Posting Preapproval Access Policies Could Help Prevent ‘Blame And Shame’ Under Right To Try
Executive Summary
Many biopharmas have not publicly posted their policies for evaluating and responding to expanded access requests as required under the 21st Century Cures Act. Putting this information out will help set patient community expectations, but will not viewed by US FDA as off-label promotion, experts say at BIO annual meeting.
You may also be interested in...
Expanded Access Postings Not Promotional, Unless Done In ‘Promotional Context,’ US FDA Says
Updated guidance on expanded access program clarifies that sponsors do not risk enforcement for off-label promotion if they post investigational drug expanded access policies, although that fear already may have subsided.
Expanded Access: US FDA Told To Increase Regulatory Clarity, Early Interactions With Sponsors
Independent assessment finds positive perceptions of expanded access program but calls on agency to do more to correct manufacturer misperceptions about adverse events and clarify when data from expanded access would support labeling extensions.
US FDA's Woodcock: Sponsors Have To Make Right-To-Try Decisions
FDA must still determine internal procedures for receiving annual reports and handling adverse events through the controversial pathway that encourages access to unapproved therapies.