Problems with generic drugs

 When a drug goes off patent, competing companies can make generic versions of the drug. Initially, there’s a fortune to be made, but then brutal competition causes prices to drop. Even though generic medications represent 90 percent of prescriptions that are filled in this country, they’re often so cheap that companies stop making them or cut corners to turn a profit. Now, most generics are produced overseas. In fact, a recent study found that of the top 100 generic drugs that Americans consume, 83 had no American source for the drugs' ingredients. The study also revealed that there's no American source for 97 percent of the most prescribed antivirals, and no American source for 92 percent of the most prescribed antibiotics. Chinese companies flooded the US market with penicillin so cheap that American companies couldn’t compete. The last American factory making key ingredients for penicillin closed in 2004.

One problem with this arrangement is that we have no idea where our drugs are manufactured, or the names of the companies contracted to make it. This information is considered trade secrets in the pharmaceutical industry. Another problem is lack of quality control. With drugs being manufactured overseas (mostly China and India), it’s harder for the FDA to inspect factories. They don’t drop in unannounced like they do here. During the pandemic in 2020, the FDA managed to perform just three foreign inspections. More than a thousand inspections had to be postponed. In 2008 at least 81 people died from a poisoned blood thinner traced back to a Chinese supplier. In another case, Valsartan, a generic drug used to treat high blood pressure was found to contain a probable carcinogen. Another blood-pressure medicine, Lisinopril, was found to vary widely from one batch to the next. An inspection of Ben Venue Laboratories in Ohio revealed that poorly maintained equipment shed particles into the drugs. Major companies have been caught faking and manipulating the data that is supposed to prove that drugs are effective and safe. And so on.

Quality control issues are a leading cause of drug shortages both at American plants and overseas. Sometimes the FDA shuts down a plant after discovering violations. Other times companies with quality control issues stop making a drug rather than investing in expensive upgrades to their facilities. 

So we don't know who makes our generic drugs or whether we can trust them for safety and efficacy. Maybe shortages aren't such a bad thing.

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