With 2016 in the rearview, here are four stats detailing how the FDA fared last year in enforcing regulations and approving new drugs.
The FDA approved 22 new drugs — down from 45 in 2015, a six-year low. Some of the year’s most closely watched approvals included Merck’s HCV drug Zepatier, Genentech’s Tecentriq for the most common form of bladder cancer, and Sarepta Therapeutics’ Exondys 51 — the first treatment for Duchenne muscular dystrophy.
The FDA’s Office of Prescription Drug Promotion issued 11 enforcement letters in 2016, up slightly from 9 in 2015 and in 2014. Of those 11 enforcement letters, three warning letters were issued last year, which are typically reserved for more serious marketing infractions.
Nine drugs with a Breakthrough Therapy designation were approved through the FDA’s new drug application or biologics license application pathways — down from 12 in 2015. Gilead Sciences’ Epclusa, an HCV drug that treats all six major genotypes, headlined that list along with Genentech’s leukemia drug Venclexta.
The FDA issued two Priority Review vouchers in 2016, down from five last year. PaxVax received the first for its cholera vaccine, Vaxchora, while Sarepta Therapeutics received one for Exondys 51.
Sources: FDA.gov, EvercoreISI