The issue of whether the Food and Drug Administration approves new medicines fast enough has taken on a central importance in the Trump administration. Earlier this week, during his first address to a joint session of Congress, President Donald Trump called the agency’s drug-approval process “slow and burdensome,” andpromised to “slash the restraints” on the FDA, CNN reports. That echoes pledges he made on the campaign trail, and dovetails with Republicans’ support for deregulation. But some say speeding the FDA’s reviews could let dangerous and ineffective drugs through to the United States market. The FDA, they argue, already moves quickly.
Going by new research, those skeptics may have a point. A brief analysis published today in The New England Journal of Medicine finds that, between 2011 and 2015, the FDA took a median of 306 days to approve new drugs, which was 25 percent faster than the European Medicines Agency in the same time period. The FDA was 74 percent more likely than the European Medicines Agency to approve orphan drugs, which are medicines that treat rare diseases, and for which governments offer incentives to drug companies to develop. (Otherwise, companies would be unwilling to work on these medicines, because they expect few people will buy them.)
The new research follows a more formal study, published in 2012, that looked at data from 2001 to 2010 and concluded the FDA works faster than both the European Medicines Agency and Health Canada.
“The FDA is already making decisions quickly and increasing its regulatory speed shouldn’t be our number-one priority,” Joseph S. Ross, a doctor and researcher at the Yale School of Medicine who worked on both studies, said in a statement.