The coronavirus outbreak exposes the U.S.’s pharma supply chain vulnerability

Sen. Marsha Blackburn

Stat News

February 14, 2020

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.

Read the rest of Senator Blackburn’s op-ed in Stat News.