The American health care system is built on the idea that a pill is a pill. Generic drugs are considered equal to and interchangeable with one another — and also with the name brand. This gospel has existed since 1984, when a law known as Hatch-Waxman was passed, allowing companies to make drugs that had gone off patent without having to replicate the same expensive clinical trials. For the most part, all they had to do was prove that the generic was manufactured using good practices and worked in the body in a similar way, within an acceptable range.
Hatch-Waxman has been a stunning success. Americans have grown increasingly comfortable with generic medications, which now represent 90 percent of the prescriptions that are filled in this country. Their widespread use has translated into trillions of dollars in savings. Politicians and experts agree that any hope we have for affordable, universal health care rests on generic drugs.
But in recent years, the generic drug supply has been plagued by problems. Whereas name-brand drugs can be so expensive that people can’t afford them, generics are often so cheap that companies stop making them or cut corners to turn a profit. Competition for market share at rock-bottom price points has led to chronic shortages, unpredictable price-spikes, allegations of illegal price-fixing, and substandard and even dangerous practices. Production of generics has shifted overseas, where it’s harder for the Food and Drug Administration to inspect factories. Major companies have been caught faking and manipulating the data that is supposed to prove that drugs are effective and safe. Probable carcinogens have been discovered in the drug supply. During the pandemic, which caused several countries to ban the export of medical supplies, a new fear has arisen: that faraway factories might one day cut Americans off from their drugs. Dozens of lifesaving medications are made with ingredients no longer manufactured in the United States.
I got interested in the generic drug supply this summer, after I heard that the nation’s largest generic drug factory — the old Mylan plant in Morgantown, W.Va. — was slated to close. Its looming closure flew in the face of promises by Presidents Donald Trump and Joe Biden to encourage more drug production on U.S. soil. The factory workers in Morgantown, aided by activists from Our Revolution, were pushing for the facility to be declared critical infrastructure, essential for national security. “They say they want to shore up domestic production. If that’s true, you can’t have a better scenario,” Joe Gouzd, the president of the factory’s union, United Steelworkers Local 8-957, told me. “This is a turnkey facility.”