FDA’s Drug Approvals on Track to Double Over Last Year’s Pace

A recent Bloomberg article provided commentary regarding the rate at which the FDA is approving drugs. So far this year, thirty-four new drugs have been approved, the decision on at least nine of which came more than 20 days ahead of the FDA’s scheduled action date. The agency’s actions aren’t just the product of the new administration; the accelerated approvals can be traced back to legislation passed in 2012 that reduced review times.

The speed to market has been reflected in rising drug stocks as well. The Nasdaq Biotechnology Index is up 29% since the start of the year, and outpacing other indices. Samual Islay, managing partner of OrbiMed Advisors said, “We are more ready to give the benefit of the doubt toward approval rather than disapproval. There’s not only a higher probability of approval, but of a broader, more expansive label.”