Faster Approval Rates Show Increased FDA-Industry Collaboration
[Thursday, January 9, 2020] For the last few years FDA has been approving more than 40 new drugs each year, a trend that continued in 2019 with the approval of 48 new drugs and biologics. But it is important to look beyond the numbers to fully understand the trend behind these. First let’s look at the numbers. This year’s approvals are similar to previous years where drugs for rare diseases account for about half of all approvals, about two-thirds of approvals used at least one expedited approval program, and about a third of the approvals were for cancer indications. More importantly last year FDA met its PDUFA deadlines 100% of the time, meaning none of the drug approval decisions were delayed by the FDA. On the other hand, several drugs were approved ahead of time. About 90% of the drugs were approved in the first cycle, several with fewer and smaller clinical trials to support approval, and about 70% of the new drugs were approved in the US before any other country. In addition, FDA approved 70 new products that contained new formulations, new uses, or new combinations of previously approved drugs. Although FDA reviewers get the well-deserved credit for doing an excellent job reviewing applications on time, the industry also has become very proficient in using FDA’s pathways to their advantage. Getting at least one of the expedited approval designations for one’s product is the top priority for most developers with requests for all expedited approval pathways at an all-time high. A critical reason for the high first-cycle approval is increased interactions between FDA reviewers and developers who meet often, discuss practically all issues, listen and adjust programs based on each other’s feedback, and troubleshoot problems in a timely manner. Hence by the time the market approval application is submitted, the FDA reviewers are already very familiar with the content and have reached agreements about most of the concerns. FDA also seems to like first-in-class drugs; 20 out of 48 approvals were for first-in-class molecules. Over the years, FDA has developed deeper expertise and smaller dedicated review teams for novel scientific research giving it resources to review newer scientific approaches to treat diseases. So, for developers of first-in-class therapies, FDA has become the go-to agency. These trends are here to stay, so all developers should take these lessons and include them in the game plan, if they haven’t already done that. |
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