People’s Pharmacy | Not all generic drugs are equal

Do you take any medications? Nearly half of all Americans take prescription drugs (Demography, Oct. 1, 2023). Make that 85 percent of seniors (NCHS Data Brief, May 2019). Such medicines are a key component of health care.

The vast majority of these prescriptions–more than 90 percent–are filled with generic drugs. The Food and Drug Administration (FDA) maintains, as it has consistently, that “FDA-approved generic drugs have the same high quality, strength, purity and stability as brand-name drugs.”

The authors of a recent perspective titled their article: “Substandard Generic Drugs–Threats to Patient Safety and National Security” (New England Journal of Medicine, March 18, 2026). They point out that the overwhelming majority of generic medications are now made outside the United States in an effort to lower costs.

The authors list a number of problems with this arrangement. Some foreign countries have lax regulatory controls when it comes to drug manufacturing. The FDA is not able to monitor every manufacturer on a regular basis. In fact, they note, “In 2022, the Government Accountability Office reported that 61% of foreign plants had not been inspected by the FDA in the preceding 5 years.”

Sometimes FDA inspections find worrisome problems. Quality control documents are occasionally altered or destroyed. Drug ingredients may be stored in questionable conditions. High levels of nitrosamines (cancer-causing chemicals) have been detected in several commonly prescribed generic medicines made abroad.

The FDA’s approach seems to be, “no harm, no foul.” But people have been harmed by poor quality generic drugs. Some have described their experience to The People’s Pharmacy.

One person wrote: “My husband was hospitalized for acute kidney transplant rejection. In the hospital, the doctor was very concerned to learn that he had switched a few months earlier to the generic form of tacrolimus. Before that, he had been on Prograf for years with no rejection problems.

“The doctor said that they had at least two other patients who were treated for rejection after switching to the generic. We couldn’t believe it, since he asked the nephrologist if it was OK before he switched.

“Unfortunately, my husband’s transplant couldn’t be saved. He is currently back on dialysis waiting for another kidney transplant.”

Anti-rejection drugs are a particular concern. However, we have also heard from people who have had trouble with generic antidepressants. Here is one person’s story: “When my insurance took Wellbutrin off their formulary list, my co-pay went through the roof. I began taking generic buproprion. Soon I experienced severe depression. My doctor now writes my prescriptions as NBO (‘name brand only’).”

The authors of the perspective in the New England Journal of Medicine have several recommendations to improve drug safety. The first is to acknowledge that a problem exists. Since the FDA does not test drugs itself, it cannot claim with confidence that all approved generic drugs meet quality standards.

The agency could encourage testing by accredited third-party laboratories. Results of this testing could be used to help the FDA prioritize its inspections.

They also recommend incentives to bring drug manufacturing back to the US and sharing quality scores with the public. With testing data available, both patients and government buyers could choose high quality generic medications rather than going for the lowest cost. This might save lives.

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Joe Graedon is a pharmacologist. Teresa Graedon holds a doctorate in medical anthropology and is a nutrition expert. Their syndicated radio show can be heard on public radio. In their column, Joe and Teresa Graedon answer letters from readers. Write to them in care of this newspaper or e-mail them via their Web site: www.PeoplesPharmacy.com.

This story was originally published April 3, 2026 at 4:00 AM with the headline "People’s Pharmacy | Not all generic drugs are equal."