From the American Academy of Ophthalmology

Overly restrictive beyond-use dates for bevacizumab would be problematic for physicians and patients

The Food and Drug Administration is seeking comment on proposed pharmaceutical compounding regulations that would affect bevacizumab, commercially known as Avastin.

The draft guidance outlines how the FDA intends to regulate compounding and repackaging of biological products at compounding pharmacies. It recognizes ophthalmologists’ use of repackaged biologics to treat diseases such as age-related macular degeneration, but it contains impractical and overly restrictive beyond-use dates.

The Academy, in a joint grassroots effort with the American Society of Retina Specialists, is urging members to send individual comment letters to the FDA with real-life examples of how this proposal would interfere with the ability to care for patients. The organizations are providing a template letter (Microsoft Word), a fact sheet explaining the draft guidance (PDF) and instructions for submitting the letter to the FDA (PDF). Contact Sage Bauer in the Academy’s Washington, D.C., office for help drafting a letter. Continue reading on the Eye on Advocacy blog