Barney has the best intentions, but he does not have the experience in knowing common sense of how the law and how business and how other people, not just his own self. Hes up against a situation here i dont even think that biden understands that he really is going to be tossed aside when he if he is elected. He is going to be made a fool of. Host what did you think President Trump accomplished last night . Caller i think trump was fantastic. And thats why it amazed me at like about how he acted sheriff taylor. He really made more sense. And reasoning out these things. And came forward with the right answers. Host ok. Mary in florida. Back to john. Wanted to follow up on that caller a few calls back on the issue of super predators. A fact check website we refer to, plitty fact, taking a look at that word specifically and whether joe biden had used it in the past. President trump saying that biden called africanamericans super predators when he pushed the 1994 crime bill. Politifact finding no evidence of that. Heres the fact check from on that. In a november 18, 1993, Senate Floor Speech biden spoke about doing something for young people who did not supervision or structure or opportunities. He said the country needed to focus on them because otherwise a portion of them would, quote, become the predators 15 years from now. Biden did not single out africanamericans. Quote, madam president , we have predators on our streets and society has become because of its neglect created that, biden said, according to the congressional record from that speech. The term super predator also came up during the 2016 president ial campaign between trump and hillary clinton. They pointed out that clinton in 1996 used the term super predator when referring to gangs of kids. Clinton did not specifically label super predators as africanamericans, but the context of her speech and subsequent apology decades later suggest it was a reasonable inference. That again from politifact. Com. One of those Fact Checking websites out there. All of them in sort of oscar mode yesterday when it comes to the president ial debates. And well go through more of those throughout todays program. Host gene from new york saying moderators should chair maloney pursuant to the ladies guidance of the house attending physician, all individuals attending this hearing in person must wear a facemask unless they are speaking. Members who are not wearing a facemask will not be ecognized. A few reminders for those members appearing in person. You will only see members and witnesses appearing remotely on a monitor in front of you when you are speaking in what is known in webex as active speaker view. The timers visible in the room directly in front of you. For members appearing remotely, i know you are all familiar with webex by now, let me remind everyone of a few points. First, you will be able to see each person speaking during the hearing. Whether they are in person or remote. As long as you have your webex set to active speaker view. If you have any questions about this, please contact the Committee Staff immediately. Second, we have a timer that should be visible on your screen when you are in the active speaker with thumb mail view. Third, the house rules require that we see you, so please have your cameras turned on at all times. Fourth, members appearing remotely who are not recognized should remain muted to rim did minimize background noise and feedback. First i will recognize members verbally, but members retain the right to seek recognition verbally in regular order members will be recognized in seniority order for questions. Lastly, if you want to be recognized outside of regular order, you may identify that in several ways. You may use the chat function to send a request, you may send an email to the majority sthaff , or you may staff, or you may unmute your mike to seek recognition. Obviously we do not want people talking over each other. So my preference is members use the chat function or email to facilitate formal verbal recognition. Committee staff will ensure i am made aware of the request and i will recognize you. We will begin the hearing in just a moment when they tell me they are ready to begin the live stream. Are we ready . Chair maloney the committee will come to order. Without objection the chair is authorized to declare a recess of the committee at any time. I now recognize myself for an Opening Statement. Good morning, and thank all of you for being here today. A year and a half ago on january 29, 2019, our former chairman, elijah cummings, held this committees first hearing of the new congress. The topic of that hearing was the same issue we are examining this week, the astronomical price increases of Prescription Drugs. Chairman cummings cared deeply about this issue. As the very first witness to come before our committee, we invited ms. Antoinette warsham. You may remember her. She testified about the devastation of losing her daughter who had to ration insulin because she simply could not afford it. Since chairman cummings is not with us today, id like to ask the committees indulgence to play a short clip of his Opening Statement from that hearing. Mr. Cummings i have been waiting a very long time to hold this hearing. For the past decade i have been trying to investigate the actions of Drug Companies for all sorts of drugs, old and new, generic and brand name. We have seen time after time the Drug Companies made money, hand over fist, by raising the prices of their drugs. Often without justification, and sometimes overnight. While patients are left holding the bill. The pharmaceutical industry is one of the most profitable in the world and one of the most powerful. 14 Drug Companies each made more than 1 billion in profits just in the Third Quarter of 2018. And they have the best lobbyists money can buy. Let me be clear, there are powerful interests here that do not want us to interfere with those massive profits. But there is a strong bipartisan consensus that we must do something, something meaningful, to reign in rein in the outofcontrol price increases. Even President Trump has said that Drug Companies are, quote, getting away with murder, end of quote. But tweets are not enough. We need real action and meaningful reforms. We all recognize that research and Development Efforts on groundbreaking medications are made immeasurable contributions to the health of americans. Including new treatments and cures for diseases that have affected people for centuries. But the bottom line is that the ongoing escalation of prices by Drug Companies is simply unsustainable. This is a matter literally of life and death, and we have a duty to act now. Our constituents are demanding it, and i am grateful we are finally starting down the road with this hearing. Chair maloney i remember chairman cummings at that hearing, so very well, sitting right here in this very chair listening intently to ms. Worshams testimony. His fierce determination, his embassy empathy. I remember how he promised at the end of that hearing to do everything in our power to make sure no family ever faces this situation again. At that moment, chairman cummings was in the process of launching our committee on one of the most comprehensive and indepth investigations of drug pricing ever conducted by congress. Today, 18 months later, i am honored to report some of our initial findings. At the time outset its important to note that Drug Companies make products we all need. We rely on this industry. To develop critical new therapies, treatments, and vaccines. But our committees investigation has revealed deeply troubling facts about how these Companies Price the drugs we all rely on. Our committee has now reviewed more than a million pages of documents from some of the largest and most profitable Drug Companies in the world. These include internal Corporate Strategy documents and communications among top executives. Let me briefly describe three Main Findings from these documents. First, the documents show that these price increases are unsustainable. Either for Government Health programs or patients themselves. The documents have reviewed that we reviewed show that Drug Companies continue to raise prices while raking in record profits and continue to put their products further out of reach for patients in need. To start this weeks backtoback hearings, we will hear today from the c. E. O. s of three companies. We will hear from the former c. E. O. Of celgene, and the former c. E. O. Of bristolmyerssquibb which acquired celgene last year. These Companies Sell the cancer drug, ref limb i had revlimid. They have tripled the price of this drug since 2005. Today a course of this drug is a ced at more than 16,000 month. Thats just per month. We will also hear from the c. E. O. Of drug company, teva, which sells the mull tip sclerosis drug, copaxone. The Company Raised the price of this drug 27 times in 1997. A yearly course is now priced times 00, nearly seven higher than when it was first introduced. To put this in perspective thats more than the median household entire income for the year in the United States. Second, the document reveals by the Committee Show that these massive price increases are based on generating windfall profits for these companies, their shareholders, and their executives. We have all heard the talking points from the Drug Companies and their lobbyists, claiming they need to raise prices to pay for research, a lifesaving medications that pharmacy middlemen are driving up the prices. Or that they are committing significant funds to helping patients who cant afford the drugs. But the committees investigation shows that those claims are utterly bogus. They do not hold water. The documents we reviewed showed that time and time again Drug Companies hike prices to meet their earnings targets. And in some cases so executives can get their personal bonuses for the year. Finally, these documents show that Drug Companies are targeting the United States for the biggest price increases in the world. They know the federal government is currently prohibited by law from negotiating directly with Drug Companies to lower prices for medicare beneficiaries. This may be the sparkest finding of all. I was astonished to see some of the new documents we will be discussing today. The United States is where the Drug Companies are increasing their prices. Much more than in any other country. And this is where they are making billions, billions of dollars in profits. Last december, the house passed h. R. 3, and we named it in e of Elijah E Cummings cummings, lower drug costs now act. This would authorize medicare to negotiate directly with Drug Companies for lower prices. President trump supported this change on the campaign trail, but unfortunately he broke his Campaign Promise and he now opposes the change. The white house issued a statement declaring that if h. R. 3 were presented to the president , quote, he would veto the bill, end quote. Instead of taking on the pharmaceutical industry like he promised, President Trump appointed former industry executives to key positions. Ese included joe grogan, former director of white house domestic policy council. He personally wrote an oped opposing h. R. 3 one week before we passed it in the house. Here is the bottom line. As a result of President Trumps reversal, drug prices have continued to skyrocket under his tenure and drug Company Executives have continued to get rich. A recent report found that Drug Companies have raised the list prices of more than 600 Single Source brand name drugs by a medium of 21. 4 just between january, 2018, and june 20 june, 2020. By any measure President Trump has failed to rein in outofcontrol drug prices. There is no doubt that he has been scrambling ahead of the election. He promised to hand out a paltry 200 discount cards, but he failed to explain how this will help people facing tens of thousands of dollars in drug costs. The president also claimed he is banning u. S. Companies from charging more than they charge abroad. But experts expose this tiny demonstration project as a transparent and futile attempt to create the impression of action where there has not been any. Let me close with this. As chairman cummings would have wanted we need to focus on the people this affects the most. I would like to place statements from two patients who want to share their experiences with us about these two drugs. And we will now play the atient videos. Im randy. Im 50 years old. From minnesota. Im a sing many mom with two kids in college. In 2018 i was diagnosed with an incurable cancer called multiple myeloma. Before my diagnosis i was a High School Math teach earn Long Distance learner. Now i can no longer do either. I rely on a drug called revlimid to keep me alive. My outofpocket costs are about 15,000 a year, which is impossible for me to cover on my fixed income. In order to keep taking this drug, will i have to deplete my life savings, cash out my 401k, and sell my house. When those funds run out im not sure what ill do. Usually im a planner but can i not plan for this. I am terrified for my future. My circumstances make me feel helpless at times, but im grateful that i can share my story with all of you. I urge you to consider patients like me as you work to hold Drug Companies accountable and fix this broken system. Thank you. Hello, my name is therese, im 66 years old and i live in portage, indiana. I spent my life working as a nurse. Watching people drug struggle to afford Prescription Drugs. I never thought it would happen to me. Until 2003 when i was diagnosed with multiple sclerosis. Shortly after my diagnosis, i began taking copaxone which costs 1,800 per month at that time. After one year, of paying for my treatment, i wiped out my savings. And after that, i had to rely on grants to cover the costs. In 2017, i lost my grants and at that time the price of copaxone had risen to 6,000 a month. I could no longer afford it. So i went without the drug. When i was not on the drug, i lost shortterm memory and experienced other declines in my cognitive functions. This makes it difficult for me to enjoy the things that i love, like spending time with my grandchildren. My condition shouldnt progress faster just because Drug Companies want to make a few extra bucks. This Drug Company Price Gouging needs to change. As each of you works to reform this system, i hope youll consider patients like me. Thank you. Chair maloney thank you. I recognize the Ranking Member for as much time as he would like for his Opening Statement. Thank you, chairwoman maloney. I appreciate you calling this very important hearing today on the issue of drug prices. This is a critical issue for my constituents. Indeed for all of our constituents. And im committed to working with you to identify and implement reforms that will improve access and affordability to Prescription Drugs. This concern is also shared by the president. Over the course of the last three years President Trump has taken bold steps to address drug prices. Mr. Comer under the Current Administration drug prices have fallen nearly 13 . Under President Trump a Record Number of generic drugs have been approved, saving americans tens of billions of dollars. Under the Trump Administration, terminally ill patients are given a chance to explore innovative treatment options. So we are all in agreement that drug pricing is a crucial issue for us to consider. However, im worried, madam chairwoman, about the apparent intentions of the majority in holding this weeks hearings. Instead of considering potential reforms in a productive and bipartisan manner, these hearings seem designed simply to vilify and publicly shame pharmaceutical Company Executives. A productive set of hearings would consider the pros and cons of various reforms and would seek to retain the politics there the Current System while identifying imprompt fprofments for necessary and possible. Instead, democrats seem eager to cast our witnesses as villains and place all blame for cost and access issues on the private sector. The causes i think are far more complicated. Many of the greatest Health Care Initiatives and innovations in the past 100 years have happened in america. And they have happened not because of government dictates but as a result of the tireless work of individuals having the freedom to experiment and compete and improve all of our lives. At this moment in time the entire world is cheering on the pharmaceutical industry to find a safe and effective vaccine to stop covid19. Thats the path to a more complete return to normalcy. To reopening our economy. To getting our kids back to school. And getting parents back to work. Under the Trump Administration we are seeing the fastest a Vaccine Development in history. Its unprecedented. A mere 43 days passed between sequencing of the coronavirus, r and a, and start of the Vaccine Development. As dr. Fauci an others safety is not being sacrificed, but the Financial Risks are high. Im hopeful democrats on this committee can stop the repeated attacks on the Vaccine Development process which do nothing but undermine the efforts of so many government and private sector scientists. Returning to the matter before us today, the policy challenge is ensuring we dont kill the mowive to develop new cures while at the same time taking targeted steps to address specific concerns regarding cost and Patient Access. The problem, madam chairwoman, is not that the free market has failed. Rather the problem is that overly complex regulations and government interventions in the market have distorted incentives and created barriers to competition. I dont believe that more bureaucracy is the answer. We must rethink regulation that is distore processes and ensure adequate competition happens in the marketplace. And, yes, we should consider any needed reforms to what the founders envisioned as a limited guarantee to profit from an invention that at times has been distorted into an unlimited ability to exclude others from selling similar Prescription Drugs. I look forward to hearing from todays witnesses will how best to ensure that america remains at the forefront of innovation and discovery while addressing Prescription Drug pricing and accessibility. I hope we choose to do that in a man theyre takes into account the complexities of modern pharmaceutical development and the lifesaving innovations companies such as those appearing before us today have provided us all instead of creating false and simplistic narratives about the private sector. Thank you, madam chairwoman, i yield back. Chair maloney thank you. I now recognize ms. Foxx, the Ranking Member of the committee on education and labor, for her Opening Statement. Ms. Foxx thank you very much, madam chairman. Many americans pay too much for drugs. Its not right and Congress Needs to step up. Luckily we have a solution that can lower costs at the drugstore for patients and seniors. This solution can be passed into law before the election. The lower cost more cures act, h. R. 19, the republican alternative to democrats h. R. 3, combines many bipartisan reforms to lower outofpocket spending, protect access to new medicines, and cures, strengthsents transparency, and champions competition. To the contrary, democrats h. R. 3 would actually eliminate 38 new drugs over the next two decades, new drugs that could cure alzheimers, cancer, or covid19. H. R. 19, the republicans bill, would make research and development more competitive by reducing companies ability to game the system and engage in anticompetitive behavior. H. R. 3 would hide the cost of Prescription Drugs behind a wall of medicare bureaucracy. The republican bipartisan bill on the other hand would require Insurance Companies and p. B. M. s, to be more transparent where drug costs would be available to patients at the Doctors Office before the prescription is even written. H. R. 3 makes no effort to require pharmacy benefit managers to pass rebates from manufacturers to patients. H. R. 19 would require that a portion of rebates to p. B. M. s be passed directly to the patient at the point of sale. Saving seniors millions of h. R. Millions. H. R. 3 attempts to use the power of the government to steal companies intellectual property, to decrease the cost of a drug in the short run. H. R. 19 clears the way for more generics and biosimilars to come to market, increasing competition, rapidly driving down costs for patients, and ensuring access to new innovative medications. H. R. 3 ignores the cost of administering cancer treatments for medicare beneficiaries. H. R. 19 cuts the cost of chemotherapy in half by providing incentives for high quality care instead of merely giving priority to the location of treatment. Instead of passing commonsense reforms contained in republicans h. R. 19, democrats have chosen to discard months of bipartisan work and conduct this partisan hearing to attack companies that are working to help the American People. Democrats had a choice to help americans or help Speaker Pelosi. Sadly they chose to help Speaker Pelosi thank you again, madam chairman, i yield back. Chair maloney thank you. I now recognize mr. Hice, the Ranking Member of the subcommittee on government operations, for an Opening Statement. Mr. Hice thank you very much, madam chair. As my colleague from North Carolina just mentioned, h. R. 3 really would completely gut the pharmaceutical innovations which we also desperately need and we rely upon. In fact, the Congressional Budget Office said that it would result in 38 fewer cures over the next 20 years. Thats a significant number. They also estimated that it would result in as many as 100 fewer cures from coming to the market. Just think of that. 100 cures from coming to the market. We just saw a video. It could result in potentially a cure from deadly diseases like multiple sclerosis. Like we just saw. Or alzheimers or even covid19. We dont need to have cures that could potentially come to the market not coming to the market. But ao cording according to c. B. O. Thats what would happen with h. R. 3. By the way, these cures dont come cheap. It is not unusual for some of these medications to cost as much as 2. 5 billion through r d to come to the market to begin with. And thats not even to mention, not even to consider the fact that more than 90 of these drugs that enter into f. D. A. Clinical trials never gain f. D. A. Approval. So weve got enormous expense with these companies trying to bring medication to the market. 90 plus of which never make it to the market. And so let me just be clear. The f. D. A. s rigorous process is a huge reason why so Many Americans trust that the medications and the vaccines that come to market are safe. And dependable. And unlike many of my colleagues on the other side of the aisle, i trust the process. I know that it will bring a safe and effective vaccine to the American People for covid through operation warp speed. Biopharmaceutical companies are far outspending the federal government for r d for cures for various diseases, and thats exactly why we need to be willing to work in order to make innovation easier so that more americans can live fuller and happyier lives. Not killing happier lives. Not killing innovation with government. Im sad to see todays hearing shows, frankly, at least in my opinion, that my colleagues on the other side of the aisle are not interested in a bipartisan solution to bring more cures to save american lives. Instead they think its more beneficial for their reelection campaigns to attack pharmaceutical executives. I greatly think that is a huge mistake for the American People. With that, madam chair, i appreciate the time. I yield back. Ms. Schultz thank you. I now wreck chair maloney thank you. I now recognize congressman roy, the Ranking Member on civil rights and Civil Liberties for an Opening Statement. Mr. Roy i want to thank you, chairwoman maloney. Thank you for giving us time to have Opening Statements. You didnt have to do that. We are grateful that you did so. We all recognize prices are a major concern to all americans because lives literally depend on their existence, availability, and effectiveness. The drug pricing issue is heavily focused on blockbuster biological drugs. That costs money. Consider 4 of perfect scrigses are biolodgics. 9 o of the drugs showed in the United States are generics and relatively inexpensive. Lets have a hearing. Lets keep perspective on focusing them on solving the problem as a whole rather than vilifying certain actors. Lets not play the game. The game in washington is to clearly target one industry for political purposes who of course in this case we are talking about Drug Companies. Of course they have plenty of blame to share for the high prices of drugs. Hardly all the blame. Lets look at pharmaceutical benefit managers. The patent and trademark offices. Insurance companies. The f. D. A. Hospital corporations. Of course the government regulations, federal, state, and local. Last year in a hearing one that all members may have five legislative days to revise and extend their remarks colleagues who happens to no longer be part of the committee, katie hill, was eviscerating a drug companier, a company that makes h. I. V. Lifesaving drugs for making a profit. I said something to the effect of i hope you make a profit. But with the caveat this type of invasion saved my life when i was battling hodgkins lymphoma. And we rule out the swamp games played in regulated crony profit versus the profit that drives innovation and save lives. Many of us have had our lives saved by the innovative work assigned around the globe. Chaurm cummings, who we all met, i was glad you played that video, noted these Companies Make money off patents wrap around government research. I agreed we should address that. I think most of us do. But he also specifically gave me time to highlight my life story and perspective and pulled me aside after the hearing to agree that we must have innovation. That we must ensure we have the drugs to save lives. And i would note, the companies are working overtime to produce covid vaccines. You raised the issue how the Companies Price their drugs. Its a troubling situation. We have allowed a complex morass of of government regulations couple with Insurance Companies to have total control of our Health Care System. Empowering p. B. M. s and Major Hospital corporations to control over customers because there is no market. There is no doctorpatient relationship that enables patients to price things properly in a market. This is a problem that congress is largely created. We want to address t we need to look at the entire supply chain from top to bottom. If you look specifically like in 2018 on patents, a type of insulin had 74 patents providing protections from competition. Making it harder for diabetics to access cheaper insulin. This is what happens with limited competition. Since 2016, the f. D. A. Has approved roughly 2,500 generic versions of 620 brand named drugs. Pharmaceutical drugs with at least four generic competitors reduced the price of the brand drug by an average of 39 . The fad fat is costly and inefficient. On average it could take more than a decade and 2. 6 billion in Research Costs to get a new treatment through the f. D. A. Into the market. And only one in a thousand drug formulas ever get to preclinical testing. Only 8 get approval. Once the drug clears the la brint of patent law and f. D. A. , the drug still has to make it on the formulary of your Insurance Plan in order for you to receive your discount. The Health Care Bureaucracy this body has created is guilty of lining the pockets of these companies beyond what the market would demand. Not to forget p. B. M. s far from innocent n 2018 the United States spent 335 billion on retail Prescription Drugs. 10 of our National Health expenditure. We spent 1. 2 trillion on insurance. 34 of the National Health expenditure. Where should the focus be . The Health Care System or just farm why phrma . Our system should be able to help them defray costs. This is usually understood to happen through insurance and risk adjustments. It has become too expensive for most americans. And often its this bodys fault. The a. C. A. s regulation caused premiums to more than double from 2013 to 2017. Increased overall by 60 from 2010 to 2017 individual deductibles increase 76 . Data shows while premiums were spiking due to obamacare, unsubsidized people on the individual market were losing their coverage n two years from 2016 to 2018, unsubsidized enrollment declined by 2. 5 million people. This makes it harder to defray cost, forces many to pay the list price which could be avoidable. There are always bad factors who take advantage of the vullnefrpblt lets not Forget Congress role in creating the system causing it. I know im running out of time. Chairwoman maloney, i would point out each one of these companies are working today to engage in the fight to create a vaccine against the virus. Innovation in the pharmaceutical industry is critical. Lives are literally loss. None of us want lost. We want Affordable Drugs rather than expensive drugs that the rest of the folks biggiebacks upon the backs of americans. To do that do what this body literally never does. Roll up our sleeves. Restore Personalized Health care. Empower patients and doctors. And remove alt bureaucrats and middlemen who are the ones driving up costs. I look forward to hearing from the witnesses. I appreciate seriously the time you gave us this morning, chairwoman maloney. Chair maloney thank you. I now recognize my colleague and very good friend, congressman rush, who worked vep closely with chairman cummings on this issue, for his Opening Statement. Mr. Rush thank you very much, madam chair. I thank my colleagues. Every single american, every single taxpayer at one point or another is going to need pharmaceutical assistance. In every single american, in every single taxpayer everybody who pay as premium, every employer who pays preums on behalf of his or her employees needs relief from prices that are absolutely beyond reach. For elch the question our ongress is whether , an nment will play a role active role to stop price gouging by the pharmaceutical industry. Let me be candid. There is a disagreement about that. This legislation would enable the government on behalf of the eople it serves to negotiate prices when it purchases Prescription Drugs from the pharmaceutical industry. This is not a question of whether those are necessary. Its not a question of whether the investigatory and Research Work that phrma does is good. It is. Its about whether there is any imit on what the pharmaceutical industry can charge the taxpayer, the medicare program, the Medicaid Program, employers who provide insurance to their employees. What elijah understood is that the government that is here to serve the people has the responsibility to do things that protect them from price gouging. And, yes, its true. Many of these pharmaceutical industries have come up with lifesaving and pain relieving medications, but they are killing us with the prices they charge. And what this report shows is that there is very Clear Strategy on the part of the pharmaceutical industry to boost its prices in the place where it can, and thats the United States of america. Ours is literally the only country where the government wont protect its citizens from price gouging. Now, the profits, nothing wrong with profits. But price gouging profits, yes. Intactics used that are tried and true by the pharmaceutical industry to extend the life of that monopoly they get granted by this congress, by making an ever so slight change in the medication itself in claiming that that entitles them to extend that patent, where you have companies that are charging like 70,000 for a drug. It helps, but who can pay that . Who can pay that . And then we see the pharmaceutical industry coming up with very, very skillful ways to appear to be helping. Like donations to third party foundations that help patients of quote, afford. They have done an analysis you are going to see in this report where they very self consciously realized that that boosts sales for them and they make money by making that as an nvestment. What has happened here is that temptation that phrma has to use its uninhibited Pricing Power has transformed americas pain into phrmas profit. Thats whats happened. We can address many of the things that my colleagues have alked about with regulation. And find ways to do things that will help in the margins. But with a elijah knew is that the only way to really get fair pricing was to have negotiates negotiation. By the way, negotiation is core to a free market economy. A buyer and seller have a discussion and decide what its worth to the seller and what its worth to the buyer. We are the only buyer that medicare and Medicaid Program where we dont negotiate. And when you negotiate, you save money as vermont has done. When elijah and i met with President Trump, elijah was presenting his price negotiation plan, the president said he was for price negotiation and that phrma was ripping us off. Elijah was hopeful. The president has failed to fulfill his promise. We are here to keep elijahs commitment. Thank you, madam chair, i yield back. Chair maloney thank you. I thank you, the gentleman, for his hard work and statement. Now i would like to introduce our witnesses. We are grateful to have their testimony and i want to thank the witnesses for being so accommodating with their schedules so that we could have them here together. Our first witness today is asst. Sergeant at arms , who is the former chairman of the. Oard and c. E. O. Of Celgene Celgene sold the cancer drug, revlimid, until november of 2019. Then we go to dr. Giovanni caforio, who is the chairman of the board and c. E. O. Of bristolmyerssquibb. Bristolmyerssquibb has sold revlimid since november, 2019. Finally, we will hear from mr. Kare schultz who is the esident and c. E. O. Of Teva Pharmaceutical industries. Temba sells the multiple sclerosis drug, copaxone. The witnesses will be unmitted so we can swear them in. The witnesses will rise and raise their right hands. Do you swear the testimony you are about to give is the truth, whole truth, and nothing but the truth, so help you god. Let the record show that the witnesses answered in the affirmative. Without objection, your written statements will be made part of the record. And with that, mr. Alles, you are recognized for your testimony. Mr. Alles chairwoman maloney, Ranking Member comber, and members of the committee. Thank you for the opportunity to discuss revlimid, a life extending medicine approved by the fad if a for the treatment of rare and incurable blood cancers. My name is mark alles, i have had the privilege of being part of Research Based pharmaceutical industry for more than 30 years. Before i joined this industry, i served in the marine corps and Marine Corps Reserve and before that i taught junior high school. I have strived to bring the values of integrity, service, and respect to every part of my career. Revlimid was discovered, developed, and brought to patients by my former employer, celgene corporation. It was a global Pharmaceutical Company that specialized in the discovery, manufacturing, clinical development, and delivery of innovative medicines for the treatment of cancer and serious inflammatory diseases. I joined celgene in 2004 and after serving in multiple different roles in the company, i was appointed chief executive officer in 2016, and chairman of the board in 2018. My last day with celgene was december 2, 2019, after celgene was acquired by bristolmyerssquibb in november, 2019. At that time the company employed more than 8,000 people worldwide with approximately 5,600 employees in the United States. One of the most clinically important therapies discovered by celgene is the novel medicine marketed as revlimid. Its use is for the treatment of multiple myeloma, a rare and incurable blood cancer. It invests approximately 800 million over 14 years to invent and develop it before its first f. D. A. Approved use in late 2005. It is a unique drug that required a completely independent Development Program and full f. D. A. Approval process. It has become a standard of care for the treatment of myeloma based on several large clinical studies that have demonstrated significant patient benefits. Since revlimids initial approved, the company continued to invest severale several hundred Million Dollars into the research and development of this medicine. At the time it was acquired, celgene had and was sponsoring more than 50 additional revlimid clinical studies for patients with different types of cancer. As is common in drug development, some of these studies were not successful, did not succeed. However, several of these studies were successful and resulted in six additional f. D. A. Approvals, including the most recent in 2019. Since 2005, more than 700,000 patients have been treated with revlimid worldwide. Reflect our cing Patient Access, and reliable to the Health Care System. The continuous effort to discover new uses for existing medicines, and need for financial flexibility. In 2018 the Company Publicly committed to full pricing transparency by limiting price increases to more than once per year, and at a level not greater than the centers for medicare and Medicaid Services projected increase in thele National Health care expendy tures for the year. To help ensure Patient Access to the medicines, the Company Patient support programs providing copay assist ants to eligible, and free medicine to eligible patients. More than 140,000 people in the United States prescribed a celgene cancer medicine received some form of assistance. Celgene sold and offered to sell samples of its patented medicines to generic manufacturers so long as those companies met critically important safety standards. These requirements were established to protect the public from the risk of severe birth defects associated with a known and suspected of some of its products, including revlimid. In fact, multiple generic versions are licensed to enter the u. S. Market within the next two years. Celgene corporation was a Research Driven by a Pharmaceutical Company which invested heavily in the discovery and development of innovative therapies that are now helping to improve the lives of tens of thousands of people worldwide. In considering legislative changes, i urge congress to maintain many of the strong incentives that currently exist to encourage and support medical innovation. Finally, because my mother died from a neuro degenerative disease, my son lives with insulin dependent diabetes, my daughter has autism, and my older brother is being treated for an incurable blood cancer. All of us are severely impacted by this pandemic. This issue matters to me on a deeply personal level. I hope and believe that these incentives will lead to new treatments that society and my family will benefit from today and long after these medicines become generic drugs. Thank you. I look forward to answering your questions. Chair maloney thank you. Thank you very much. We will now recognize dr. Caforio. Ou are now recognized. Please unmute. Are you unmuted . Dr. Caforio i am unmuted. Thank you. Can you hear me . Chair maloney yes, we can. Dr. Caforio chairwoman maloney, Ranking Member comber, and members of the committee thank you for the opportunity to join this important conversation. Begun by congressman cummings, a champion for Affordable Health care and continued by chairwoman maloney. This is an important issue for all americans. Today advances in medicine are progressing at remarkable speeds. As a physician, i am excited by the science, but also concerned that without assistance to protect all patients and enable affordable access, we risk these advantages being out of reach. Medicines like revlimid highlight these advancements. And the challenges that come along with it. We have seen extraordinary gains in patients with multiple myeloma. The blood cancer treated by revlimid. The fiveyear relative survival has doubled over the past 25 years. Turning what was once a dire diagnosis into a manageable disease for some patients. Revlimid is one of the most significant contributors to this improved survival rates. We continue to unlock our Scientific Understanding of multiple myeloma, and our Research Today is fueling next generation treatments that built on revlimids success and progress. For example, we are now on the cusp of personalized medicines for multiple myeloma that use patients reengineered cells to fight cancer. We have exceptionally strong records. Both recognized for the highest R D Investments as a share across all industries. This year alone we expect to invest nearly 10 billion. As part of our efforts, we are conducting Urgent Research on covid19. Providing 1,000 proprietary compounds to partners, examining two medicines in clinical trials, and enacting a robust philanthropic response. The scientific and Capital Investment put towards developing revlimid is instructive. Thalidomide was prescribed outside the u. S. Without a thorough understanding of side effects and caused tens of thousands of infant deaths and birth defects. Celgene, however, continued to invest in its research and development for 14 years. Ultimately, this led to the invention of revlimid. Revlimid value to patients is truly immeasurable. Patients should have access regardless of ability to pay. Nor this reason, we have robust patience assistance programs, providing Financial Support to hundreds of thousands of patients with assistance and three medicines worth billions of dollars. That being said, i do recognize that patient assistance programs are an imperfect solution to access challenges. I welcome to continue to work with you and others to advance Critical Reforms that more efficiently deliver to patients and provide savings to the Health Care System. We believe in the importance of a healthy generic market and we applaud the administrations success with speeding the approval of generics. Congress hass passenger of the creates act. At the same time we must priority advertise American Innovation which leads the world in developing new therapies for patients. At bristolmyerssquibb we are committed to discovering, developing, and delivering innovative medicines that help patients. In an unprecedented year, our work has never been more critical. I look forward to answering your questions. Thank you. Ms. Schultz moip thank you. Chair maloney thank you. Mr. Schultz, you are recognized. Please unmute. Ms. Schultz thank you. Chairwoman maloney, Ranking Member domer, comber, and members of the committee. Thank you for the opportunity to appear before you today. My names Giovanni Caforio and im the president and c. E. O. Of testifya pharmaceutical industries. I understand that the committees interest in the price market, the medicine for the treatment of multiple cler rowcies or m. S. But before i discuss compassion i would like to tell you more about testifya and its role. Testifya is a global Pharmaceutical Company committed to helping patients access Affordable Medicines and benefit from innovations to improve their health. We were founded in israel 120 years ago and operate worldwide. With a significant presence in the United States. Testifyas the Global Leader in providing affordable medicine. With the industrys largest portfolio of Generic Medicines and strong portfolio of specialty medicines including copaxone. On the strength of our generic business, testifya provides access to patients and Health Care Systems around the world. For example, in the United States, testifya saved the Health Care System 41. 9 illion, including 5. 9 billion in savings by directed to patients in 2019. We also provide over 40 million worth of medicines to lmost 13,000 patients in 2019. Testifya is committed to helping patients with Scientific Research and take great pride in it. This defines how we do business and how we approach medicine. In order for any company to research and develop new drugs, the price of success for medicines must reflect the significant powers of Ongoing Research and development projects. The public only sees and pays for the drugs ultimately approved by the government, like copaxone. But you have to spend a lot of resources and endure points before safe and effective medicines. Testifya will continue to address new breakthrough treatments and find new ways to extend and expand patient care. And copaxone is one of the best examples of our dedication to Innovative Research and patient support. Our significant investments in research and developing and commercializing safe and effective treatments led us to introduce copaxone in the United States in 1996. Since then, copaxone has become a preferred treatment. Since first introduced, we have continued our studies and most recently in 2014 introduced a more efficient version of that drug that only needs to be administered three times a week as opposed to daily. This results in more than 200 fewer injections per patient each year. As a result, copaxone has been completely competitively priced based on both the value in brings to the m. S. Patients anne research and Development Needed for its continued advancement. The historical copaxone price increases of interest to the committee all created in my tenure at testifya. Testifya has not increased the list price of copaxone since january well have to leave this hearing on drug prices. You can continue watching on our website cspan. Org. The u. S. House is about to gavel back in. Its part of cspans had 1year commitment to bringing you live gavel to gavel coverage of the house. Coming up, members will debate a resolution on chinas forced labor camps which have targeted uighur muslims. Also today possible work on a covid19 aid bill. Live house coverage here on cspan. The speaker the house will be in order. The prayer will be offered by our chaplain, father conroy. Chaplain conroy let us pray. God of the universe, father to us all, we give you thanks forgiving us another day for giving us another day. During these days, these few days before the house breaks for the final weeks of the campaign, send us your spirit of peace. Inspire the members to complete their charge, to promote the common good of our nation. Comfort those who continue to suffer from the coronavirus and protect those who labor still to treat the disease and bring an effective vaccine to the world. May all
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