# Understanding the FACTS Act

This bill makes it easier for the FDA to approve new drugs, vaccines, and medical devices by allowing data collected during health emergencies to count toward final approval. Normally, when a company wants to get a new medicine or device approved, they have to run lengthy studies to prove it's safe and effective. But during emergencies like pandemics, the FDA can issue "emergency use authorizations" that let products be used before all that testing is complete. This bill says that the information gathered while products are being used under emergency authorization can now be used as part of the regular approval process, rather than starting from scratch with new studies.

The practical effect is that products used during emergencies could move toward permanent approval faster. For example, if a vaccine gets emergency authorization and is used on millions of people, all the safety and effectiveness data collected from those real-world uses can now count toward the FDA's final decision to fully approve it. The bill also clarifies that medical devices tested during emergencies can keep their categorization when they apply for regular approval. This could speed up how quickly emergency products become permanently available.

However, the bill includes important safeguards. It says the FDA's normal approval standards don't change—companies still have to prove their products are safe and effective. The bill also excludes any data that was previously found to be inadequate or insufficient. So while this streamlines the process, it doesn't lower the bar for what counts as acceptable evidence. The goal is to reduce redundant testing and paperwork when companies already have real-world data from emergency use, potentially getting beneficial products to patients faster without compromising safety requirements.

FACTS Act

Burgess, Michael C.

FDA Advancing Collection of Transformative Science Act or the FACTS Act This bill establishes that certain data and determinations from a request for emergency use authorization for a drug, biological product, or medical device may apply to later regulatory procedures for that product. Specifically, data generated to support a request for emergency use authorization may constitute valid scientific evidence to be considered for various later submissions to the Food and Drug Administration (FDA), including a request for market approval. Also, when granting emergency use authorization for a medical device, if the FDA determines that the device performs certain simple low-risk examinations or procedures, that determination shall apply to certain other regulatory submissions unless additional information contradicts that determination.