The FDA Autobahn for New Drugs

The FDA is approving new drugs faster and with less evidence of their safety and effectiveness, according to a new JAMA study spanning the past 4 decades, NPR Shots reports.
 
2 or more pivotal clinical trials used to be the norm for approval; but almost half of the new drugs studied were based on just 1. Reliance on “surrogate measures”—like measuring tumor shrinkage instead of improvements in survival post-treatment—has also grown.
 
Approval turnaround has shrunk from 2.8 years in the late 1980s to 10.1 months in 2018.

Another concern: Drugmakers paid $908 million in review fees in 2018, making some experts worry about industry sway trumping patient benefits.
 
Are the fast-tracked drugs worthwhile? Some more than others, says Joshua Sharfstein, former FDA Principal Deputy Commissioner and a vice dean at the Johns Hopkins Bloomberg School of Public Health.
 
In an accompanying JAMA editorial, he lays out some ideas for reform.

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