To EUA or Not to EUA? It’s Complicated

Propelled by the COVID-19 pandemic, a new, shortened route to market uptake for some investigational drugs and devices has leaped into public awareness. Companies considering this avenue must recognize and address multiple strategic considerations and potential negative consequences beyond the obvious attraction of early access to patients. Once implemented, careful communication about these products is key to maintaining credibility and confidence.

As this work progresses, several key insights have emerged:

• Public health requires public trust
• Subsets of the population are skeptical
• Lexicon of efficacy and safety matters
• The EUA option may close off opportunities to gather vital trial data
• FDA credibility must be preserved