Posted by Michael Wonder on 14 Oct 2017
Nearly one-third of new drugs are no better than older drugs, and some are worse
6 October 2017 - A focus on expediting drug development.
Congress has instructed the FDA to expedite the development and review of promising new drugs through the creation of four programs: accelerated approval, fast-track, breakthrough, and priority review. In a recent Health Affairs article, James D. Chambers and colleagues reported that drugs approved under one or more expedited programs were, on average, associated with larger health gains than those approved under conventional development and review programs. They concluded that the FDA has prioritised the review of drugs that offer the largest clinical advancements.
Chambers and his colleagues should be applauded for using as their metric net health benefit, which is the raison d’être of any pharmaceutical intervention. Although they focused on the FDA’s expedited programs, their research also revealed important information about the benefits of new drugs that is highly patient-relevant, namely, that 20% of expedited drugs and 41% of non-expedited drugs offered zero or negative incremental health gains over older comparators.
