FDA Approved Hundreds of Drugs Without Evidence They Work. Many Are Dangerous.
3 minute readPublished: Tuesday, June 10, 2025 at 3:47 pm
**FDA Approves Hundreds of Drugs Lacking Sufficient Evidence of Effectiveness**
A recent investigation reveals that the Food and Drug Administration (FDA) has approved hundreds of drugs over the past decade with inadequate evidence of their effectiveness. The investigation, conducted by The Lever and the McGraw Center for Business Journalism, analyzed 429 new drugs approved between 2013 and 2022. The findings indicate that a significant portion of these drugs were approved based on insufficient data, potentially exposing patients to unnecessary risks.
The investigation found that 73% of the approved drugs did not meet the FDA's foundational standards for demonstrating efficacy. Over half of the approvals relied on preliminary data rather than solid evidence of improved patient outcomes. Furthermore, a concerning number of drugs, including many cancer treatments, met only one or none of the four essential criteria for approval.
The investigation highlights the case of Elmiron, a drug for interstitial cystitis, as a prime example. Despite being approved in 1996 with minimal evidence of effectiveness, Elmiron remained on the market for decades, even after subsequent studies failed to prove its efficacy. The drug has been linked to serious side effects, including vision loss and colitis, with hundreds of patients suffering adverse health consequences.
The investigation also points to a broader trend of the FDA loosening its standards for drug approval, particularly for cancer treatments. The reliance on surrogate outcomes, such as tumor shrinkage, rather than clinical outcomes like improved survival, has led to the approval of drugs that may not provide real benefits to patients. This shift has been driven by lobbying efforts from the pharmaceutical industry and patient advocacy groups, who have pressured Congress to relax scientific standards.
The consequences of these practices are significant. Patients are exposed to potentially harmful drugs that may not improve their health, while insurers and taxpayers bear the financial burden of ineffective treatments. The investigation underscores the need for the FDA to prioritize rigorous scientific standards and protect public health.
BNN's Perspective: This investigation raises serious concerns about the FDA's drug approval process. While the agency faces pressure to expedite the approval of new treatments, it must prioritize patient safety and ensure that drugs are proven effective before they are made available to the public. The findings highlight the need for greater transparency and accountability within the FDA to restore public trust in the agency's oversight of the pharmaceutical industry.
Keywords: FDA, drug approval, Elmiron, side effects, vision loss, colitis, cancer drugs, surrogate outcomes, clinical trials, pharmaceutical industry, patient safety, efficacy, unproven drugs, accelerated approval, regulatory standards.