From the American Academy of Ophthalmology

The Academy is urging ophthalmologists to tell the FDA that its proposal on pharmaceutical compounding and beyond-use dates would interfere with the ability to care for patients.

The Food and Drug Administration’s draft guidance, which affects bevacizumab, commercially known as Avastin, outlines how the agency intends to regulate compounding and repackaging of biological products at compounding pharmacies.

Bevacizumab and other anti-VEGF drugs are used to treat a wide variety of diseases and conditions such as age-related macular degeneration, diabetic retinopathy, central retinal vein occlusion and neovascular glaucoma. In many cases, these drugs are used off-label, because there is no FDA approved treatment and the costs of the drugs may not be covered by insurance, making it even more critical that patients have a variety of treatment options.

The draft guidance recognizes ophthalmologists’ use of repackaged biologics to treat diseases such as age-related macular degeneration, but it contains impractical and overly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 believes these dates do not allow adequate time for sterility testing, ordering, shipping and administering to patients before drugs expire, particularly in rural areas.  In addition, the restrictive beyond-use dates would make the use of bevacizumab for the treatment of emergent or urgent conditions, such as neovascular glaucoma, virtually impossible because ophthalmologists will not be able to maintain a supply of the drug on hand to immediately treat patients.

Physicians’ letters to the FDA should include real-life examples of how this proposal would harm patients. The Academy, in a joint grassroots effort with the American Society of Retina Specialists, is providing a template letter (Microsoft Word), a fact sheet explaining the draft guidance (PDF) and instructions for submitting the letter to the FDA (PDF).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.