools with an antivaping message. We have cracked down on the social media influencers. These people who are online, that are basically hocking nicotine or nicotine containing products in a way that is, that literally violates fda advertising rules and not disclosing the products of nicotine. They are sort of hyping these. And they are coming in, appealing looking young adults with tattoos and muscles and millions of instagram followers. And the kind of thing that would be appealing to a 15yearold kid. So, we are trying to, you, enforcement and education, leslie, policy right. I mentioned enforcement you think is too long. We are now accelerating that. Do you anticipate further acceleration . Epic i do because you are probably aware, been decisions and the academy of pediatrics and others. Enforcement discretion period. Working with the judge and the plaintiffs to try and come up with a remedy that is a lot faster than what it was, because i said, nobody in the fda anymore really things that the 2022 was a good idea. Yet, still something the fda can actually do. There is perhaps, we dont know how many of these applications we are going to get. Could be a very large number. And each of those requires a review process that is fair and valid and we have to make sure that we have the staffing capabilities to do that. But, that is not an excuse. That is justified. We have to make sure we can do this in a way that is, that really protects American Public health. On regular cigarettes, what is the single biggest thing that the fda can do about that to reduce smoking . I dont think theres a single thing. Were, we would have done it. Hes an oncologist, as an oncologist, i just really find combustible cigarettes, traditional cigarettes, to be about one of the most dangerous products in america mike. 600,000 deaths per year in the United States related to tobacco. 30 of cancer deaths are probably still tobacco associated. By the way, those numbers are improving. So, cigarette use has been declining. So, down to 600,000 deaths per year. I think that is striking about how the problem is pernicious and hard to deal with. 3050 million smokers in the United States. Of combustible cigarettes. Thing, the things that we have been doing in terms of education and other policies to try to discourages have been affected. The question remains, what other forms of nicotine replacement therapy beyond just, lozenges, like electronic nicotine with those really help smokers quit . And, there are some data from the uk that that is true. I think the United States is obligated to think about the use of those kinds of devices for Tobacco Cessation in adult smokers. But, its a really tough Public Health help to depict on the one hand we dont want to encourage people to use common nicotine addicts who are reticular the kids. But if there is an offramp, if you will, when you quit smoking, its better. Want to make sure buttocks are available to smokers. What about the effort to reduce nicotine and cigarettes. Dr. Gottlieb also talk about banning nicotine cigarettes. What does that sound . We have a couple of those rules dictate flavored cigars, nicotine levels and mental band, all of those advancement approach in aggregate, probably over 100,000 comments. Thousands of comments parole. Already to those looking at the science, and it is one thing to say you want to set a level of nicotine. But the details of that would matter. And how much would that be . The last thing you want to do is set a number that wasnt right and encourage people, you know, if you reduce nicotine levels modestly, for example, you might just make people smoke my. So, you have to think about a threshold that really would get people to quit. As opposed to merely encouraging use. There are scientific questions related to these policies. There are technical challenges. But i am confident we are going to figure these things out and get some continuum of these policies. We are out of time but i have to ask you one more question, which is, do you expect to be nominated to be the permanent commissioner of the fda . Expect. I think i would like to be nominated to be the permanent commissioner. I read about the acronyms. I figured out dictate federal government. A wonderful, marvelous place. Announcer 2 i think, you know, it would be a great place to be involved with. The decision of who runs the fda is really up to the white house. I have always said, im a federal servant and i will do it you need me to do. That is the acting for a while. Did. Find confirm commissioner, that. I will say, the fda needs a strong voice in charge of it. It has a number of, there are a number of sort of problems the fda has to face with the media, with government, with hiring, and retention, and so preferred physician in many ways would be good for the fda. Take a long period of acting would not be good for the agency. We really are out of time. Thank you so much, dr. Sharpless. We really appreciate you being with us today. , my colleague, paige cunningham, will be here with her guest for the next segment. Thank you. Thank you. Many Childhood Cancers have not seen new therapies in decades. My budget will ask congress for 500 million over the next 10 years to find this critical, lifesaving research. Good morning. I am Paige Winfield cunningham. Health policy report and author of youre at the post. And i am excited to introduce my guest this morning. Senator jack reed, democrat from rhode island. He has been a huge advocate for pediatric cancer. He recently cover the Childhood Cancer survival ship act research act which was signed by law by President Trump lester. Unfortunately, senator o couldnt join us. I was cancel. We are happy to have senator rita this morning. Im cited about the conversation. But i want to ask a different question. We have got some breaking news about patrick shanahan. Trumps defense nominees confirmation. His hearing has been delayed again. Reporting today. Due to allegations that his private life. What can you tell us . We are still waiting for a nomination from the president. That is all we havent received it yet. So, we cannot begin formal deliberations. And i, when we get the nomination, will have to start doing our Due Diligence as members of the Armed Service committees, dr. Nominee. And then, schedule a hearing. Right now, we are beginning our deliberations on National Defense authorization act. That should take up two weeks. So, the schedule is already full. So, anything that would happen would probably be weeks from now. Even if the nomination came up within the next few days. What are some of the questions you have about these allegations . First of all, we have to look at the reports. You cant just begin to speculate. You have to look at what the evidence has been presented. The fbi is doing an investigation. They always do an investigation with highlevel appointments. And then when you look at that, the questions involved, you move directly from that reporting. The administration announced 1000 troops are going to support efforts in the middle east yesterday. But was nowhere to be found. He is in charge of this appointment. He is the acting secretary defense. He has full authority as the acting secretary defense. To conduct at the direction of the president , these operations. Did dictate for the responsibility would go to the central command, general mackenzie, who is the central commander. I presume as requested, these troops as a defensive measure and deterrence measure, from what im hearing, they are designed to protect our forces and provide defensive capabilities in the region. But it would be under general mackenzie that these troops would operate. Do you think the president said withdraw his nomination . He hasnt made a nomination yet. So, that is not only hypothetical question. We are waiting for a nomination. I guess, do you think they should reconsider it. Again, he has not been under the nomination yet. So, it is difficult to reconsider a nomination you have not made. His issue is really, nominate mr. Shanahan. If he does nominate mr. Shanahan, the senate will do a job. But do you think shanahan is the best candidate for the job . I think there has to be an evaluation that is done on the record. What he has done has the acting secretary. What he did previously as the undersecretary. Any other role of secretary of defense. The government deserves consideration, if your nominated. The question right now is, with the president nominate him . The conversation about pediatric cancer research. The resident has called on congress to allocate 500 million toward pediatric cancer over the next 10 years. But, his Budget Proposal also would have slashed overall funding for nih and the National Cancer institute. Is the president sending message here. I think absolutely inconsistent. The operation of the National Cancer institute mia agent general. Is not as discrete as one might think. There is a collaboration between scientists. There is basically research that can open up venues that help pediatric cancer. Just focusing on pediatric cancer and then cutting most everything else, i think would be so disruptive, that it will not advance pediatric cancer. May be inhibited. The research. What do you think about the funding level that the president asked for for pediatric cancer. Dina Speaker Pelosi had criticized that asks saying it wasnt nearly large enough. That the frequent criticism you will hear from democrats when the republicans propose spending. How much money do you think congress should be devoted to this. . We have in our legislation has 30 million per year. Put that down. I think we should increase that. And i think we should do it in the context of not cutting other places in nih, but an increase in funding in nih and the National Cancer institute in particular. Because, this is something that we need to do to find a cure is defined the diagnostic kit techniques, better treatment techniques. , this is an effort that should be, not just restricted to one part of nih, but the whole enterprise. I believe that, if you look at overall nih funding, only about 4 , sorry, bunny for the National Cancer institute, only far beyond those of pediatric cancer. I dont think that is, of course, a small percentage of total cancers diagnosed. However, it is the second leading cause of death forgets after accidents. So, why havent we seen more funding for this . I think part of this was, before we started getting reactive, that began in 2008, with the passage of carolyn pryce walker legislation, which i was i believe was sponsored in the senate. That was first time, we are going to commit money specifically to pediatric cancer. 30 million. Start getting the states to create registries, so they can track cancers. Then we are going to do much more in terms of education and outreach. And then we built on that the star act. Which was started in 2018. So that we have been trying to increase the focus. I think one of the problems you alluded to in your question is, the good news, is that the number of cases of Childhood Cancer in the country is about 1112,000 per year. Not excusable, but the family of a child with cancer. But it is not the same level of other types of cancer. They tend to get more attention, more resources, because of the sheer number. That is why we felt we had to in 2008, to really focus on pediatric cancer. To get that as a focal point, because it was being overlooked. Yeah. I know a lot of your bill has to do with improving opportunities for scientists and research pediatric cancer. What were the shortcomings . The registration tries to address fire banks and state registries. How does that work . This is an evolution. The two pieces of legislation. When we created the registries in 2000 eight legislation. What we want to do is basically, you know, get the statistics of the instances of cancer, the types of cancer. Get it nationwide. So the scientists can start looking at trends. Give them clues as to how to focus their research. And then, in the later legislation, the star act, we also started looking at the effects after a child has recovered from cancer. Because we had indications that the other medical complications as they got older. We wanted those complications to be charted. Collected, so that they would no. And medical professionals would no. That if a child is going through a certain cancer therapy, they might be more susceptible in this type of later noncancer medical incident. To start doing that. The other thing we started trying to do, is to get the nih to start collecting vile samples and a consistent way throughout the country, so that the researchers would not have just a small group studying one particular obstacle, but to call on a much broader range of data, and therefore, makes the Research Much more Effective Work and, we hope it will lead to cures. A lot of this, i must confess, began as many of these issues did by first depreciation. Think this was a common appreciation of childhood disease. Cancer or otherwise. It has an effect, not just on the individual child, but the whole family. Most families cancer, otherwise, it is not just that that child, it is the siblings. It is the mother picket is the father. That is one of the reasons i thought this was very important. Than i had the opportunity in 2004, a couple came in. Vince and nancy hade. They had just lost their son, ben, to cancer. They had one other son, nick pickett just a wonderful family. And vince was a master chief in the navy and the submarine service