[inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] lets continue our second panel, and we thank our panelists for being here and for sitting through the first panel. Before i introduce our panelists, let me to say a few words. I think sometimes it is important to take a 30,000foot look at the systems under which we live. And we dont do that often enough. We deal with crisis by crisis. In my view, we are living with the Healthcare System which is broken and which is dysfunctional. We spend twice as much per capita on health care than any other country on earth. 13,000 every year, which is unsustainable. And yet despite that, 85 million americans are uninsured or underinsured. We are seeing in many parts of this country, unbelievably, above and beyond covid a decline in our life expectancy. We have half a million americanv whoever your experience bankruptcy which is related to the medical debt that they have. And we saw during the pandemic how unprepared we were for the major healthcare crisis that hit us. There are a lotot of reasons for the dysfunctionality of our Healthcare System, but one of them to me is the outrageously high cost of Prescription Drugs in this country, and what that means is that one out of four patients who received a prescription from their doctor are unablee to afford to fill te prescription. How absurd and counterproductive is that . Aukus to me cases these folks arerd only going to sector. Maybe they end up in the emergency room at a higher cost to the a system. We see medicare costs are extraordinarily high because they pay very high prices for the Prescription Drugs that they dispense,an meaning our deficit and National Debt go hyper at that altogether we are losing about 60,000 people youre unnecessarily because they cant afford the medicine they need or get to a doctor on time. So the questions that weve got to ask ourselves is, is our current Prescription Drug model working . Well, i guess it is working for the pharmaceutical industry and the pbms. Because they make tens and tens of billions of dollars a year. Their ceos make compensation packages of millions of dollars a year. Andd yet, millions of peoplenn cannot afford the outrageously high prices that we pay. Ask is how does it happen thatto we paid by far the highest prices of any major country for Prescription Drugs . Ive been with americans going to canada where they got their medicine they needed at onetenth the price of paint and the United States. All right . So what hope we will discuss is the dysfunctionality in my view of the current model and how we advance to another model which starts what we all want to do. L do we all believe that it is terribly important that with cutting edge Prescription Drugs to save lives . Yes, we do. Do we all understand the best drug in the world is meaningless if somebody cant afford it . Do we all understand we have a huge deficit which is in some ways attributable to the high cost of healthcare and Prescription Drugs in this country . What are the tools we need . What should we be doing that other countries do . St where they provide Prescription Drug to. The people at a fractin of the cost that we pay. Those are some the issues that hope we will be discussing. Senator cassidy. Thank you, chair. I have been so efficient i put away my opening remarks. [laughing] lets wing it. Thank you all. You all bring a unique perspective to this issue. We emerged from the pandemic with an understanding that however robust poppel was in the past those not adequately robust for the pandemic through which we just went. The always save the generals fight the last war. I think our generals plan for the next. It is true the generals are helping to plan for the next war. Somethings will we be considering here that are traditionally alone far afield from pahpa but thats where the committee has been picked nonetheless i look forward to your input and you all but awake very impressive resumes. Let me thank you all for giving a time to be here. Erthank you. Okay. Thank you, senator cassidy. Our first witness s will be docr Reshma Ramachandran who is an assistant professor ofdr medicie at the yale school of medicine, an expert ensuring equitable Patient Access to safe and Effective Health technologies. Dr. Ramachandran, thanks very much for being with us. Chairman sanders, Ranking Member cassidy, and distinguished terms of the committee. Thank you for the invitation to testify today. My name is Reshma Ramachandran, a assistant professor of medicine ideal school of medicine why codirect and Interdisciplinary Research and policy program called the yale collaboration for regulatory rigor integrity andd transparency. Ian am also a primary care physician at a federally qualified Health Center in new haven, connecticut. Im honored to testify before you today. I remarks with a puddle is not that of my employers who the organizations i work with. Anyone with the declaration of covid19 as a bulk of emergency will come to an end. With vicious reauthorization of pahpa comes an opt in to reflect on this and utilize the Lessons Learned from dispersing significant Public Investment led to the rapid and successful developing vaccines and therapeutics. To inform this Legislation Congress should answer the following fundamental question. R how can we ensure the American Public has equitable access to medical countermeasures developed in response to Public Health emergencies in the future . Looking back at the covid pandemic the federal government effectively remove manufactures risk and developing vaccines and treatments by granting direct Public Investment as well as access to scientific expertise and resources across agencies. In return the American Public underwrote these investments have received a little careri ta they will have equitable sustainable access when the Public Health emergency inns. Instead manufactures have announced plans to raise prices exorbitantly ignoring at even lower pandemic prices they been able to reap billions. Without intervention from the federal government my most bobo patients including those without Health Insurance as well as those at high risk of severe illness what disproportionally bear the burden of such untethered price hikes. While current policies are some measure of protection for insured americans, in removing cautioning for vaccine they will likely confront these prices indirectly in the form of higher premiums. The federal government and torturing vaccines and therapeutics will bear these expected increase costs. Further increase in taxpayer spending on the publicly funded medical countermeasures will mean there will be less money and Resources Available for other critical Public Health interventions to prevent future researchers or address of the threats. Moreover, twisted in public and private procurement of another publicly funded vaccine that of influenza these initial covid19 vaccine prices following the public of emergency period will likely be the floor forio continued price hikes in the future. So what Must Congress concluded as a part of pahpa to protect the American Public in their investment . First congress should empower federal, to accept necessaryry leverage with allocating funds for the filament of countermeasures and negotiatedas procurement contracts. Through bulk purchasing agreements the government could mitigate the impact of substantial price increases during negotiated lower price as it did during the covid19 pandemic. To prevent further these prices and continually rising do after you as a habit of the vaccines the government should call for ceiling price to be upheld. Additionally similarlyly to what theyve been able to negotiate in a few contracts the government could insure manufacturers given the best price compared to that of other high Income Countries. Besides securing reasonable provision the government must not sacrifice access and complaint safeguards within these contracts and the kinds of flex ability and speed. The use of contracting mechanisms such as other transactional authorities handed the building of the government to remove unnecessary access barriers to taxpayerfunded medical countermeasures such as unaffordable pricing. Instead, allocation of any such funds should be tied to provisions p that confirm the supported medical countermeasure is indeed safe and meaningfully effective. During an ongoing Public Health emergency it may be acceptable for these parts remain at the time of market authorization however, the government mustfe condition taxpayer funding on thee completion of additional studies that verify they do indeed work as intended and the answer of the important Public Health questions be on authorization and approval. Understand had different treatments and vaccines compared to one another or across different populations better informed the government in determining how t many doses of each individual product and at whatat price. Covid19 demonstrated how effective the government can be in inspiring measures. How will the success of these efforts should not be measured by whether these medical products reach they market. Rather Congress Must ensure the success under pop pop is red as give acting as a student of taxpayer funds and interequitable access are truly effective and safe Health Technology in return. Thank you. Thank you very much. Our next witness is mr. Roberts weissman, who is president of Public Citizen mr. Weissman is an expertxp specific ensuring a critical access to drugs. Mr. Weissman thanks a lot for being with us. I given much, chair sanders and Ranking Member cassidy for the opportunity to be here today. I think its fair to say operation warp speed wasei a grt success in speaking to the development of w Covid Vaccinesa validation of the bard investment model, to an extent. But it was also a great failure and we need to learn that lesson as well. It was a failure in that although the u. S. Government was responsible for funding the Covid Vaccine from before covid even emerged, to the isolation of the key spike protein come to the Clinical Trials and up through the development and production of the vaccine. Barda imposed effectively no restraint on how moderna and of the parties but especially moderna would operate. The result was while moderna executives became billionaires, taxpayers were price gouged. Hundreds of thousands or maybe millions of people lost their lives because we had a global shortage of a vaccine that couldve been avoided if we shared the technology. And now moderna has announced it plans to quadruple, further limiting access, further gouging consumers, further gouging the taxpayer. As of what you has agreed we need to learn the lesson from what happened during thegr pandemic and you better Going Forward. We absolutely need pahpa. We need barda but we need to do better. What are some key lessons Going Forward . First we need more transparency in the contracting process. Taxpayers should know who theyre providing grants to come within making acquisitions from and on what terms. Ro when Drug Companies and vaccine makers are making coinvestment and a product they should know, taxpayers should know how much is being done on the private sector side along with the public side. Second, we need to have reasonable pricing for the products that we the taxpayers pay for. That should be common sense. If we pay for it, we ought not to pay for it again with unreasonable prices. The starting point for reasonable pricing should be that the United States does not pay more than other high Income Countries do for a product but thats just the starting point. We can do much better than that. In general the way we should think about reasonable pricing is tailoring a reasonable price to the amount of private Sector Investment and risk taken. Where the government pays for the government of the drug all the way through, the reasonable price should beof a lot lower tn where private sector partner took on a lot of the risk and made a lot of earlystage investments. Third, we have to guarantee International Access but we know pandemics definitionally mean that everyone around the world needs the productsno we are talking about. Drug manufacturers, vaccine may not have to pass, often out of interest in serving the global markets. As such we should have a proactive requirement for licensing to the World Health Organization of Crucial Technology and licensing and sharing of technology and noah as well to make sure of the manufacturers can produce products that everyone needs. Last, we should consider as well as the traditional model for supporting research and Development Prize models such as those that you support in the past with legislation, chair sanders. We know in the case p of barda that the patent monopoly model support innovation by definition doesnt work. Thats why barda is making the investments because the private sector model in these cases as commissioner said earlier, doesnt work. Its at least insufficient. Given that we ought to think creatively about what might work better. Prizes can be calibrated to provide appropriate incentives sufficient to enable manufacturers and researches into the space while also ensuring affordability andit access on the backing. They can also do other things to promote innovation like giving people rewards when they dont actually get the final product but they make contributions along the way. These are some of the lessons i think that come out of the pandemic and that we must incorporate into pahpa Going Forward. Thank you very much. Thank you very much. Senator cassidy, did you want to introduce your panelist. We are joined today by dr. Martin mccoury, a researcher, profess at the Johns Hopkins of medicine professor Johns Hopkins carey business school. Dr. Markary focuses research and Public Health and healthcare derivative issues range from contra costa covid19. Covid19. He proves it worked the World Health Organization or help develop surgeons checklist which is help reduce surgery related deaths around the world. He completed his medical training at georgetown Johns Hopkins and is the author and coauthor of over 250 250 peerreviewed papers. Dedicate that right . Pretty impressive. Look for hearing from you today. Thank you for joining us. Thank you. Thank you, senator sanders, thank you Ranking Member cassidy and thank you, senator markey that its a privilege to present. I speak him have a soft and not Johns Hopkins university for the National Academy of medicine of which i am a member. Congress should avoid the false narrative that insufficient federal findings were to blame for our pathetic covid response. Take for example, one Johns Hopkins student created a cobra tracker that the world used, and it was not created by the 21,000 employees at the cdc. As a bad effect when hhs met with the cdc, they said it would take months to create such a tracker. Did cdc meet one of 5000 employees or 50,000 employees . We just had the head of aspirin the assistant secretary of preparedness and response essay, she needs more hiring power. How about firing power for incompetence, or both . I mean, 21,000 employees cannot come up with a cobra tracker . More tragically, the nih has 42 billion. Barda which is a part of the pahpa act has another billion dollars and they couldnt do the most basic Clinical Research we need it done quickly to answer the basic questions, to end the controversies and the conspiracy theories, to finally get out the questions americans were asking us, how does it spread . Is it from Touching Services . Do i need to port 20 cows of our call on my groceries . Fauci was telling teachers in july to wear gloves and goggles. Or once a spirit airborne . That couldve been answered and 24 hours in one of our labs. Or in one week of Clinical Research to answer the question, when are you most contagious . What is the peak day of virus shedding . How long to have to quarantine for . Two masks work . We couldve answered this with definitive basic Clinical Research early. They didnt. And so i think its fair to ask how did they