Which factor is typically not a reason for a drug to receive "fast track designation"?

The typical criteria for a drug to receive "fast track designation" are primarily based on its potential to address unmet medical needs, provide significant benefits relative to existing therapies, and achieve more effective treatment outcomes. These designations are meant to expedite the development and review process for drugs that can potentially improve patient care, particularly in areas where no adequate therapies exist or where substantial advancements can be made.

The high cost of drug development, however, is not a recognized factor for receiving fast track designation. While cost considerations can impact the overall market viability of a drug, they do not align with the FDA's specific criteria for this designation. The focus of fast track designation is on the drug's clinical benefits and its potential impact on patients and public health, rather than the financial aspects of its development. Thus, high drug development costs do not typically influence the designation process.