OPINION:
Americans are fortunate to live in a nation with easy medical care access. In fact, Americans consume an estimated 131 million prescription medications each day. We sometimes take this for granted, particularly when 90% of our daily prescriptions are filled by generic drugs. But there’s a catch. America’s largest generic drug supplier, Aurobindo, is riddled with safety and quality issues, including ties to overseas suppliers with links to China’s military.
The uncomfortable truth is that Aurobindo Pharma has become America’s largest supplier of generic drugs. That in itself should be problematic since Aurobindo’s factories in India have frequently been cited by the Food and Drug Administration (FDA) for unsafe manufacturing practices. But now we’re seeing something more disturbing: Aurobindo relies on suppliers in China that have been sanctioned by the U.S. government for connections to both human rights violations and China’s military.
Americans may be aware of the nation’s heavy dependence on imported pharmaceuticals—particularly for antibiotics and other lifesaving medications. But the problem is so serious that the FDA is allowing some imported medications that come from substandard factories.
Aurobindo offers a prime example. 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.” More recently, Aurobindo was forced to recall a prescription blood thinner deemed “subpotent.”
Aurobindo is unconcerned, however. At least two of the company’s suppliers have a history of producing drugs that fall below FDA standards. In particular, one of Aurobindo’s suppliers in China, Zhejiang Huahai Pharmaceutical Co., supplied a blood pressure medication with a probable carcinogen. FDA inspectors later determined that Zhejiang Huahai ignored evidence that their medication was contaminated.
In addition to such safety issues, Aurobindo is entrenched in supply chains routed through China’s state-owned military complex. At least five of Aurobindo’s suppliers have documented ties to China’s military industries. Washington has already sanctioned the parent companies of four suppliers for connections to China’s military.
Aurobindo’s ties to Beijing run even deeper, though, with 13 of its suppliers controlled by China’s central government. According to Chinese law, these companies are required to support the People’s Liberation Army of China, including its Military Civil Fusion Development Strategy. And 21 of Aurobindo’s suppliers are under provincial government control in China, incentivizing them to follow Beijing’s edicts.
There’s also Aurobindo’s ties to China’s human rights violations, including 15 suppliers linked to Beijing’s genocide against the Uyghur population in Xinjiang, Western China. This puts Aurobindo in violation of the Uyghur Forced Labor Prevention Act (UFLPA) passed by Congress in 2021 to prohibit imports produced through forced labor.
Congress is finally paying attention, however. In a lengthy recent hearing before the House Ways and Means Committee, lawmakers looked at the root causes of America’s ongoing drug shortages. Committee chair Jason Smith (R-MO) noted that many of the roughly 250 medications currently in short supply are made overseas. Mr. Smith added that recalls due to “poor manufacturing quality” are the leading cause of these shortages.
The House Energy and Commerce Committee also held a similar hearing, focusing on the FDA’s poor oversight of overseas manufacturers. In particular, Committee Chair Cathy McMorris Rodgers (R-WA) reported that the FDA frequently holds overseas drugmakers to a lower standard than domestic U.S. producers. In particular, Ms. McMorris cited an instance where a whistleblower in China faced FDA resistance when warning of contamination in a common blood pressure medication.
Both Committees are now urging a legislative solution—the “PILLS Act” introduced last October by Rep. Claudia Tenney (R-NY). Ms. Tenney’s legislation would use production-based tax credits and domestic content requirements to jumpstart domestic U.S. pharmaceutical manufacturing.
Aurobindo’s well-documented safety violations should raise serious red flags in Washington—no less its position as a pass-through entity for sanctioned Chinese companies. Congress must act since the FDA lacks the expertise and willingness to address these problems.
The United States needs to rapidly rebuild its domestic pharmaceutical manufacturing. Rep. Tenney’s PILLS Act should be the first step—incentivizing pharmaceutical companies to shift generic drug production back to the United States. That could save American lives, and Congress should pass the PILLS Act as soon as possible.
• Michael Stumo is CEO of the Coalition for a Prosperous America (CPA). Follow him @michael_stumo.
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