FDA Sets Records in Approving More New Drugs

It was a banner year for the new drug approval business, and now FDA has made it official: The Center for Drug Evaluation and Research (CDER) approved 59 novel drugs and biologics in 2018, surpassing previous high marks and improving on recent gains (a complete list can be found at FDA.gov.). Additional new products approved by the Center for Biologics Evaluation and Research (CBER) further boost the total.

While there’s some variation in the final numbers because analysts define innovative new products differently, it’s clear that industry investment and regulatory support combined to move many important new medicines to market efficiently to provide more treatments for a range of critical conditions. The “class of 2018” has 16 new cancer drugs, including several indicated for genetically defined conditions. There also was a number of new treatments for rare diseases, along with the first cannabidiol-based medicine and the first drug to treat smallpox. Nearly all of the new drugs were approved in one review cycle, and three-fourths were approved first in the United States.

Many of the new approvals benefited from one or more expedited development or review pathway, a trend that has prompted some observers to question whether FDA may be moving some experimental products too quickly to market. However, only 24% of the new drugs were designated as breakthrough therapies, and fast-track review applied to less than half.

To continue the emphasis on advancing innovation in drug development, FDA Commissioner Scott Gottlieb recently announced plans to establish a new office of drug development science at the agency. The aim is to develop and authorize new tools and methods able to reduce the cost and uncertainty in testing and reviewing new medicines. This Office of Drug Evaluation Science will be part of CDER’s Office of New Drugs and will work to implement new methods for clinical outcome assessments, biomedical informatics, and biomarker development. Additional efforts will aim to devise more standardized tools for capturing and formatting safety data to achieve more consistent review of this information.