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President Trump has said we are fighting an “unseen enemy” right now, and he is right. The coronavirus COVID-19 pandemic has swept the world with countries, including the United States, taking unprecedented steps to protect their citizens and slow the spread of the virus.
This pandemic is also an important wake-up call. It has shown that the pharmaceutical supply chain has shifted in recent decades to predominantly producing a variety of products in Asia, including finished medications and active pharmaceutical ingredients (APIs).
Many drugs that have been around for decades, such as ibuprofen and penicillin, began production overseas at the expense of domestic production here in the United States. It’s estimated that 90 percent of antibiotics, vitamins and pain relievers – drugs that Americans take every single day – come from China. As a pharmacist for more than 30 years and currently the only pharmacist serving in Congress, I know firsthand that we cannot allow this foreign dependence to continue because a disruption in the supply chain or a shortage of drugs could be devastating for every day Americans – and we are facing that reality today.
Chinese state media has made recent overtures that they may prioritize utilization in their own country rather than ship overseas to countries like the United States. And in just the past few weeks, India announced that they would be withholding exports of API products overseas – 26 in total – posing a severe risk to American consumers that desperately need these drugs.
It is abundantly clear that the U.S. has a significant vulnerability when it comes to the production of APIs and other drugs in foreign markets.
While U.S. drug companies still lead the world in the development of cutting-edge pharmaceutical products, we’ve fallen behind on the production of basic drugs and ingredients. India is the number one producer of generic drugs in the world – supplying 18 percent of the world’s generic medicines. But even India relies on China, with 70 percent of the APIs used to manufacture medicine in India coming from China.
We are not just seeing larger percentages of the ingredients needed for production being made overseas. The United States doesn’t even have a firm grasp on how much is actually produced abroad for the supply chain.
In October, Janet Woodcock, the director for the Center of Drug Evaluation and Research, testified before me and my colleagues on the Health Subcommittee of the House Energy and Commerce Committee. She explained that while there was an acknowledgment that a majority of API production is done abroad, we don’t have an accurate assessment of those products and how much is now done overseas. Estimates predict this number could be upwards of 70 percent, and the number of FDA registered facilities making APIs in China has more than doubled in the last decade. It’s also alarming that in addition to not knowing how much is actually produced in China, we also don’t know where it’s being distributed.
Much like the oil embargoes of the 1970s when America realized we needed to become energy independent, we now need to focus on pharmaceutical independence. We cannot afford to have the United States beholden to foreign production and interests, especially when it comes to something like life-saving medications. This is not only about health care. It’s also about our national security.
First, we must have an accurate assessment done so that we know how much of our pharmaceutical needs are produced overseas, especially APIs. Without that data, we cannot properly prepare.
Second, we have to look at how we can transition this production back to the United States. My office is currently working on policies that will help increase domestic production through incentives, updated manufacturing policies, and tax relief. The federal government needs to create an environment that brings drug manufacturing back to American soil. While doing this, it’s important that we learn from our past mistakes – like when we saw extreme abuse of incentives for pharmaceutical manufacturers to relocate to American territories.
Third, we need to maximize all available outlets, including compounding pharmacists. As we experience national shortages of basic sanitary products like hand sanitizer, they can play a larger role in helping to meet those needs. I have successfully worked with the Food and Drug Administration to allow compounding pharmacists to produce hand sanitizer during the pandemic when they are usually banned from making “commercially available” products. These health care professionals are here in America and they are able to help meet the health care demands of American consumers. They should be allowed to do it.
Finally, we need to continue exploring advanced manufacturing techniques where necessary. We must utilize advanced technologies like mobile manufacturing facilities. If we have the ability to deploy the manufacturing of needed treatments to hot spots, we can more effectively save lives.
President Trump has made clear that we need to focus on America first. I can think of no more important "America first" mission than achieving pharmaceutical independence. This will help us better prepare for the possibility of future pandemics, and it will ensure Americans are able to access the medications they need when this is all over and we return to our day-to-day lives.