Critical drugs have been in the news lately, especially with the nation facing an import shortage of the antibiotic amoxicillin. As a senator from Florida. Marco Rubio recently observed that “this dependence on foreign countries for essential goods is dangerous and unsustainable”.
Rubio is urging fellow lawmakers to bring pharmaceutical manufacturing back to the United States, which should be of particular interest to Florida’s 4.2 million retirees. About 90% of Florida’s seniors take prescription drugs every day, putting them on the frontlines of a new health crisis – a growing wave of dangerous drugs made overseas.
This is all a consequence of America’s heavy reliance on drugmakers in India and China who repeatedly violate Food and Drug Administration (FDA) safety regulations. Florida lawmakers should carefully consider the issue to help keep the state’s elderly residents safe.
Most Americans rely on generic drugs to meet their prescription needs. But the drugmakers that supply American consumers, including Aurobindo Pharma — the nation’s largest generic drug supplier — are routinely flagged by the FDA for unsafe manufacturing practices at factories overseas. Despite this – and more than a decade of contamination issues, product recalls and safety concerns – Aurobindo continues to supply drugs to Florida and the rest of the United States.
Earlier this year, the FDA issued a warning letter to Aurobindo citing “significant deviations” from safe manufacturing practices for pharmaceutical ingredients. This is not surprising since the FDA has had issues with Aurobindo since 2011. In 2019, for example, federal regulators warned Aurobindo of “repeated failures” to address safety issues, including “contamination at higher levels borderline acceptable” and “inadequate cleaning”. . » procedures. Last month, Aurobindo recalled doses of a prescription blood thinner for being “underpotent.”
Aurobindo is not the only overseas drugmaker with a history of safety concerns. Pharmaceutical manufacturers in China and India regularly receive “warning letters” from the FDA for safety violations. These include carcinogenic ingredients in drugs as well as manufacturing processes that can “lead to life-threatening infections in a wide range of patients”. However, the FDA has not conducted in-person inspections at many of these facilities in recent years and has not visited most drug factories in China since 2019.
Why is the United States so dependent on foreign drugmakers for life-saving drugs? It is the result of heavily subsidized foreign drug producers artificially lowering their prices to bankrupt US pharmaceutical companies. As a result, the United States now depends on imports for at least two-thirds of its generic drug needs. And nearly 90% of the active pharmaceutical ingredients the United States needs to manufacture drugs are also produced overseas.
Despite this, the FDA still allows substandard and dangerous generic drugs to enter the United States. And the numbers involved are staggering. In 2019 alone, the United States imported $127.6 billion in pharmaceuticals.
The FDA must conduct in-person inspections of drugmakers in China and India — especially facilities that receive warning letters — and insist on safe manufacturing practices. Until then, the FDA should take steps to test and ban dangerous drugs.
Florida residents mostly agree. A national poll by Morning Consult found that 84% of voters want the FDA to stop imports of generic drugs from foreign manufacturers who have received warning letters. And 72% of voters say they oppose importing any generic drugs from China. Makes sense, since contaminated batches of anticoagulant heparin from China killed 81 Americans in 2008.
The United States once led the world in the manufacture of pharmaceuticals. But today the country no longer manufactures penicillin – and has virtually no capacity to produce antibiotics, among many other life-saving drugs.
All of this has left older people — especially in Florida — deeply vulnerable. Since Florida is home to one of the largest elderly populations in America, it can help lead by insisting on importing safe drugs. It’s high time for the United States to rebuild its domestic drug manufacturing capacity — and avert a potential health crisis before it happens.
Michael Stumo is CEO of the Coalition for a Prosperous America (CPA). Follow him @michael_stumo.
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