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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.

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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.”

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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.

  • It seems to me that vitamin supplements and other consumable pills and capsules should also have full protection from anti-US countries. Millions of Americans could be sickened by enemy actions without these safe guards.

  • Three years ago when filling out a Trump survey on issues concerning Americans I expressed my concern about food and medications being imported to the US from China. This was years after the tainted Chinese dog food incident, but before the carcinogen-contaminated blood pressure med scare. We should have never entrusted production of such important commodities as food and life-saving medications to the evil Chinese regime. It is past time to bring pharmaceutical production back to the US! Thank you, Sen Blackburn, for this well-written opinion piece. I, for one, would appreciate greatly if you could work to encourage our American pharmaceutical companies to bring drug production home. American health safety and national security depends on it! #MAGA/KAG

  • I NOW FIND MYSELF UNABLE TO FILL MY RX FOR BLOOD PRESSURE MEDS WHICH ARE MADE IN CHINA . SO I KNOW VALSARTAN IS ONE OF THE MEDS ON BACK ORDER BY MANUFACTURE IN CHINA. WAKE UP AMERICA WE NEED TO GET THESE DRUGS MADE IN USA….. THIS VIRUS SHOULD BE A WAKE UP CALL

  • Please bring all medical supply and prescription drugs manufacturing back to the US. These should not be produced in China and India just to save a few pennies, especially when the pharmaceutical industry is making a fortune on drugs. The drug pricing needs to be addressed immediately. I have a medication that costs $1,450 per month if I have to pay for it. Luckily the drug reps GIVE IT AWAY to my doctor, who passes the samples on to me because I can’t afford this medication that I really need.

  • Very dangerous relying on China for our drugs, very dangerous. Who knows what the Chinese KGB could put in the next batch of drugs, to cause some very serious health issues. Please bring the jobs back to the USA!!

  • Thank you so much for such valuable information…
    I do worry about this issue. What a shame we have neglected such an important part of our citizens safety.
    My husband has Parkinson’s and blood clot problems and his medications are crucial to him and to many others. We’re counting on your care and vigilance.
    We appreciate you,you go girl!!!!!

  • We need to get started making these drugs in the US. These countries could wipe a lot of people out instead of war with contaminted drugs. No excuse for this.I worked as a Med Tech for over 40 yrs, and I know there must be strict guidelines on the work you do.

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