THE THREAT OF MEDICINE disruptions from the COVID-19 pandemic may pose a larger threat to public health than the virus itself.
Coronavirus-related supply-chain interruptions in China, which along with India is responsible for 80% of America’s generic drug supply, may cause severe shortages of essential medicines, including antibiotics, heart drugs and painkillers, in the U.S.
Last month, the Food and Drug Administration announced the first domestic drug shortage due to a manufacturing disturbance caused by the coronavirus. The number of medicine shortages will likely only grow in the coming weeks alongside coronavirus cases.
We have been warning about the threats posed by American overreliance on Chinese medicine manufacturing for years. It gives us no pleasure to say, “We told you so.”
Decades ago, most prescription drugs consumed by Americans were made in the U.S., but for tax, regulatory, and labor cost reasons, many drug companies have offshored manufacturing. U.S. policymakers and health officials should use this supply shock to finally spur the reshoring of manufacturing for the country’s most vital medicines. The status quo risks not only public health but also national security.
Due to supply disruptions from China, India recently announced that it is freezing exports of 26 essential drugs and drug ingredients to ensure its domestic population is covered. The U.S. receives roughly 40% of its generic drugs from India, which imports the vast majority of its raw materials from China. Last year, India accounted for roughly one-fifth of the world’s generic drug exports by volume.
One of our biggest fears is that China may similarly nationalize its drug supply if it cannot manufacture an adequate amount while its economy is largely idled. This move would create widespread shortages of essential medicines in the U.S., almost surely eclipsing coronavirus as the nation’s biggest public health threat.
Fortunately, Chinese manufacturers are slowly returning to work. That trend may change, however, if workers cause new coronavirus clusters to emerge.
The shortage threat is especially pronounced for generic antibiotics, classes of which China is the only manufacturer. Antibiotics are essential to treat a wide variety of common infections that otherwise would be life-threatening. They are also key in the fight against the secondary infections that may result from the coronavirus, suggesting that lack of access to them may be driven not only by supply-side constraints but also by increased demand. Most of the drugs on India’s no-export list are antibiotics.
“This first (FDA) shortage is almost certainly an antibiotic or at least an antimicrobial agent,” Ron Piervincenzi, chief executive officer of the United States Pharmacopeia, told Forbes. The U.S. shut down its last domestic antibiotic manufacturing plant in 2004.
Yet dozens of other drugs are affected. The FDA has identified roughly 20 drugs that are solely made in or derive their active pharmaceutical ingredients from China. The U.S. is partly reliant on Chinese raw ingredients for 370 medicines deemed “essential” by the World Health Organization. According to one research study, the prices on pharmaceutical raw materials have grown by up to 50% since the outbreak began.
Despite the well-publicized threat, reliance on Chinese medications has only increased in recent years. According to a U.S. government report released last year, U.S. imports of Chinese pharmaceutical materials grew by nearly one-quarter in 2017 from the prior year to nearly $4 billion.
In order to protect the generic drug supply chain, the U.S. must produce its most vital medications, such as antibiotics, insulin and anesthesia, at home. In their 2018 book “China RX,” authors Rosemary Gibson and Janardan Prasad Singh lay out 10 steps to achieve this goal. These include deeming medicines a strategic asset, providing incentives to bring manufacturing home and increasing FDA testing of medications.
More broadly, Congress must also look at the regulations, taxes and barriers that originally drove drug suppliers offshore. To develop treatments and vaccines for coronavirus and put this crisis behind us, policymakers must allow drug-makers to put as much money as possible into research.
Coronavirus must force policymakers to finally act to shore up the U.S. drug supply and foster homemade cures. Such actions would be a silver lining to the coronavirus pandemic.
Sometimes you need an in-depth knowledge and understanding of medications for your case. In such situations, Strom and Associates can be your friend. Contact us for complete expert witness services including consulting, evidence review, reports, and testimony.
Running a pharmacy business is hard. You need a helping hand to follow all the directives of the regulators. Strom and Associates can help. Contact us to have a top-to-bottom assessment of your operations.
Are you following all the government directives for distributing opioid and other controlled substances? No? Don’t worry. Strom and Associates can help you to understand the regulations perfectly. Contact us for further details.
Has a lawsuit been filed against you for allegedly negligent care in your long-term care or Assisted Living facility? Are you sure your counsel has hired the right experts? Well, that’s what Strom and Associates are here for. Contact Us to know more.