U.S. FDA under fire for approving hundreds of drugs without proof they work or are safe

A damning investigation has revealed that the U.S. Food and Drug Administration (FDA) approved hundreds of drugs between 2013 and 2022 without sufficient evidence they work—and in some cases, despite evidence they may cause serious harm.

Medical journalists Jeanne Lenzer and Shannon Brownlee reviewed over 400 drug approvals and found that 73% failed to meet all four of the FDA’s basic scientific standards for demonstrating effectiveness. Shockingly, 40 drugs met none of the criteria, which include control groups, replicated trials, participant blinding, and clinically meaningful endpoints.

The investigation highlights a pattern of regulatory failure, with many drugs fast-tracked through approval on preliminary or surrogate data, like tumour shrinkage, rather than actual benefits such as extended survival or symptom relief. Some follow-up trials were never completed; others revealed the drugs were ineffective or dangerous, yet the products remained on the market. High-profile examples include Copiktra, which was later linked to earlier death in cancer patients, and Elmiron, which caused vision loss in some users but is still prescribed today.

Critics say the FDA has become too reliant on industry funding and political pressure, eroding its role as a gatekeeper for public health. Experts warn the agency’s weakened standards have left doctors and patients misled by drug labels that suggest a level of certainty and safety that often doesn’t exist.

As concerns grow over the cost in lives and billions of taxpayer dollars spent on questionable medications, calls for urgent regulatory reform are mounting, with some experts arguing the FDA now functions less as a watchdog and more as a rubber stamp for pharmaceutical companies.

Image credit: Myriam Zilles