As expected, FDA approved only 27 new molecular entities (NMEs) in 2013. There was no late-December surge in approvals to bring the tally closer to the near record of 39 innovative new drugs approved in 2012. In addition, the Center for Biologics Evaluation and Research (CBER) approved eight novel products, including innovative influenza vaccines and a number of blood products.
The lower approval total that FDA officials have emphasized in recent weeks fits the averages of the past 10 years and is not a sign of decreased innovation by manufacturers or any slowdown in the agency’s approval process. John Jenkins, director of CDER’s Office of New Drugs, explained at a December meeting that the main reason for the decline in approvals last year is a drop in the number of new drug applications filed with the agency, and not more rejections by FDA. CDER met review time frames for all of the new NMEs, and most of them (89%) were reviewed in the first review cycle.
A report from CDER on the 2013 new drug approvals emphasizes that one-third of the new NMEs are “first-in-class” medicines, and one-third are treatments for rare or orphan diseases. The list includes the first three breakthrough drugs approved by the agency. These drugs and a substantial number of the new approvals benefited from expedited approval under the fast track, priority review, accelerated approval, as well as breakthrough designations—in a number of cases, applications were eligible for more than one expedited approval method. FDA also is proud of the fact that nearly three-quarters of the new drugs were approved first in the United States, compared with foreign countries.
FDA describes its 2013 approval performance as a return to “normal” and not a sign of problems. And it highlights that all its strategies to approve innovative drugs more efficiently help speed patient access to important new medicines. Yet, the lower number of important new therapies coming to market highlights the challenge for FDA and biopharmaceutical companies to devise new methods for improving the success rate in drug-development programs to yield more applications ready for FDA review and approval.