FDA approved 22 new drugs in lower-than-average 2016

SILVER SPRING, Md. — The Food and Drug Administration’s Center for Drug Evaluation and Research’s number of new drug approvals came in low in 2016, according to the agency’s year-end review of the new therapies that passed regulatory muster. The number of drugs the FDA approved last year, 22, is less than half of the 45 approved in 2015 and lower than the average of the last 10 years of approvals, which is 29. 

 

However, the agency’s retiring Office of New Drugs director, Dr. John Jenkins, attributes the lower number of approvals to two factors — a smaller pool of applications to target action on (including five drugs with Prescription Drug User Fee Act dates of 2016 that were approved in 2015) and the 14 complete responses (which detail deficiencies in an application) that were sent this year, a number Jenkins said is higher than average. 

 

“While we report on groupings of applications submitted and approved each year, given the expected variation in the quality of the data contained in any particular application it is not surprising that the ratio of approvals to CR letters tends to fluctuate from year-to-year,” Jenkins said in a Jan. 4 letter. “In examining the deficiencies cited in the CR letters issued to novel drugs in 2016 it is notable that the primary deficiency for several of the applications was failure to comply with FDA’s current Good Manufacturing Practice regulations.”

 

Despite the lower number of approvals, The FDA’s Novel Drugs Summary for 2016 notes that the approved drugs have the potential to have a big impact in several areas. Eight of the drugs approved last year were identified as first-in class treatments, including multiple sclerosis drug Zinbryta, and nine (41%) of the novel drugs were approved as treatments for rare diseases that affect fewer than 200,000 Americans. Many of the drugs were approved in one or more of the agency’s expedited categories, with 73% of them receiving Fast Track, Breakthrough, Priority Review and/or Accelerated Approval status. 

 

“More important than the quantity of novel drugs approved in 2016 are the qualities of the new drugs the pharmaceutical industry has developed and the important new roles these drugs are serving to advance medical care,” the agency’s report said.