And delivering pharmaceuticals. The implications of one country are astounding, no matter what country we may be talking about. Think about it. What if theres a Global Pandemic and its hard to move product across the world because of that . What if there are heightened tensions within the South China Sea . Everyone could be vulnerable, everyone could be put at risk. The role of the fda in the situation cannot be overstated because the fda cannot be as effective in assuring the safety of our medicines in farflung areas of the world as it can at home. Many of us are not aware of the facetoface contact that the fda has with those who are manufacturing our drugs. The inspections that they could duck, the very hands on work that is involved in making sure that the manufacturers of drugs is safe. They certainly set up offices all over the world to do that, but thats not the same as having offices having manufactured in your own country. And with the u. S. Losing manufacturing capacity, which is continuing to happen, the situation could become even more severe. Today well discuss these Critical Issues as well as some possible solutions, and i look forward to very robust discussion. D but first let me introduce to you rosemary gibson. Rosemary gibson is a Senior Advisor at the Hastings Center and the principal author of china rx exposing the risks of americas dependence on china for medicine. She is recipientne of highest honor for th American Medical Writers Association in 2144 giving the publics of voice in their interest to Critical Issues of the day. At the George Washington gave the 2015e lecture that we have annual here at the school of Public Health. At the Robert Wood Johnson foundation rosemary was chief architect of its 250 million decadelong National Strategy to establish inpatient Palliative Care programs that now number 1600. She received the Lifetime Achievement award from the American Academy of hospice and palliative medicine, and work with bill moyers on the pbs documentary on our own terms. She is recipient of the Lewis BlackmanPatient Safety award from the South Carolina hospital association. Rosemary is also principal author of medicare meltdown, in 2013, battle over health care, treatment trap, and the the wall of silence. Her books have been reviewed in the publishers weekly, washington post, health affairs, reference and proceedings of the u. S. Ng senat, engineered congressional testimony, noted in the wall street journal, new times, a today, Consumer Reports and other news outlets too numerous to count. Rosemary is chair of the board of an institute, a Nonprofit Health system featured organization headquartered in ann arbor michigan. She graduated summa cum laude from Georgetown University and has a masters degree from the London School of economics. Please join in marketing rosemary gibson. [applause] er for now backs is the microphone working okay, wonderful. Thank you gentlemen and ladies. Good afternoon everyone. Doctor goldman, i want to thank you for making this event possible. It is a very timely and it is fitting that we are sitting here at school of health in the Nations Capital to discuss the Public Health implications as well as the National Security risks associated in the growing dependence on a single country for our madison. Its timely for another reason. The president is safe to give a major speech in the coming days and weeks about the drug prices. We know Many Americans are suffering under the burden of the high cost of medicine. But we have to be mindful of unintended consequences. Companies might feel pressured to reduce the prices and reduce their cost which could potentially drive more manufacturing to china subject to keep a close eye. Theres one lesson we draw from today its the intersection of the medicine and trade and trade policy and who would have ever thought about. I wrote this with the purpose of informing the public about this very makeshift in where our medicines are coming from. For many of us our medicines were made herein to u. S. And japan but now theres been a dramatic shift eastward. And they wrote it for my mother so my mother could read it but also for the policy wonks and academics because i think we all need access to this information. We want to trust the medicines that we take. The medicines that could mean the difference between life and death. And we need to know where our medicines come from. Why are we dependent increase in the own a single country. What are the risks and what can we do about it. I was going to bring my smartphone and medicine bottles of make believe i have it here. One of the questions i get asked the most is how come i didnt know about this. How come i didnt know that there is growing dependence in the United States on china for so many of our medicines. If you take a look at your smartphone handbook o on to at least mine says he signed in california and assembled in china. If youve ever gotten those plastic bottles with the white caps but you have to take your medicine and with the dosage is that it doesnt tell you where it comes from so there is no reason that we should know. Let me tell you about this dramatic shift and where the medicine comes from and what looks like. One of the first things weve done that has never been done before is the actually name the medicine that are being made in china by the Chinese Companies and sold here in the United States. They include antibiotics, antidepressants, Birth Control pills. A lot of young women are interested in knowing that. Medicines for alzheimers, parkinsons, epilepsy, high blood pressure, hivaids and much more. Right now china is just beginning to get into the manufacturing of genetic drugs. But it has a plan to become the pharmacy to the world and i predict within a decade, maybe less or maybe more, china could overtake india as a dominant generic drug manufacturer. Right now, the biggest footprint in the United States is making the active ingredients in so many of our madison. They are a part of our medicines that give us the therapeutic value and they make thousands of active ingredients for many of the medicines we find in our medicine chests and hospitals over the country. Many people we spoke to both former government officials and from the industry said if china should work on exports within the, pharmacies and the united gates would be empty and hospitals would cease to function. So, how did we get here . And what about other countries . One of the interesting fact is that factsthat i learned is evea which is a dominant generic drug manufacturer, even india is dependent for the active ingredients and for all materials and in many of the medicines it makes. Only not only for its own people but also for exports. There is a fascinating article in the newspaper that started out with a story of a soldier whos on the border between india and china. They share a border and there is a lot of tension in that part of the world. And so it says something to the effect a soldier on the border opens up his medical pack and sees this medicine and he is running out and dependent on the people on the other side of the border, the adversary for the components to make essential medicines. That is a fascinating situation. The article went on to say this is a National Security issue. I have yet to see an article here in the United States posing that question and talking about that here, and i applaud the media for being transparent about it in if theres any interruption in supply that would not only affect the health of the population, the military, but also a very important part of their economy because as you know, they make and export many generic drugs. The so where are we and what is the biggest risk . Is when we have the centralization of the concentration of so much of the Medicine Within a single count country. If the companies are shut down for months and months and if there is a Global Pandemic and countries have to line up for medicine, that could be a global test or the tension in the South China Sea is a hot spot right now where does that leave us that is the challenge with concentrating any imported product that we need. So how did we get here . How did this happen . Let me start with the prescription i got two months ago today. It was an antibiotic. It was amoxicillin. I was back to my old self. In the making of that particular product the government into thee industry including Companies Like pfizer made sure there was enough manufacturing capacity here in this country to help all of the Wounded Soldiers that would walk away from that event and by having that penicillin availability. The government and industry Work Together to ensure we have an adequate supply of that miracle drug. So lets fast forward a couple of decades in 2004 the New York Times reported the last penicillin manufacturing plant in the United States was about to shut down. But they didnt back story. What was really going on in the Global Market that triggered dot . Thanks to some producers that are spirited and have information on the internet about what happened in the period we can learn a little bit about what was going on in the Global Market. In 1980, china invested heavily in penicillin capacity on a number of scales. 20 years later, we begin to see the Chinese Companies coming in on the Global Market and they dumped penicillin at the low market prices and it effectively drove out American European and even Indian Companies from the business because they could not compete. The producers called this a landslide definition of their industry and then what happened there was a spectacular price increase for all of us in some way paid for. That is the only cartel that was happening. If you read about the vitamin c cartel im sure many of you take vitamin c. You might take a tablet. It doesnt come from oranges, it is made in a Chemical Plant probably in china where theres a fascinating story about the vitamin c cartel. Its the same playbook as americans, europeans and Japanese Producers of ascorbic acid and a couple of companies dumped it on the world market and drove out competitors and when they were gone they raised the price again spectacularly. With antitrust we could have a whole session today on the cartel because that story continued and theres enormous implications for a lot of our medicines and other products we get from china so we have these penicillin and vitamin c cartels and what does this tell us if told us that we are losing control over the supply of our madison. As a country we are losing control and others are dictating the price and the supply. We have to ask is this a situation that we want to be in. What was driving this and wont for some undercurrent to . We identified the generic drug laws at his 1984 but are those of you that remember if theyve generic drugs available to the public and it made them affordable for millions of people. But that meant companies if they had to sell products more cheaply were looking for a place to make them more cheaply so they picketed east to asia but at that time they were not equipped to oversee and regulate the Global Industry and what else was happening in the research is very boring life when you find all kind of things on the internet late at night and one of the interesting things i found was a memo written by a dedicate very dedia employee, a chemist and he asked the question or said we have no idea where of peaceful strikes active ingredients are coming from and they could get to the president. So we have a point of time in the United States where it was the wild west. And we didnt know where some of these products were coming from. Lets fast forward a year 2000 and it its triggered the u. S. Dependence on china and thats where congress and the white house agreed to grant china access to the u. S. Market. Its fascinating to see in a short period of time after that but the penicillin cartel was formed and was up and running the United States closed its last manufacturing plant dumped on the u. S. Market and the local producer couldnt compete without a business. Its something very important that also happened in 2004. A major Healthcare Company in the United States switched suppliers is a very important ingredient for a product they make and that is called pepper in debate heperin and its a blood thinner. If youve been to a hospital you probably have it. A couple of years after baxter switched suppliers from the u. S. To be chinabased supplier, it turns out it was the contaminated ingredient was found in the heperin product. It came from china and that there was deliberate contamination for economically motivated reasons and that there were 250 deaths in the United States associated with that contaminated the heperin. That triggered extraordinary reform, Good Progress to try to fix what we basically had a cd with deregulated environment in the countries where we were getting our madison. But it still was far from perfect. Theres a couple of lessons here. First the globalization has effectively been a form of deregulation. You dont need the law to change the structure just move production overseas and effectively deregulate. Think about this. The United States has had the highest gold standard. The good people at the fda industry developed to ensure highquality safe medicines every time. Theyve had fewer standards and its really remarkable. Back in this period in 2007, some of you might member that is report where the head of the chinese equivalent of the fda in china was executed for taking bribes and government officials said we are still at a very early stage of being able to manufacture highquality medicines. But that didnt stop the market moving to a place that if is college that had very few standards. Really it was a remarkable transition. The other thing that is fascinating, and again the lack of transparency it turned out we had a trade deficit with china at least in 2014. And ive never seen a public official in the United States acknowledged that we have a trade deficit in pharmaceutica pharmaceuticals. Maybe its there and i would love to see it if youve caught got aglimpse of it please send o me that where we did find the data point was in the speech that doctor margaret gave to a group that were probably very happy to hear there was a trade deficit with the United States and china and the pharmaceuticals. So, we have a lack of transparency. How dependent are we on china . I will give you a couple of fascinating examples. In 2015, the fda inspected a plant in china that was because it was getting a lot of customer complaints, presumably industry complaints about the active ingredients that they are getting from the plant. It was bacterial contamination at some of the products didnt have the full therapeutic value for which it is an antibiotic or chemotherapy, that could be devastating. The fda went in and found what they called systemic data manipulation. This is a plant with the chinese fda and other inspections over many years. So they banned 29 different products from coming into the United States. But because the United States is so dependent, the fda had to exempt 14 of the products from its own ban and some of those included antibiotics were in the audience for antibiotics and ingredients for chemotherapy because the fda was concerned about drug shortages here in the United States. Thats how the pen and they are as a country. There was a fascinating story about the availability of the anthrax attacks. Some of you might remember here washington and new york the u. S. Military needed to buy a whole lot so they went to a very Reputable Company in europe this was reported in bloomberg and in the course of writing that i spokthe book ispoke to the ceo y and they said yes he had to get the starting material from china. So think of it the military needed this after the attacks into the starting material was obtained from china and as someone from the industry said that if china is the anthrax attacker, medicine can be used as a strategic weapon. Then theres other examples when india said maybe our military is dependent on the adversaries for medicine i thought about the United States