Quality control issues like those found at Mylan are a major cause of drug shortages, both in US factories and overseas. Sometimes the FDA closes a factory after finding violations, drastically reducing the supply of drugs. Other times, companies with quality control issues simply choose to stop manufacturing a drug rather than invest in expensive upgrades to their aging facilities. The current system simply does not reward investments in quality. If a pill is just a pill, it doesn’t matter whether it’s made in a state-of-the-art or rusty factory.
For example, in 2011, FDA inspectors discovered a host of issues at Ben Venue Laboratories, an Ohio-based drug maker, including poorly maintained equipment that spilled particles into drugs and a bucket of urine. inexplicable on the factory floor. In the end, the company closed its factory instead of repairing it. The factory was the country’s sole supplier of Doxil, an injectable chemotherapy drug used to treat certain types of cancer. The supply of Doxil has dried up. The price of what was left skyrocketed.
In 2016, an explosion at a chemical plant in eastern China caused a global shortage of a combination of antibiotics used intravenously in intensive care. The factory appears to have been the only supplier in the world of active ingredients necessary for its manufacture. Over the past two decades, China has emerged as the world’s largest producer of antibiotics, and its aggressive market tactics have driven some US factories into bankruptcy. According to the 2018 book “China Rx: Exposing the Risks of America’s Dependence on China for Medicine,” Chinese companies flooded the US market with penicillin so cheap that US companies couldn’t compete. The last US plant making key ingredients for penicillin closed in 2004.
Drug shortages rarely make the headlines because doctors can usually switch from one drug of choice to another. But make no mistake: shortages are costly and can be fatal. One study found that a shortage of an injectable cancer drug in 2009 resulted in higher rates of relapse in children because the substitute did not work as well.
The chronic shortages of life-saving drugs that have existed for decades are perhaps the clearest sign that our drug supply is sick. “The system we have right now is so broken that we need a big overhaul,” Erin Fox, director of drug information at the University of Utah Health and one of the the country’s top experts on drug shortages.
Mylan executives decided the company was in need of a big overhaul as well. Under increasing pressure from bad publicity and the FDA, they merged Mylan with a Pfizer spin-off. Mylan has ceased to exist. It has been replaced by Viatris, a new entity with global centers in Pittsburgh, Shanghai and Hyderabad. So far, things have gone well for Ms Bresch, who retired on a windfall, and for Mr Rajiv, who is now president of Viatris. Of course, their factory workers were doing less well. In December 2020, the company announced it was restructuring to cut costs and close five factories around the world, including the one in Morgantown. A total of 1,431 West Virginia would lose their jobs.
For months, workers clung to hope that the global pandemic would convince people that the factory had to be saved. They knew Mr. Trump had asked the FDA to compile an essential drugs list, which included everything from aspirin to Zanamivir, an antiviral drug used to treat the flu, as a first step in determining where life-saving drugs are made. . Months later, President Biden ordered a committee to narrow the list. The report, released in June, paints a grim picture: Of more than 100 supercritical drugs, about half are made with ingredients that are not produced in the United States.