‘To speed Covid-19 treatments, federal officials adopted a new, nimbler regulatory posture. The change was long overdue...
‘In recent decades, for example, the FDA — scarred by episodes like the Vioxx debacle and buoyed by scientists’ increased understanding of the body — has pressed drug makers to demonstrate increasingly rigorous understanding of the mechanisms by which their medicines work. Yet, one might argue that these guidelines reflect either hubris or naivete: The vast majority of safe and effective drugs were approved despite uncertainty about their mechanisms of action. Even today, scientists do not completely understand how acetaminophen works, yet the world is a far healthier place for having this drug...
‘In some high-profile cases during the pandemic, the FDA leaned less on mechanistic proof of effectiveness and more on empirical indicators, such as patient survival rates. For instance, when objective data revealed that the steroid dexamethasone helped severely ill patients survive what might otherwise have been deadly coronavirus infections, the FDA was quick to support the drug’s use, despite scientists having only a speculative understanding of how the steroid works against the disease. To be sure, the FDA must continue to prioritize its mandate to protect patients and clinical trial volunteers. But the pandemic has shown that safety and speed need not be an either-or proposition.’
Read here (Undark, Mar 25, 2021)
