4 December 2017 - New investigational drugs or biologic applications that are not approved by the FDA don’t often see the light of day, with rare exceptions. 

Drugs that are approved, however, do not always meet the same evidentiary standards as one another, leaving those familiar with the industry wondering about the factors that went into the binary “yes/no” decision-making process.

Perhaps the FDA, the federal agency that has access to all the data submitted as part of a new drug application, most of which is not made publicly available, should provide more context around its approval decisions. An approval system that acknowledges varying levels of evidentiary standards would not only communicate important information to stakeholders, such as physicians, patients, insurers, and drug developers, but it may help address the inherent tensions between the desire for access and speed of review on one hand, and proof of safety and efficacy on the other.

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