Substandard generic drugs are flooding the US market and putting all Americans at risk
Despite safety concerns, hospitals keep using substandard generics and supermarket pharmacies, big box retailers and corner drug stores continue to sell them
Most Americans would be shocked to learn that millions of doses of poor-quality and potentially harmful generic drugs are being imported into the United States each year. Despite safety concerns, hospitals keep using them every day. And supermarket pharmacies, big box retailers, and corner drug stores continue to sell them.
Many in Washington will point a finger at the FDA. But the real problem is that U.S. companies choose profit over safety by importing and selling substandard generic drugs across the nation.
These U.S. companies include large group purchasing organizations and wholesalers that follow a very lucrative business model. They simply scour the globe for the cheapest generic drugs—often from China and India. For them, the lower the procurement price, the higher the margin of profit—no matter where or how the medicines are produced.
One example is a generic muscle relaxant administered to COVID-19 patients on ventilators. At the beginning of the pandemic, the drug was in short supply. In response, the FDA approved imports from a manufacturer that had received FDA warning letters. These medicines must be manufactured under sterile conditions. But the agency warned the company about its failure to prevent contamination of its supposedly sterile medicines.
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These concerns could be avoided if drug purchasers prioritized safety over profits—and purchased generic drugs from reliable manufacturers in the United States. Instead, in their endless quest for cheaper drugs, they choose to ignore safety and quality concerns.
This race-to-the-bottom for the price of generic drugs has driven ethical manufacturers out of business—and caused the collapse of America’s domestic generic drug manufacturing industry. As a result, the United States now depends on China for thousands of generic drugs because Beijing controls the supply of basic drug-making components.
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With the United States now increasingly dependent on imported medications, doctors, nurses, pharmacists, and patients are witnessing first-hand the risks that come from imports of substandard generics.
A recent medical journal study reported on life-threatening risks from a generic drug used to treat patients recovering from heart and lung transplants. Researchers found that a generic medication made by two overseas companies didn’t dissolve properly—impeding its effectiveness and posing life-threatening risks.
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Everyday medications are also failing to meet U.S. standards. The FDA warned a manufacturer of a common asthma medication, albuterol, about sterility concerns and the risk of contamination with other medicines made at the same facility.
When U.S. companies buy imported medications as cheaply as possible, they set in motion other costs. Patients suffer serious setbacks—blood pressure spikes, failed organ transplant recovery, and uncontrolled seizures—when their generic drugs don’t work.
In the worst cases, Americans die from unsafe drugs purchased by U.S. companies. In 2007 and 2008, for example, hundreds of Americans died from tainted supplies of Chinese-made heparin.
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In 2018, millions of Americans learned that their blood pressure medication contained a cancer-causing rocket fuel chemical. One Chinese manufacturer—whose product contained the highest amount of the carcinogen—was subsequently banned by the FDA.
It’s time to impose a cost on the traders of substandard imported drugs. To do so, the United States must once again manufacture these generics at home.
To realistically support America’s generic drug manufacturers as they compete with cheap imports, Congress should impose "Buy American" requirements for the Department of Defense and the Veterans Administration. Similarly, domestic procurement policies should also be extended to Medicare and Medicaid.
Americans need safe, quality medicines. Washington must not allow special interests to buy substandard drugs and sell them in the United States. It’s time to bring these vital supply chains home—so that American lives won’t be at risk.
Rosemary Gibson is Chairwoman of the Coalition for a Prosperous America’s Healthcare Committee and the author of "China Rx: Exposing the Risks of America’s Dependence on China for Medicine."