FDA approved 27 new drugs in 2013

Agency lauds itself on speedy reviews, but others keep pressure on

The annual count of New Molecular Entities (NMEs)—drugs that are not variations on existing active pharmaceutical ingredients—was 27 in 2013, down from 2012’s 39. But as the agency is quick to note, in its Novel New Drugs: 2013 Summary, the number of applications accepted in the year was also down (36 vs. 2012’s 41). “It is noteworthy that FDA cannot expect a continuing upward trend for NME approvals until a sustained increase in the number of applications for NMEs submitted for approval is also demonstrated,” the agency writes. 2012 was an unusually rich year for approvals; 95% of applications were approved.

The 2013 group includes nine “first in class” drugs—drugs for which there is no similar method of action on a disease—and nine drugs for orphan diseases (generally measured as a disease that affects no more than 200,000 patients). Additionally, 10 of the drugs were approved under FDA “fast track” status, by which the agency reviews parts of the application while other parts are still coming in. Overall, 13 of the drugs had some form of expedited review through the agency.

All this has happened while a steady criticism of FDA’s approval process is heard; the complaint arose this fall after several university students across the country contracted a contagious form of meningitis, and FDA and the Centers for Disease Control allowed use of a vaccine, Novartis’ serogroup B vaccine, that has been approved outside the US, but is still going through the FDA review process. Additionally, a recent Wall Street Journal editorial (coauthored by the member of an investment firm with a stake in the company) questioned FDA’s resistance to approving Lemtrada (alemtuzumab) from Sanofi for a form of multiple sclerosis.

FDA's Center for Biologics Evaluation and Research (CBER) also approved an additional 17 vaccines, blood derivative and protein products during the year.