Pre-Approval Information Exchange for Drugs and Medical Devices
New rules make it easier for drug and medical device companies to share information about their products with insurers and formulary committees before full approval. This aims to speed up access to new treatments and devices by allowing insurers to evaluate their value earlier. Citizens may benefit from quicker access to innovative medications and devices that could improve their health and quality of life.
Key points
Companies can now share information about new drugs and devices with insurers earlier, even before full approval.
This information must be clear, include warnings about unapproved status, and detail study results.
The goal is to accelerate reimbursement decisions, potentially leading to faster patient access to new therapies.
The act also mandates a study on how these new rules impact communication and product market entry.
Expired
Citizen Poll