The “Accelerated Approval” loophole: 400 FDA-approved drugs in the U.S. would not meet the required standards

11 June 2025

Medications are stored on shelves at a pharmacy on May 12, 2025, in Los Angeles, California.
Eric Thayer / Getty Images

A two-year investigation conducted by journalists Jeanne Lenzer and Shannon Brownlee and published by The Lever raises enormous doubts about the role and integrity of the Food and Drug Administration (FDA), the U.S. agency charged with, among other things, approving the release of new drugs. Hundreds of them would in fact be put on the market without concrete evidence of their real efficacy and sometimes even after their uselessness has been proven. The heart of the problem often lies in the mechanism of so-called “accelerated approvals” (Accelerated Approval Pathway), designed to speed up access to potentially life-saving drugs for serious or rare conditions. However, as the survey reveals, this pathway has become a shortcut that circumvents rigorous efficacy standards. A system that demonstrates how profit always comes first, including health.

The FDA has approved hundreds of drugs not based on concrete, demonstrable clinical outcomes, such as increased survival to a disease or improved quality of life, but rather through an accelerated pathway that relies on indirect indicators or laboratory measurements (so-called “surrogate endpoints”). There are 253 drugs approved through such an accelerated pathway between 2008 and 2021. Of these, as many as 112 (44 percent) had not yet demonstrated direct clinical benefit even eight years after approval, while the remaining 42 were still on the market after 10 years without evidence of efficacy. This means that patients could take expensive and potentially side-effect-prone drugs for years without any real therapeutic benefit. A striking example cited is that of Aduhelm, an Alzheimer's drug that was approved against the advice of its scientific advisory board, only to be later withdrawn due to lack of evidence of efficacy and exorbitant costs.

As reported in the survey, only 3 out of 123 cancer drugs approved between 2013 and 2022 met all four of the FDA's basic science standards. Most (81 percent) were approved based on surrogate endpoints such as tumor shrinkage, with no evidence that they improved survival or quality of life. Copiktra, for example, a drug approved in 2018 for blood cancers, was approved by the FDA on the basis of improved “progression-free survival,” thus with no discernible, linkable effect.

According to Lenzer and ìBrownlee, the “promise” behind the accelerated approvals was that drug companies would have to conduct post-marketing confirmatory studies to demonstrate clinical efficacy - thus, a kind of mass trial. Many companies delayed or never completed these studies, and the FDA was incredibly slow to withdraw ineffective drugs from the market. Between 1992 and 2023, only 10 drugs approved by this route were withdrawn for lack of efficacy. The average time for withdrawal, when this occurs, is six years. Both the procedures in put in place and the appalling delays raise serious questions about the agency's performance and its ability to protect the public once a product is on the market.

Then again, the FDA relies on data provided by the pharmaceutical companies themselves, who conduct their own studies and determine their conclusion. The agency, then, does not conduct independent testing and is not authorized to do so by law. This dependence on the industry it is supposed to regulate creates an endemic conflict of interest and leads the quest for profit to trump scientific rigor. This not only increases health care costs, but also erodes trust in medical science and regulatory institutions.

The implications of this system are serious. Not only are patients being exposed to ineffective drugs, but their pockets and health care systems are being drained. Insurance companies, including federal programs such as Medicare and Medicaid, are forced to reimburse drugs whose usefulness is unproven, turning the paying public into an unwilling funder of what, in effect, become mass clinical trials on unsuspecting people. All this should make us question the possibility of private profit in certain sectors, such as precisely health and health care, where even those who are supposed to protect the citizen turn into useful tools for corporations to accelerate profits.