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Reliance on Foreign Drugs

This blog is the THIRD in a new series regarding the ‘unintentional consequences’ of the COVID-19 pandemic. As our lives have been abruptly altered due to social distancing requirements – both at home and in the workplace – unplanned ‘disruption’ of previous normal activities could permanently replace sacred elements once believed to be unyielding to any change. But COVID-19 just may have dictated new approaches to how we live and work.

NOTE: Running the risk of writing a xenophobia-like piece about foreign countries, this particular blog is intended to address a serious national security issue that has been neglected for at least two decades.

To borrow a phrase from the ‘Apollo 13’ movie, “Houston, we have a problem.” No, wait, we have a BIG problem!

If the COVID-19 pandemic has taught us anything, it’s that we must not become too dependent on outside countries for drugs and certain medical supplies – such as masks, gloves, ventilators and other personal protective equipment (PPEs). These dependencies can seriously undermine our health security, which is critical to our national security. But, over the past two decades, our country HAS increasingly become more reliant on foreign countries, especially China.

Interestingly, the pandemic just may serve as the catalyst to help remedy this problem.

The China Situation

A major event occurred in the year 2000 that triggered the U.S. to rely more on China for the supply of medications. Congress and the White House agreed to grant China access to the U.S. market, and permitted China to join the World Trade Organization. Shortly after, China developed the penicillin and Vitamin C ‘cartels,’ by basically replacing American manufacturers through the dumping of low-cost product into our country. As a result, American manufacturers could no longer compete against China’s government-financed manufacturers. China’s monopolizing behavior is also commonly found in many other manufacturing products from various industries. Pharmaceutical dependence on China can be found in an earlier blog that I wrote in 2019, “Dependence on China – The ‘Weaponization’ of our Medicine.

In 2019, The U.S. Food and Drug Administration (FDA) estimated that 80 percent of active pharmaceutical ingredients (APIs) and 40 percent of finished medications were manufactured overseas, primarily in China and India. Most generic drugs, including antibiotics, accounting for more than 90 percent of all U.S. prescriptions, are imported from India, but India imports 70 percent of their active ingredients from China.

Having a high concentration of our medicine coming from just one country, no matter the country, can become a major strategic risk to the health and security of our population. To function, the U.S. (and other countries) rely on having appropriately-manufactured medicine of high-quality with safe ingredients, reasonably-priced, and readily available. In fact, by ceding the manufacturing of medicine elsewhere, any country could be held hostage by a new warfare that has never been waged in the past – the weaponization of medicine.

During a congressional testimony in October of last year, Janet Woodcock, the FDA’s director of the Center for Drug Evaluation and Research, pointed out that drug production has moved out of the U.S. into other countries.  According to Woodcock, “The FDA doesn’t know whether Chinese facilities are actually producing APIs, how much they are producing, or where the APIs they are producing are being distributed worldwide, including in the U.S.” In short, the FDA does not know how dependent the U.S. is on China for its drugs!

National Emergency Order – Stafford Act

Addressing the pandemic on March 13, President Trump declared a national emergency under the Stafford Act, a 1988 law that presidents can use to declare disaster areas after storms and other natural disasters. This declaration granted that certain medical products and supplies, such as disposable gowns and drapes, be excluded from the 25 percent tariff imposed by the U.S. since September 24, 2018, on $200 billion goods imported from China.

These tariffs have increased concern about relying heavily on a single market (e.g. China) for critical medical and pharmaceutical products, forcing many U.S. organizations to rethink their China-based supply chains. It’s additionally anticipated that the Administration is preparing an executive order that would require certain essential drugs be made in the U.S. This executive order is believed to streamline regulatory approvals for “American-made” products and encourage the U.S. government, including the Departments of Defense, Health and Human Services and Veterans Affairs, to buy only American-made medical products.

To maintain independence from foreign control, streamlining regulatory approvals for American-made products and more detailed labeling of the origin of drug products could help facilitate American production at home.

Conclusion

Whether the novel coronavirus will be the tipping point for drug makers to adopt new technologies and resist the offshoring trend is yet to be determined. Preventing an interruption in the supply of vital medications and other medical products that save lives and treat diseases – whether during pandemics or in routine care – is a matter of national security. As our population ages, Americans will become even more dependent on medications indispensable for treating heart disease, cancer, stroke – and viruses. Mobilizing resources to mitigate the supply shortages is a strategy that must be paramount to our government and all policymakers.

The COVID-19 pandemic serves as a wake-up call for our government and the pharmaceutical industry to take notice – and act. If this particular opportunity is somehow tragically missed, then policy malpractice has been undeniably committed. Regardless of the political leanings one may have, we can all agree this should not be a red or blue issue – but an American one.

Next Week’s Discussion:  Fear of virus will propel smokers to quit.

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