DIA: Driving Insights to Action

Time to Press the Pause Button on Speedy Drug Approvals?

March 23, 2020

New drugs are getting through the FDA approval process faster. According to a study published in January 2020, the review time for standard drug applications has decreased from more than 36 months in 1983 to approximately ten months in 2018. “It can be a good thing for drugs to reach the market faster, if those drugs offer large benefits. But often drugs offer only very small benefits over existing treatments,” says Dr. Jonathan Darrow, pharmaceutical policy expert and Assistant Professor at Harvard Medical School in Boston. “The system we have is a patchwork of various policies,” explains Dr. Joshua Sharfstein, former FDA Principal Deputy Commissioner, now Vice Dean and Professor at Johns Hopkins Bloomberg School of Public Health in Baltimore. “We should take a step back and say, ‘Are there ways to align incentives more so we have more money to spend for treatments that make a huge difference for people who need them?’”