March 11, 2020 - Issue: Vol. 166, No. 47 — Daily Edition116th Congress (2019 - 2020) - 2nd Session
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CORONAVIRUS; Congressional Record Vol. 166, No. 47
(Senate - March 11, 2020)
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[Pages S1698-S1699] From the Congressional Record Online through the Government Publishing Office [www.gpo.gov] CORONAVIRUS Mrs. BLACKBURN. Mr. President, I will have to tell you and all of my colleagues, as they probably know, this has been a fairly tough month for my fellow Tennesseans. As you know, last week, a tornado tore through eight counties. This started in West Tennessee and exited through Middle Tennessee up on the plateau of our great State. This left multiple communities absolutely devastated. We have mourned the loss of life and livelihoods and property. I want to, again, thank President Trump for coming to Tennessee to offer his support and for listening to those who were so adversely impacted by this storm and for being there to encourage the emergency management officials, the volunteers, and all of the elected community officials. We have been encouraged that our Tennesseans have been joined from volunteers all across the country who have shown up to help. They have donated their time, their supplies, and their money to our restoration and rebuilding and recovery and cleanup efforts. To all of those who have volunteered and offered their support, you have made such a difference in the lives of so many Tennessee families. We know this is going to be a long and difficult recovery. After all of this occurred, on Wednesday of last week, Tennessee health officials confirmed our first case of coronavirus. It was in a patient just south of Nashville in Williamson County. With all that said, that is a lot to handle in any given week, but Tennesseans and all Americans should be encouraged that there is a lot of good work that is taking place. As I said, the rebuilding efforts span all of those counties in our State. And then, of course, right there in Nashville are efforts to combat the spread of the 2019 novel coronavirus. The Vanderbilt University Medical Center's Denison Lab is one of the top 20 labs in the world that is studying this disease. For over 25 years, they received Federal grants for their research into how these viruses make us sick, and they are currently helping with the development of treatments, anti-virals, and vaccines to deal with coronaviruses, and especially the COVID-19. I am just so pleased with the progress they are making. Today I want to draw attention to a threat that has, again, been highlighted because of this coronavirus outbreak. Pharmaceuticals are no different from other products in that they [[Page S1699]] are usually manufactured in pieces--the active ingredients in one place and the inactive ingredients in another place and so on. Currently, only 28 percent of the facilities producing active pharmaceutical ingredients--and you will hear these referred to by the acronym APIs-- only 28 percent of the facilities producing these APIs are in the United States. What this means is that American consumers rely heavily on foreign-sourced drugs in order to stay healthy. Meanwhile, the number of Chinese facilities producing these APIs has more than doubled since 2010. Think about that. Only 28 percent of all the facilities globally are in the United States. China has doubled the number of facilities in China that are producing these APIs. Why does this matter? Last year, experts at the FDA testified before Congress that while the United States is a world leader in drug development, we are falling behind in drug manufacturing. We do all the R&D here. We have the great scientific minds here. They are creating these products. They are manufactured primarily in China. Their testimony identified the cessation of American manufacturing of APIs as a key health and security concern because it created vulnerabilities in the U.S. supply chain. The FDA is not alone in their concerns. In its 2019 report to Congress, the U.S.-China Economic and Security Review Commission revealed ``serious deficiencies in health and safety standards in China's pharmaceutical sector.'' That is not something that somebody just read on the internet. It is not an assumption. That is the 2019 report to Congress from the U.S.-China Economic and Security Review. The coronavirus outbreak is drawing much needed attention to the possibility of a global health crisis. Indeed, today the WHO classified it as a pandemic. I have to tell you, I think awareness is not enough. If the Congress does not act, our dependency on China for medications will continue to put American lives at risk. Yesterday, alongside my friend, the Senator from New Jersey, Mr. Menendez, I introduced the Securing America's Medicine Cabinet, or the SAM-C Act, to encourage an increase in American manufacturing of APIs. The act would expand upon the Emerging Technology Program within the FDA to prioritize issues related to national security and critical drug shortages and bring pharmaceutical manufacturing jobs back to the United States. In addition, the SAM-C Act authorizes $100 million to develop centers of excellence for advanced pharmaceutical manufacturing in order to develop these innovations. These centers will be partnerships between institutes of learning and the private sector. The number of API manufacturing facilities in China is still growing. It grows every single day. Although we cannot yet quantify our dependence on China's APIs, we do know the more Chinese products flow into the United States, the more potential there is for trouble. In 2007 and 2008, 246 people died as a result of adulterated Heparin, a widely used blood thinner. An investigation by the Centers for Disease Control determined that batches of Heparin manufactured in China had been contaminated. The contaminant, which is very cheap, was similar in chemical structure to Heparin and went undetected in routine tests. Since 2010, regulators have also found serious problems with batches of thyroid medication, muscle relaxers, and antibiotics. In 2018, the FDA recalled a number of blood pressure medications made in China that were contaminated with cancer-causing toxins. To be perfectly clear though, adulteration isn't the only concern. In 2016, an explosion at a Chinese factory resulted in a global shortage of an important antibiotic because that factory was the drug's sole source of production. Think about that. The factory exploded, and there was a shortage of an important antibiotic because they were the only people who were making it. Without intervention, the FDA expects the pharmaceutical industry will continue to rely on Chinese companies to make these active pharmaceutical ingredients, the APIs. On February 27, 2020, the FDA announced the shortage of one drug that was used to treat patients with the coronavirus. They attributed the shortage to difficulties obtaining--guess what--the active pharmaceutical ingredients from a site in China that has been affected by the disease. The status quo has made us vulnerable, but the fix is sitting right in front of us. If we fail to act, we are placing our future in the hands of unregulated foreign countries we know to be bad actors. We have a lot of work to do before we will be able to call our supply chain and our healthcare delivery systems secure. But if we are learning anything, we are learning we need to bring this production back into the United States where there is proper oversight, where we know we are not going to have contamination in this supply chain for these active pharmaceutical ingredients. We must embrace telehealth, especially across State lines, and halt the breakdown of care in our rural areas. I have introduced bills that will help support those things, and I welcome additional cosponsors. The door is always open. All of this activity is here to secure our supply chain and our ability to access the healthcare that Americans need. Today I specifically ask that our colleagues support S. 3432, the SAM-C Act, Securing America's Medicine Cabinet Act. That is a first step in securing this pharmaceutical supply chain and securing the health and wellness of American consumers. I yield the floor. I suggest the absence of a quorum. The PRESIDING OFFICER. The clerk will call the roll. The legislative clerk proceeded to call the roll. Mr. McCONNELL. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. The PRESIDING OFFICER. Without objection, it is so ordered. ____________________
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