A

mid ongoing skepticism of the US Food and Drug Administration, a new analysis finds the agency is notably faster at reviewing and approving new medicines than its counterpart in Europe. And the researchers suggest the results, which resemble an earlier comparison, should reassure FDA critics as Congress looks to renew a law that allows the agency to collect industry funds for product reviews.

Of 142 drugs that were approved by both agencies between 2011 and 2015, the median review time at the FDA was 303 days, while the European Medicines Agency took 369 days. For all drugs either one or the other agency approved during that time, the FDA was also quicker — the median review time was 306 days versus 383 days at the EMA, according to the analysis published in The New England Journal of Medicine.

This is a STAT Plus article and is only available to STAT Plus subscribers.
To read the full story, subscribe to STAT Plus or log in to your account.
Good news: your first 30 days are on us.

Leave a Comment

Please enter your name.
Please enter a comment.

  • Numbers are interesting but I have a question. Has anyone looked at the population as a number that benefited per approved drug and were they affordable? In the whole analysis the final numbers are patients who benefited. We can have 500 drugs approved but if they are unaffordable number 500 has no value to anyone.

  • The 66 day differential is a huge drag on profits. Time to wake and smell the greenbacks. One of my first tongue lashings as an entry level Sr. CRA in 1983 was a reminder that every day’s delay in approval cost us $1,000,000. Now with a $5,000,000,000 blockbuster cancer drug that delay translates into almost one billion is lost revenues. Maybe busting up the EU might be a good idea after all.

Recommended Stories

Sign up for our biotech newsletter, The Readout

A guide to what’s new in biotech — delivered straight to your inbox every weekday morning.