- - Wednesday, August 14, 2019

ANALYSIS/OPINION:

The trade dispute between the U.S. and China has rightly earned worldwide attention, as the two largest economies in the world place tariffs on specific goods.

China’s military continues aggressive actions in the South China Sea and a violent crackdown against Hong Kong could come any day.

Below the surface, China poses a different, but potentially deadly threat to the U.S.

Recently the Trump administration declared that Chinese manufactured ingredients in generic drugs are a “national security risk,” due to these knockoff drugs being both ineffective and unsafe.

The Pentagon has specifically cited this risk to U.S. troops and civilians, as China has become the world’s foremost supplier of active pharmaceutical ingredients (API).



The White House National Security Council is studying this issue and the Chinese drug manufacture industry, with a goal of identifying which medications offer the greatest risk. This follows a recent one-year recall of a tainted heart medication, valsartan.

At the Pentagon, the Defense Health Agency, which administers prescriptions drugs to active duty personnel, is required by law to purchase drugs only from the U.S. or compliant countries, excluding China. However, up to 150 drugs have waivers because of limited supply availability.

The valsartan recall, which began in July 2018, was caused by a “probable carcinogen” known as NDMA, which was manufactured by Zheijiang Huahai Pharmaceutical Co. Its faulty manufacturing process went “undetected” for four years, according to the U.S. Food and Drug Administration.

According to The New York Times, “the tainted valsartan came from a Chinese manufacturer, Zhejiang Huahai Pharmaceutical Company,” and was distributed in the U.S. by generic giant Teva Pharmaceutical Industries, among other companies.

Rosemary Gibson, in testimony to the U.S.-China commission, recently said, “We wouldn’t have our aircraft carriers and nuclear submarines built in China, and for very important medications, we really should look at what it takes to purchase based on value, not just price. We want cheap, we can buy cheap. But what’s missing from the whole equation is quality.”

The conventional wisdom in Washington is that generics are good because they bring down health care costs. But cost cannot be the only concern.

The first priority of our policymakers should be to protect Americans from unsafe medicines. Chinese generics make Americans less safe.

And a reliance on foreign medicines from hostile powers leaves us susceptible to shortages if China were to cut off drug shipments to drive leverage in other foreign policy or trade negotiations. Unsafe Chinese generics don’t just threaten national security by potentially delivering poisonous medicines to our troops, but also the general population.

With the passing of the Hatch-Waxman Act of 1984, generic drug manufacturers became incentivized by speed over quality with a “first-to-file” rule.

The New York Times warned that the FDA is not up to the task of taking on a worldwide monitoring program, and “with Big Pharma using saturation advertising to drive demand for its expensive drugs, an overmedicalized society is demanding more and more drugs sooner and cheaper. At the same time, even brand-name companies are increasingly hiring poorly regulated Indian and Asian plants to make their ingredients or formulations — just as the generic industry is being prosecuted for price-fixing. The entire drug supply, as one prominent American cardiologist concluded, is ‘sick.’”

Foreign countries simply do not have robust drug manufacturing regulations. While generic drug approvals are up 95% since fiscal 2014, global surveillance inspections dropped 11% in fiscal 2018.

The combination of more generic prescription drugs with foreign ingredients and fewer international inspections is a recipe for a public health disaster.

• Matt Mackowiak is president of Austin, Texas, and Washington-based Potomac Strategy Group. He’s a Republican consultant, a Bush administration and Bush-Cheney reelection campaign veteran and former press secretary to two U.S. senators.

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