FDA Allows Unsafe Drugs From Foreign Drug Manufacturers – InsideSources


As the COVID pandemic began, the United States quickly experienced a serious shortage of personal protective equipment, including face masks and medical gloves. This happened because the United States has become heavily dependent on imports of such supplies. In response, Congress passed legislation to boost domestic production.

However, there is another medical crisis facing the nation. The United States remains dependent on countries like China and India to supply generic drugs that millions of Americans take every day. And all too often, these drugs turn out to be inferior and unsafe.

Over the past 30 years, much of America’s drug manufacturing has been offshored, including production of generic drugs, which supply 90 percent of America’s daily needs. As a result, thousands of medicines are being manufactured with ingredients that are only made in China.

The situation is dire. The United States no longer manufactures penicillin and has virtually no capacity to manufacture antibiotics such as those used to treat pediatric ear infections, pneumonia and anthrax exposure. The United States also imports 95 percent of its ibuprofen and 70 percent of its acetaminophen from China.

To make matters worse, many generic drug imports continue to enter the United States from foreign factories without proper inspection.

Of particular concern is the country’s largest supplier of these generics, Aurobindo Pharma. The company has been repeatedly cited by the Food and Drug Administration for unsafe manufacturing practices at its factories in India.

Despite more than a decade of contamination issues, product recalls, and safety concerns, Aurobindo continues to serve the daily medication needs of millions of Americans.

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

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

As if that wasn’t enough, Aurobindo recently received three new notices from the FDA for possible violations of the Food Drug and Cosmetic Act.

Despite these repeated safety concerns, the FDA has authorized Aurobindo’s subsidiary, Eugia Pharma Specialties Ltd. granted approval for an injectable drug to treat certain types of cancer.

Aurobindo isn’t the only overseas drugmaker with safety concerns. Pharmaceutical manufacturers in China and India routinely receive “warning letters” from the FDA for manufacturing safety violations. These include carcinogenic ingredients in drugs and manufacturing processes that “can lead to fatal infections in a wide range of patients.”

Incredibly, however, the FDA has not personally inspected many of these facilities in recent years and has not visited drug factories in China since 2019.

Poorly controlled shipments of medicines pose serious risks. For example, in 2007 and 2008, tainted shipments of Chinese-made heparin killed hundreds of Americans. More recently, millions of Americans were being sold blood pressure medication by a Chinese company that contained more than 200 times the acceptable limit per pill of a known carcinogen.

The United States was once the world leader in pharmaceutical manufacturing. But now the nation is heavily dependent on foreign drug production. It’s time to rebuild the nation’s drug-making capacity — and do it before another public health crisis puts more American lives at risk.

The answer is that the FDA visits and inspects drug manufacturers in China and India. There is an urgent need to test the drugs being shipped to US patients – and to insist on safe manufacturing facilities. Until the FDA can do that, it must hold foreign drugmakers accountable — and ban unsafe drug imports.


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