Why is the FDA Allowing Unsafe Drug Imports?

In 2008, contaminated heparin blood thinner from China killed 81 Americans. Since then, unsafe drugs from China have continued to be a serious concern. In 2018, for example, the Food and Drug Administration (FDA) ordered the recall of another prescription drug made in China—the blood pressure medication valsartan—due to concerns regarding carcinogen contamination.

The United States has become heavily dependent on overseas drug manufacturers—particularly in China and India—for essential, lifesaving generic medicines. As a result, the United States now relies on imports for at least two-thirds of its generic drug needs. And nearly 90 percent of the active pharmaceutical ingredients that the U.S. needs to manufacture medications are also produced overseas.

It’s a major concern—that the U.S. relies on imports for its drug needs. And the safety of these generic prescription medications is also in question. 

Consider Aurobindo Pharma, the nation’s largest supplier of generic drugs. Aurobindo has repeatedly been cited by the Food and Drug Administration (FDA) for unsafe manufacturing practices at its factories in India. However, despite over a decade of contamination issues, product recalls, and safety concerns, Aurobindo continues to supply millions of Americans’ daily medication needs.

Earlier this year, the FDA issued a warning letter to Aurobindo citing “significant deviations from current good manufacturing practices.” At the same time, Auromedics Pharma LLC, a subsidiary of Aurobindo, was forced to recall shipments of an injectable antibiotic. 

The FDA has experienced trouble with Aurobindo since 2011. And in 2019, federal regulators warned the company of “repeated failures” to address safety concerns, including “contamination at levels above the acceptable limit” and “inadequate cleaning procedures.”

If that’s not enough, Aurobindo recently received three new notices from the FDA for potential violations of the Food Drug and Cosmetic (FD&C) Act.

Aurobindo isn’t the only overseas drug manufacturer with a track record of safety concerns. Pharmaceutical manufacturers in China and India routinely receive “warning letters” from the FDA regarding production safety violations. These include defective ingredients in medicines and manufacturing processes that can “result in fatal infections in a broad array of patients.” Incredibly, though, the FDA has not made in-person inspections in many of these facilities in recent years and has not visited any drug factories in China since 2019.

Why is the FDA allowing unsafe drug imports for millions of U.S. consumers? Federal regulators have repeatedly issued warning letters to overseas drugmakers. But they’ve taken no further action. In 2019 alone, the United States imported $127.6 billion worth of pharmaceutical products. No one really knows how many of these drug imports are truly safe.

The American people understand that there’s a problem. A recent poll by Morning Consult found that 84 percent of voters want the FDA to halt imports of generic medicines from foreign manufacturers that have received warning letters. And 72 percent say they oppose importing any generic drugs from China.

An over-dependence on foreign drug production has left America deeply vulnerable. The answer is for the FDA actually to visit and inspect drugmakers in China and India. There’s an urgent need to test the drugs being supplied to U.S. patients—and to insist on safe manufacturing facilities fully. Until the FDA can do that, it must hold overseas drug producers accountable—and ban unsafe products.

Michael Stumo is CEO of the Coalition for a Prosperous America (CPA). Follow him @michael_stumo.