Congress and Administration Need to Reduce Dependency on Foreign Drug Supplies
Americans want medicine to be there when they need it, yet the Food & Drug Administration (FDA) last month listed shortages of 124 drugs. The list includes drugs such as atropine sulfate, which treats low heart rate, many vaccines, and hydrocortisone tablets, for severe allergies and breathing problems. Congress and the Trump Administration need to take further steps to reduce the reliance on supply chains that originate in China and India.
One problem is that other nations are producing drugs cheaper than they are currently produced in the United States. The U.S. continues to be the leader in research and development of new medicines, yet we are not the leader in manufacturing of drugs. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, testified before Congress in October 2019: “in recent decades, drug manufacturing has gradually moved out of the United States” and “this is particularly true for manufacturers of active pharmaceutical ingredients (APIs), the actual drugs that are then formulated into tablets, capsules, injections,” because “as of August 2019, only 28 percent of the manufacturing facilities making APIs to supply the U.S. market were in our country.” Woodcock cited the statistic that “the remaining 72 percent of the API manufacturers supplying the U.S. market were overseas, and 13 percent are in China.” That fact has created a dependence that has become a national security issue in the era of the coronavirus pandemic.
Although this issue predated the COVID-19 crisis, demand for medicines to treat the virus have created a massive crunch. Suppliers are running low on drugs like Remdesivir, a therapeutic used to combat coronavirus, and cheaper generics like fentanyl citrate, a painkiller, and cisatracurium, a muscle relaxant, which are two drugs used for patients on ventilators. When looking at the critical medicines needed to tackle the pandemic, only one in five are produced domestically.
On May 19, 2020, President Trump’s Department of Health and Human Services (HHS) announced a plan to work with a private industry partner, Phlow Corp., to expand “pharmaceutical manufacturing in the United States for use in producing medicines needed during the COVID-19 response and future public health emergencies.” The release cited a partnership with other American entities including APAC Fine Chemicals, an API manufacturer with facilities in California, Texas, and Virginia; Civica Rx, a non-profit U.S. generic company set up by hospitals and philanthropies to alleviate drug shortages; and the Medicines for All Institute at Virginia Commonwealth University, which is developing new technologies to produce generics at lower cost. This is the template for how the federal government can help private enterprise compete with nations employing cheap labor; and to level the playing field with foreign governments that leverage state resources to prop up their domestic manufacturing.
This type of public/private engagement will allow American companies to stockpile Rx drugs in anticipation of the next pandemic. BioSpace recently reported that the goal of this agreement was to allow “the U.S. government to build a reserve of key ingredients used in the manufacture of essential medications in order to reduce the burden of reliance on foreign sources and bolster the nation’s drug manufacturing infrastructure.
In March, Sens. Tom Cotton (R-AR), Marsha Blackburn (R-TN) and Ted Cruz (R-TX) introduced S.3537, the Protecting Our Pharmaceutical Supply Chain from China Act of 2020. According to Sen. Cotton’s press release, this legislation would allow tracking of pharmaceutical ingredients and transparency in the supply chain; the bill would create economic incentives for American companies and it prohibits “pharmaceutical purchases from China or products with active pharmaceutical ingredients created in China.”
This is not a partisan issue when you see that former Vice President Joe Biden is campaigning on the issue of implementing “fundamental reforms that shift production of a range of critical products back to U.S. soil, creating new jobs and protecting U.S. supply chains against national security threats.” Biden has promised to “identify critical drugs and medical products and create a market for American manufacturing by directing federal agencies to purchase versions of these [key] drugs that are made in the U.S."
Congress should toss aside partisanship and negotiate an acceptable version of Sen. Cotton’s bill to start the process of reducing America’s dependence on foreign sourced drugs. The Trump Administration should continue to engage American companies to produce more domestic ingredients for drugs. Even in our hyper-partisan environment, protecting and enhancing America’s Rx drug supply chain is an easy call.