Take Action to Preserve Access to Avastin
As your Chair of Federal Affairs, I wanted to connect with you on a matter of pressing importance.
As you may know, the FDA’s Draft Guidance on Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (also known as Docket No. FDA-2014-D-1525) has very serious implications for those of us who rely on bevacizumab (or Avastin) to provide sight-saving treatment to patients with age-related macular degeneration (AMD).
The FDA’s proposed beyond use dates (BUDs) for traditional compounders and outsourcing facilities will put bevacizumab out of reach for retina specialists and for our AMD patients who rely on it for effective cost-efficient treatment.
ASRS is urging the FDA to maintain availability of repackaged bevacizumab by setting aside arbitrary proposed BUDs and focusing on the science. Extensive clinical research summarized in peer-reviewed literature has shown that repackaged bevacizumab remains stable, sterile, and efficacious with BUDs longer than those proposed by the FDA when standardized aseptic procedures are followed.
Now it’s your turn to let the FDA know what you think.
Click the links to view my letter to the FDA and to access a customizable FDA letter template, summary of FDA repackaging guidance and talking points, and instructions to assist you in crafting and submitting an FDA comment letter of your own.
If you need further assistance in composing or submitting a letter, contact ASRS Executive Vice President Jill Blim (email@example.com) or ASRS Vice President of Communications Lydia Steck (firstname.lastname@example.org).
Geoff Emerson, MD, PhD