I have been pondering how to salvage the FDA. Maryanne Demasi asks the same question
Excerpt below. BTW, it would save the govt and citizens a great deal of downstream money if user fees were ended or did not go to FDA, and Congress fully funded FDA instead
The FDA has been rubber-stamping drugs that barely work while Big Pharma cashes in. Now, with Marty Makary at the helm, can he fix a broken system?
Dr Marty Makary—now confirmed as FDA Commissioner—inherits an agency that routinely approves drugs with questionable benefits.
At Makary’s confirmation hearing on March 6th, senators repeatedly hailed the FDA as the “gold standard” of drug regulation—a phrase meant to reassure the public that approved drugs are significantly effective.
But this claim is an illusion.
In 2013, Jonathan J. Darrow, a Harvard legal scholar and expert in drug regulation, published a scathing analysis in the Washington and Lee Law Review, exposing the reality behind this phrase.
Darrow’s paper, Pharmaceutical Efficacy: The Illusory Legal Standard, meticulously details how the FDA’s approval process does not require drugs to be meaningfully effective—only that they show some effect, no matter how trivial.
Since then, the problem has only worsened.
Makary has spent years criticising medical waste and corporate influence in healthcare. But now, as the new FDA Commissioner, can he reform an institution this compromised?
The “gold standard” that fails the public
The phrase “gold standard” suggests uncompromising scientific scrutiny. However, under U.S. law, there is no specific level of efficacy required for a new drug to be approved.
The FDA’s legal framework, Title 21 of the U.S. Code, demands only “substantial evidence” of benefit, without defining what “substantial” actually means.
Darrow explains: “The standard is almost entirely illusory because it leaves to the drug sponsor the ability to specify any non-zero level of efficacy.”