Coronavirus outbreak exposes a weak link in the U.S. drug supply
In the 21st century, Americans have found it far too easy to be complacent about public health emergencies like the ongoing coronavirus outbreak of the newly named Covid-19 that began in China and has since spread to other countries, including the U.S.
To be fair, it has been more than 50 years since the last federal quarantine was issued, to control a deadly smallpox outbreak. A half-century gap is bound to instill a false sense of security, even when taking more recent threats into consideration.
For most Americans, the severe acute respiratory syndrome (SARS) scare in 2003 lives on in vague memories of face masks worn by terrified business travelers. The Ebola nightmare that lasted from 2014 to 2016 wasn’t severe enough to prompt the Obama administration to issue a quarantine, much less sustain a discussion about how poorly prepared public health officials were to address the outbreak.
Fuzzy recollections are a symptom of a much larger problem: In the memory gap between outbreak and eradication lives a growing threat to health care delivery — and to national security.
In October 2019, Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, testified before Congress that the United States “has become a world leader in drug discovery and development, but is no longer in the forefront of drug manufacturing.”
Woodcock identified as a key health and security concern the cessation of U.S. manufacturing of active pharmaceutical ingredients (APIs), the basic building blocks of medications. She testified that 72% of API manufacturing takes place outside the U.S., and that the number of facilities making APIs in China has more than doubled since 2010.
The use of foreign-sourced materials “creates vulnerabilities in the U.S. supply chain,” Woodcock concluded.
Her concerns are not unfounded. The U.S.-China Economic and Security Review Commission echoed Woodcock’s worries. In its 2019 report to Congress, the commission revealed “serious deficiencies in health and safety standards in China’s pharmaceutical sector.”
The commission found a poorly regulated industry enabled by Beijing’s refusal to cooperate with routine FDA inspections. This stonewalling, coupled with the small number of FDA inspectors in the country to oversee a large number of producers and outright fraud perpetrated by Chinese manufacturers, is a recipe for disaster.
The coronavirus outbreak is drawing much-needed attention to the possibility of a global health crisis. But awareness isn’t enough. Without action from policymakers, our dependence upon China for medications will continue to put American lives at risk.
The number of Chinese facilities that make active pharmaceutical ingredients is still growing. Although we cannot yet quantify the U.S.’s dependence on pharmaceutical ingredients made in China, we do know that the more Chinese products flow into the U.S., 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 U.S. 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 was able to go undetected in routine tests.
Since 2010, regulators have found serious problems with batches of thyroid medication, muscle relaxers, and antibiotics used to treat tuberculosis, sexually transmitted diseases, and other dangerous bacterial infections.
In 2016, an explosion at a Chinese factory resulted in a global shortage of piperacillin, an important antibiotic, simply because that factory was the drug’s sole source of production.
In 2018, the FDA recalled a number of blood pressure medications made in China that were contaminated with N-nitrosodimethylamine (NDMA), a cancer-causing toxin.
Without intervention, the FDA expects the pharmaceutical industry will continue to rely on Chinese companies to make active pharmaceutical ingredients.
China isn’t alone in creating sometimes shoddy or dangerous pharmaceuticals and pharmaceutical ingredients. Companies in India also contribute to this problem.
Fortunately, policy initiatives that are popular with lawmakers have sparked the creation of 400,000 new jobs in the domestic manufacturing sector. We must focus this momentum and begin bringing pharmaceutical manufacturing jobs back to the U.S.
Congress and federal agencies can start now by reviewing regulations to ensure there are no barriers to rapid adoption of new technologies, creating incentives for workforce growth and training, and allowing the private sector to use updated, cost-effective technologies and processes that would enable U.S.-based companies to regain competitiveness in the API market.
The status quo has made us vulnerable. The fix, however, is sitting right in front of us. If we fail to act, we place our collective future in the hands of companies that operate entirely in the shadows.
It could be years before the next drug shortage or public health crisis puts Americans’ health and safety at risk — but would you bet your life on that?
Marsha Blackburn, a Republican senator representing Tennessee, serves on the Senate Commerce, Science, and Transportation Committee and the Senate Armed Services Committee.