FDA Argues That Expedited Approval Does Not Change Requirements
[Thursday, October 10, 2019]
Several expedited programs for market approval created in the last decade has led to products approved in much shorter time and with seemingly lesser burden of proof leading to critics accusing FDA of lowering its standards of approval and allowing riskier drugs to be used on patients. A blog by FDA leaders of the centers for drugs and biologics insists that FDA applies the same statutory standards for safety and efficacy to all new medicines but considers other factors when deciding what to ask the sponsors to provide. It’s a circular answer to the simple question; yes, FDA reduces the amount of data needed to approve an application based on mitigating factors such as rarity and/or seriousness of the disease, and availability of other treatment options, and it is important for FDA to do this to help patients to need these treatments. To say that FDA applies the same statutory requirements to all products may be technically correct but practically it is far from the truth. FDA has approved products with far fewer clinical trials, non-clinical data and other data requirements technically needed for non-expedited products. More products have been approved with data previously considered to be critical, pushed to post-market commitments, in the last 10 years than in the entire history of FDA regulation of new products. And this is not a bad thing on FDA’s part but rather a common sense pragmatic approach. Laws have evolved over the last two decades to tailor approval of new drug and biologic products to the needs of the patients rather than antiquated requirements. Also, the US Congress has given FDA unprecedented resources and freedom to make new regulations and newer requirements, may of them via guidance documents, to implement the expedited programs. The only negative of the approach has been the obvious subjectivity of FDA’s review process. There are a few cases where it seems FDA decisions depended a lot more on a sponsor’s ability to convince FDA teams that their products fits an urgent unmet need criteria to win all kinds of flexibilities, than the data generated. It would serve FDA better to stop apologizing for doing good job and focus on clarifying for all so more products can be approved quickly. Afterall good rules and practices should not be limited only to a few but become a norm for all products.