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.

advertisement

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.

Leave a Comment

Please enter your name.
Please enter a comment.

  • There is always India as the API manufacturers., many of them actually have facilities in the US. Their chemists and pharmaceutical development scientists are highly educated, many actually obtained their advanced degrees in the US, and he best part is there would not be any language barrier! The trade group PhRMA would surely look into and address this issue in due time.

    Look at the plight of Apple, with something like >30 suppliers in China and huge revenue there:

    China is Apple’s third-largest market, with nearly $52 billion in sales in the company’s most recent fiscal year, mostly from iPhone sales.

    Tim Cook must not be sleeping well these days…

  • You fail to mention that many of the high-level workers in that industry would need H1B or other alien type visa’s (indians, chinese and many other country’s citizens that have worked here in the past in Pharma–AND would NOT be welcome by the president nor yourself– so as usual, a republican without understanding of actual markets.

    • Ian McCloy: I am from NJ originally. That was and still is the pharma capital of eh United States. Let me tell you this: We used to manufacturer our drugs and delivery systems in NJ. And we did it with local labor. Several family members, all with high school educations only, worked at these facilities for decades. Two of my cousins with higher education, worked in the labs. What the heck are you talking about? We don’t need H1B visa applicants to manufacture drugs in the US. We need job openings; the bodies are already available.

  • If nothing else this article should motivate anyone to start taking responsibility for their own health! If one stays away from processed crap food and eats a healthy diet consisting of whole organic real foods they can avoid this Big Harma nightmare altogether. Hippocrates said it well, “Let thy food be thy medicine and thy medicine be thy food “.

  • Just found out I get my life saving drugs from China. Not so good; also we get parts for our war machines from China ….. Insanity. We need to make things here in the USA. Only then will we be Great Again. Let me know what I can do to help rectify this. I wrote to Sen. Toomey ……… CRICKETS

  • It was only about an hour and one half ago on this same website known as Stat that i wrote on a different article as to the devoid .null deprivation .lack of concern . going about our own business most of which are elementary . mediocrite lack of substance and virtue . Well there fore this Magnificent .Profoundly so and Enlarge speaks for itself as to where we are in Society . Earth .Universe or some where else . not to appears doom or bust yet still i am one not to disregard the clear and overwheming decay of any form of urgency , attention along with actions that will positively address the Chaos that we are in this Society . Once more the social media stands convicted . Apple Computer regain their status last week of being a one point five trillion dollars Conglomorate . Gorilla or Magnet . with sales of nine hundred ninety seven billion dollars with the unread purchasing apple phones some that begins prices at two thousands dollars such as the folding phones . yet still these buyers are unaware of the Empire such as Apple .Trevor 4, 26 p.m eastern standard time . New York City.

  • This is like closing the barn door after the horses get out. Pharma industry propagandists told us it was not safe to import drugs from Canada. The FDA is no longer functioning in any capacity, they do not even have the qualified staff to inspect these facilities. Years of politicians corrupted by industry cash, underfunded the FDA and removed key positions. They replaced them with industry insiders, who undermined their ability to regulate anything. The FTC has suffered a similar fate, unable to keep up with massive deceptive public health propaganda and marketing campaigns designed to mislead the American public. Even CMS is not allowed to track the number of adverse events from defective foreign pharmaceuticals. The FDA is still hiding the reports, or not even collecting them. Collecting data on any of this would not be good for industry profits.

    To think! The Indsutry told us that importing drugs from Canada, “could be dangerous.”

    The pharmaceutical industry and the FDA, through greed and incompetence, have lost their standing globally. Other nations can no longer trust the FDA, which used to be the gold standard. Lying, cheating and price gouging, when it comes to our health, should be a crime. Our regulatory agencies have proven they cannot function in any capacity. We live in the Age of Greed!

    • DO you watch movies? Have you ever watched the Wall Street? Do you remember what Mike Douglas’ character (Gordon Gekko) said?

      “The point is, ladies and gentlemen, that greed – for lack of a better word – is good. Greed is right. Greed works. Greed clarifies cuts through and captures the essence of the evolutionary spirit.”

      I would add the “evolutionary spirit” specifically refers to capitalism.

      What you said is not restricted to the drug industry. Look at oil, airline, energy, insurance, etc.

      If you really hate it so much here, why don’t you move to Canda. I am sure you can access all the great drugs there you might need cheaply and easily without resorting to “importing”!

Your daily dose of news in health and medicine

Privacy Policy