The FDA has repeatedly cited India’s Aurobindo for unsafe manufacturing practices, but still lets it dominate the U.S. market
By Michael Stumo
Last Updated: Aug. 12, 2022 at 9:05 a.m. ET
First Published: Aug. 11, 2022 at 4:15 p.m. ET
What’s deeply concerning is that the nation’s largest supplier of these generic drugs, Aurobindo Pharma 524804, +3.10%, has repeatedly been cited by the Food and Drug Administration for unsafe manufacturing practices at its factories in India. However, despite more than 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 (CGMP) for active pharmaceutical ingredients.” 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.
Despite these repeated safety concerns, however, the FDA just granted Aurobindo’s subsidiary, Eugia Pharma Specialties Ltd., approval for an injectable drug used to treat certain types of cancer. 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 carcinogenic ingredients in medicines as well as 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.
The United States has become heavily dependent on these foreign drug manufacturers—particularly in China and India—for essential, lifesaving generic medicines. This is the result of heavily subsidized overseas drug producers artificially lowering their prices to put many U.S. pharmaceutical companies out of business. As a result, the United States is now reliant 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 serious concern—that the U.S. is reliant on imports for its drug needs. In fact, during the COVID pandemic, China and other countries banned exports of essential medicines—including antibiotics and antivirals—in order to maintain needed supplies at home. As a result, U.S. hospitals were left scrambling to deal with shortages of basic medicines.
The FDA is continuing to allow substandard and unsafe drug producers to export generic medications to U.S. consumers. Federal regulators have repeatedly issued warning letters, but taken no further action. This is the equivalent of simply rubber-stamping shoddy drug manufacturing methods. And the numbers involved are staggering since the United States imported $127.6 billion worth of pharmaceutical products in 2019 alone.
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 fully insist on safe manufacturing facilities. Until the FDA can do that, it must hold overseas drug producers accountable—and ban unsafe products.
The American people agree. A recent poll by Morning Consult found that 84% of voters want the FDA to halt imports of generic medicines from foreign manufacturers that have received warning letters. And, 72% of voters say they oppose importing any generic drugs from China. That’s sensible, considering that contaminated batches of heparin blood thinner from China killed 81 Americans in 2008.
The U.S. once led the world in pharmaceutical manufacturing. But today, the United States no longer manufactures penicillin—and has virtually no capacity to produce antibiotics, among many other lifesaving medicines. This over-dependence on foreign production has left America deeply vulnerable. It’s past time to rebuild the nation’s domestic drugmaking capacity—and do so before another health crisis puts more American lives at risk.
Michael Stumo is CEO of the Coalition for a Prosperous America, a bipartisan advocacy organization representing farmers, ranchers, manufacturers, and labor organizations that make and grow things in the United States. Follow him at @michael_stumo
This article was originally published on MarketWatch. To view the original article, click here.
We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.