FDA's Failure to Inspect Overseas Drugmakers Puts U.S. Lives at Risk | Opinion

The United States is waking up to an emerging health care crisis. And it's something that most Americans might not have noticed before the COVID-19 pandemic. The U.S. is now dangerously dependent on foreign manufacturers for essential, lifesaving medicines. The problem is growing worse, too, since the overseas producers on which the nation depends for its generic drug needs are repeatedly violating Food and Drug Administration (FDA) safety standards. Despite this, pharmacies across the country continue to dispense these medicines.

Potentially unsafe drugs arrive in the U.S. each day. It's happening because overseas drugmakers simply face far less scrutiny than domestic U.S. drug manufacturers. The FDA frequently issues "warning letters" to these overseas factories for these safety violations. But nothing gets fixed.

Consider this: Americans take an estimated 131 million prescription drugs each day. And 90 percent of these prescriptions are filled by generic medications. The United States is now reliant on imports for at least two-thirds of these generic drug needs. And nearly 90 percent of the active pharmaceutical ingredients that the U.S. needs to manufacture medications are also made overseas.

This poses a double problem. It not only threatens patient safety, but it also poses competitiveness challenges for America's remaining pharmaceutical producers.

A good example is Aurobindo Pharma, America's largest supplier of generic drugs. Aurobindo's factories in India have been repeatedly cited by the Food and Drug Administration (FDA) for unsafe manufacturing practices.

Earlier this year, the FDA issued a warning letter to Aurobindo regarding "significant deviations" from safe manufacturing practices. And in 2019, federal regulators warned Aurobindo of "repeated failures" to address safety concerns, including "contamination at levels above the acceptable limit" and "inadequate cleaning procedures." Just last month, Aurobindo recalled doses of a prescription blood thinner that was found to be "subpotent."

It's not just Aurobindo, though. Pharmaceutical manufacturers in China and India routinely receive similar warning letters from the FDA for production safety violations. These include carcinogenic ingredients in medicines as well as manufacturing processes that can result in "fatal infections in a broad array of patients." Incredibly, 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.

If that sounds troubling, consider the tremendous difference between the FDA's scrutiny of overseas drug factories and its in-person inspections of domestic U.S. pharmaceutical producers.

In order to ensure that U.S. pharmaceutical plants uphold the highest safety standards, the FDA conducts unannounced, in-person inspections at domestic facilities. This means America's drug producers must maintain pristine, around-the-clock production standards. That can slow down production, since U.S. drugmakers are required to wait for FDA oversight in order to gain drug approvals.

However, the FDA's inspection of overseas drug manufacturers is far more lax. The FDA simply conducts pre-announced, virtual inspections of overseas facilities. This is the equivalent of planning a Zoom chat with an overseas factory just to remotely ensure that safety standards are being followed.

This huge disparity between domestic and overseas inspections provides a tremendous advantage for drugmakers in India and China. And even the FDA recognizes the problem. Last year, the FDA admitted: "We recognize that remote interactive evaluations do not replace inspections, and that there are situations where only an inspection is appropriate based on risk and history of compliance with FDA regulations."

The FDA's lopsided inspection process certainly isn't helping America's pharmaceutical industry keep pace with overseas competitors. Quick virtual approvals mean that foreign drug factories can begin exporting products to the U.S. long before America's pharmaceutical plants can gain a similar opportunity. The result is more lost market share for American drug producers.

The answer is for the FDA to visit and inspect drug manufacturers in China and India. There's an urgent need to test the drugs being supplied to U.S. patients—and to fully insist on safe manufacturing facilities. Until the FDA can do that, it must hold overseas drug producers accountable—and ban unsafe imports. It's past time to take action before another health crisis puts American lives at risk.

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

The views expressed in this article are the writer's own.