Is the FDA salvageable?

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?