Florida seniors at risk from unsafe prescription drugs
Critical medicines have been in the news lately, particularly with the nation facing an import-shortage of the antibiotic Amoxicillin. As Florida Sen. Marco Rubio recently observed, this “reliance on foreign nations for critical goods is dangerous and unsustainable.”
Rubio is urging fellow lawmakers to bring pharmaceutical manufacturing back to the United States —something that should matter in particular to Florida’s 4.2 million retirees. Roughly 90 percent of Florida seniors take prescription medications each day, which puts them on the front lines of a new health crisis — a growing wave of unsafe medicines manufactured overseas.
All of this is a consequence of America’s heavy dependence on drug makers in India and China that repeatedly violate Food and Drug Administration (FDA) safety regulations. Florida lawmakers should look carefully at the problem to help ensure the safety of the state’s elderly residents.
Most Americans rely on generic medications to fill their prescription needs. But the drug manufacturers that supply U.S. consumers, including Aurobindo Pharma — the nation’s largest supplier of generic drugs — are routinely flagged by the FDA for unsafe manufacturing practices in overseas factories. Despite this — and more than a decade of contamination issues, product recalls, and safety concerns — Aurobindo continues to supply medications to Florida and the rest of the U.S.
Earlier this year, the FDA issued a warning letter to Aurobindo citing “significant deviations” from safe manufacturing practices for pharmaceutical ingredients. This isn’t surprising since the FDA has experienced trouble with Aurobindo since 2011. In 2019, for example, 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 for being “subpotent.”
Aurobindo isn’t the only overseas drug manufacturer with a track record of safety problems. Pharmaceutical manufacturers in China and India routinely receive "warning letters" from the FDA for 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.” However, the FDA has not made in-person inspections in 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 drug manufacturers for lifesaving medicines? It’s the result of heavily subsidized overseas drug producers artificially lowering their prices to put 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 medicines are also produced overseas.
Despite this, the FDA is still allowing substandard and unsafe generic medications to enter the U.S. And the numbers involved are staggering. In 2019 alone, the United States imported $127.6 billion worth of pharmaceutical products.
The FDA must conduct in-person inspections of drug makers 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 unsafe medicines.
Florida residents overwhelmingly agree. A national 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 of voters say they oppose importing any generic drugs from China. That’s sensible, since 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 nation no longer manufactures penicillin — and has virtually no capacity to produce antibiotics, among many other lifesaving medicines.
All of this has left seniors — particularly in Florida — deeply vulnerable. Since Florida is home to one of America’s largest senior populations, it can help to lead by insisting on safe drug imports. It’s past time for the United States to rebuild its domestic drug-making 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.
This article originally appeared on Fort Myers News-Press: Florida seniors at risk from unsafe prescription drugs
