Monday, March 9, 2020

COVID-19 Exposes America's Drug Outsourcing

To the shock of many Americans, the coronavirus has exposed a glaring weakness in the country's pharmaceutical supply chain.  U.S., drug firms, in the name of efficiency and profits, have outsourced most of the manufacturing of medications to other countries, primarily China.

A Department of Commerce study found that an alarming 97% of all antibiotics sold here are imported from China. A stunning 80% of raw drug ingredients used in pharmaceutical manufacturing come from China and India.  The development has been well known for decades by industry insiders.

Between 2003 and 2013, imports of Chinese pharmaceuticals skyrocketed 192%.  At last count, there were 1,585 drug manufacturing plants in China, generating $138 billion in revenue. The industry employs more than 710,000 people.  Some of those plants and jobs were once located in the U.S.

Most of the generic drugs sold at American pharmacies are imported from China.  Key ingredients for blood pressure medicines, heart disease, Alzheimer's, Parkinson's, epilepsy and depression are made in China.  America has become frighteningly dependent on China's supply chain for key drugs.

Consumer Reports research discovered many brand-name drugs are also produced overseas, often in the same plants as the generic equivalents.  With its vast pharmaceutical industry, China has an unhealthy monopoly on the production of drugs the world depends on to treat patients.

As one illustration, the base ingredient for the widely used penicillin drug is manufactured almost exclusively in China.  Nearly half of the Communist country's output is shipped to India where it is repackaged into dosage form for export.  The last penicillin plant in the U.S. closed down in 2004.

Most dietary supplements and vitamins sold in the U.S. are made overseas, the majority in China, according to ConsumerLab.com.  It is nearly impossible for consumer to find out the country of origin of the ingredients.  Often the U.S. distributor is listed on the label, a confusing practice.

The are two main reasons this outsourcing threatens Americans.  The first is the rigorous U.S. government inspections are delegated to understaffed groups in China, putting drug safety at risk.  The second is the utter dependence on a country whose leaders are bent on world domination.

Not long ago the Federal Food and Drug Administration (FDA) had an undermanned staff of 13 inspecting Chinese plants.  In 2014, the FDA conducted a total of 46 inspections in China's sprawling drug industry.  The FDA has since boosted its China staff to 29,  but it is still woefully inadequate.

The Government Accountability Office (GAO) found that FDA inspections of Chinese drug manufacturing plants were infrequent at best and some were never visited.  All 217 U.S. pharmaceutical manufacturers are inspected by the FDA every two years.

Relying on Chinese inspectors has proven grossly ineffective. In 2008, contamination of a raw ingredient imported from China and used to manufacturer the blood-thinning drug heparin was associated with at least 81 deaths in the U.S.  And there have been scores of other safety issues.

During an 18 month period from 2018 to 2019, the FDA announced more than 50 recalls of blood pressure medications because the active ingredient valastran was found to be contaminated with trace amounts of jet fuel.  The FDA reported it caused cancer in one of every 8,000 patients.

For American patients, it is unrealistic to take drugs only made in the U.S.  Barbara Young, editor of a publication for the American Society of Health-System Pharmacists, made that clear when she wrote: "These days it is very hard for (consumers) to track where your drugs come from."

As she explained, often drugs are repackaged and rebranded along the production and manufacturing process.  Pharmaceutical distributors often don't disclose the country of origin on the product's label.  Even if queried, it is often impossible for retailers and wholesalers to obtain the information.

That issue has temporarily taken a backseat to concerns the coronavirus will create drug shortages as Chinese plants are shuttered. The FDA reported a shortage of one drug connected to the virus, but declined to disclose it.  At least 20 other drugs that rely on ingredients from China are in short supply.

In addition, India announced that it is restricting the export of 26 drugs and ingredients to ensure its country has supplies of antibiotics.  The action will further limit stockpiles of medications destined for the U.S.  If the coronavirus expands, the situation could become critical for U.S. patients.

America is now in the uneasy position of being held hostage by what happens in China and to a lesser degree India.  Should Americans care that China is the world's pharmacy leader?  Yes, because if China slams the door on exports of medicines, U.S. hospitals and clinics could no longer function.

China's stated policy is to achieve world dominance economically and militarily to relegate America to also-ran status.  The regime's "China First" directive is driving the huge buildup in the drug production industry.  What if the Chinese decide to use drug supply as a weapon?

That question may sound hypothetical at this juncture, but it worries the Defense Health Agency, which provides health care and prescription drugs to the military.  The acting director has pointedly stated "the national security risks cannot be overstated."

Those are sobering words that should awaken American policy makers, Congress and the U.S. pharmaceutical industry.  Continuing on the current outsourcing path puts every American's health in jeopardy.  The nation needs to respond by repatriating its drug manufacturing to the U.S. 

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