Quality control issues like the ones found at Mylan are a leading cause of drug shortages, both at American plants and overseas. Sometimes the F.D.A. shuts down a plant after discovering violations, dramatically reducing a medicine’s supply. Other times, companies with quality control issues simply opt to stop making a drug rather than invest in expensive upgrades to their aging facilities. The current system simply doesn’t reward investments in quality. If a pill is just a pill, it doesn’t matter if it’s made in a state-of-the-art plant or a rusty one.
For example, in 2011, F.D.A. inspectors discovered a host of problems at Ben Venue Laboratories, an Ohio-based drug manufacturer, including poorly maintained equipment that shed particles into the drugs and an inexplicable bucket of urine on the factory floor. Eventually, the company shut its factory down instead of fixing it. The plant happened to be the country’s sole supplier of Doxil, an injectable chemotherapy drug used to treat certain types of cancer. The supply of Doxil dried up. The price of what was left skyrocketed.
In 2016, an explosion at a chemical plant in Eastern China led to a global shortage of an antibiotic combination used intravenously in intensive care. The plant appears to have been the world’s sole supplier of active ingredients needed to make it. Over the past two decades, China has become the world’s top producer of antibiotics, and its aggressive market tactics have driven some American factories out of business. According to the 2018 book “China Rx: Exposing the Risks of America’s Dependence on China for Medicine,” Chinese companies flooded the U.S. market with penicillin so cheap that American companies could not compete. The last American factory making key ingredients for penicillin closed in 2004.
Drug shortages rarely make the newspaper because doctors can usually switch from a preferred drug to another one. But make no mistake: Shortages are costly, and they can be deadly. A study found that a shortage of an injectable cancer drug in 2009 led to higher rates of relapse in children because the substitute didn’t work as well.
Chronic drug shortages of lifesaving medicines that have been around for decades are perhaps the clearest signal that our drug supply is sick. “The system that we have right now is so broken that we need a big shake-up,” Erin Fox, director of drug information at University of Utah Health and one of the nation’s top experts on drug shortages, told me.
Mylan’s executives decided that the company needed a big shake-up, too. Under mounting pressure from bad publicity and the F.D.A., they merged Mylan with a spinoff of Pfizer. Mylan ceased to exist. It was replaced by Viatris, a new entity with global centers in Pittsburgh, Shanghai and Hyderabad. So far, things have turned out all right for Ms. Bresch, who retired with a windfall, and for Mr. Rajiv, who is now president of Viatris. Of course, their factory workers fared worse. In December 2020, the company announced that it was restructuring to cut costs and closing five plants around the world, including the one in Morgantown. A total of 1,431 West Virginians would lose their jobs.
For months, workers hung on to hope that the global pandemic would convince people that the plant had to be saved. They knew that Mr. Trump had directed the F.D.A. to come up with a list of critical drugs, which included everything from aspirin to Zanamivir, an antiviral medicine used to treat the flu, as a first step in figuring out where vital medicines are made. Months later, President Biden ordered a committee to whittle down the list. The report, released in June, painted a grim picture: Of more than 100 supercritical medications, about half are made with ingredients that are not produced in the United States.