Payers Want Access To US FDA's Pre-Submission Meetings

As sponsors push for more access to physicians, payers hope to be able to gather more pre-approval information about drugs – like they now can with devices – for budgeting and patient access.

Payers want to attend FDA pre-submission meetings with drug sponsors to help better gauge pricing and utilization post-approval. The change, which the agency's device center recently adopted, could be one way for FDA to deal with some industry concerns about off-label communications.

Humana Inc. VP-Federal Affairs Douglas Stoss and others asked during FDA’s two-day public hearing on off-label communications that payers...