A major two-year investigation has exposed deep flaws in the U.S. Food and Drug Administration’s (FDA) drug approval process. From 2013 to 2022, nearly 75% of new drug approvals failed to meet the agency’s own minimum scientific standards — a revelation that is sparking alarm among health professionals, researchers, and patients alike.
- Majority of FDA drug approvals fail basic standards: A two-year investigation revealed that nearly 75% of new drugs approved by the FDA between 2013 and 2022 did not meet the agency’s own four scientific criteria — including the use of control groups, blinded studies, clinical endpoints, and replication — raising serious doubts about their effectiveness.
- Fast-tracked approvals often based on surrogate markers: Many drugs, especially for cancer and Alzheimer’s, were approved using surrogate outcomes like tumor shrinkage or protein levels rather than proven benefits like improved survival or cognitive function. Some, like the Alzheimer’s drug Leqembi, were linked to brain inflammation, hemorrhaging, and even death.
- Database exposes flaws in drug approval system: A new searchable tool rates 429 drugs approved during the past decade based on how many of the FDA’s scientific criteria they met. Drugs scoring 0–2 out of 4 are considered to have insufficient evidence backing their safety and efficacy, despite being widely prescribed.
- Experts urge patients to question prescriptions: Medical professionals advise the public to delay new drugs, research approval histories, and ask doctors whether medications improve real-world outcomes. Fast-tracked drugs, often pushed through under political or industry pressure, may carry serious undisclosed risks.
FDA drug approval system under fire: Investigation reveals hundreds of ineffective and dangerous medications
The joint investigation by The Lever and the McGraw Center for Business Journalism analyzed 429 new drug approvals over a decade, uncovering that the majority were approved based on weak, incomplete, or surrogate evidence. Instead of demonstrating clear improvements in survival, quality of life, or symptom relief, many drugs were fast-tracked based on lab results or imaging changes — surrogate markers that don’t always translate into real-world benefits.
Of particular concern were cancer and Alzheimer’s drugs. Only 2.4% of FDA-approved cancer medications during the study period met all four basic scientific criteria: a control group, trial replication, blinding, and meaningful clinical endpoints.
Alarmingly, 23% of these drugs met none of the four standards. Alzheimer’s drugs, such as Leqembi, were linked to severe brain inflammation and deaths, despite limited evidence of their actual benefit.
One case highlighted in the report is that of Genevieve Lane, who died six weeks after receiving Leqembi during an extension of its clinical trial. She was one of several individuals who suffered severe or fatal side effects from a drug that was rushed to market under the FDA’s Accelerated Approval pathway.
The root of the problem, investigators found, stems from policy shifts that began in the 1980s during the AIDS crisis. Facing pressure from activists and pharmaceutical companies to speed up access to potentially lifesaving drugs, the FDA adopted looser standards and began accepting surrogate outcomes like tumor shrinkage or protein levels as sufficient proof of efficacy.
While well-intentioned, this shift opened the floodgates for drugmakers to win approvals based on incomplete data — often with no follow-up studies to confirm long-term safety or effectiveness.
The investigation also uncovered numerous adverse outcomes from other FDA-approved drugs. For instance, Elmiron, a drug for bladder conditions, was linked to vision loss and dozens of deaths. Despite these outcomes, the drug remained on the market, highlighting a troubling tolerance for risk in the FDA’s current approval system.
In response to these findings, researchers developed a searchable database to help the public check whether their medications were approved based on robust science. The database assigns color-coded ratings — green for drugs meeting all four standards, yellow for those missing one, and red for drugs failing two or more.
To protect their health, experts urge patients to ask critical questions before starting new medications, review drug approval histories, wait for post-market data when possible, avoid unnecessary prescriptions, and work with healthcare providers who question pharmaceutical protocols.
Ultimately, this investigation exposes a broken FDA approval system that prioritizes speed and industry interests over patient safety and scientific integrity — and calls for urgent reforms to restore public trust in one of the nation’s most powerful regulatory agencies.
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