President Donald Trump's nominee to head the Food and Drug Administration was before Congress this week. Scott Gottlieb wants a quicker approval process for new drugs, but a new study said the FDA already works faster than its peer agency in Europe.
Speaking at a confirmation hearing in Washington, Scott Gottlieb, a Wesleyan graduate and Westport resident, said when the FDA approves a new drug, it shouldn't have to choose between safety and speed.
"We can have better efficiency and better safety, and also remain faithful to FDA's gold standard for regulatory conduct," Gottlieb said.
And 2017 probably will be a year when, at least when it comes to drug approvals, Washington is focused on efficiency.
That's because a law called the Prescription Drug User Fee Act is up for reauthorization. It sets time limits on FDA reviews of new drug applications.
So just how long does a drug approval take? Nicholas Downing, a resident physician at Brigham and Women's hospital, writes about that in the latest edition of The New England Journal of Medicine.
"In our prior work, and in this work, we have found that the Food and Drug Administration consistently conducts reviews of applications for new drugs approximately two months faster than the European regulator," Downing said.
Downing said for the FDA, total review time for approved drugs is about 306 days -- compared to 383 for its peer agency in Europe, The European Medicines Agency.
The work builds an earlier study by Downing and a physician at Yale, which looked at FDA approval times from 2001 through 2010.
But Downing said speed isn't everything. There's safety, too. And he hopes his study inspires more research in an area he said needs much more attention -- the relationship between the speed of drug reviews and the safety of products after their approval.
