Food and Drug Administration (FDA) Responds to House Members Regarding Repackaged Biologics; Expresses Concerns Over Extending Beyond Use Dates (BUDs) 
This week, the FDA sent a letter  responding to Rep. Morgan Griffin (R-VA) and the 28 bipartisan House member co-signers of a “Dear Colleague” letter—originally prompted by ASCRS and ophthalmic community advocacy—regarding recent FDA draft guidance on repackaged biologics, such as Avastin. The FDA maintains the 5-day BUD laid out in the draft guidance is scientifically appropriate based on numerous instances during the drug manufacturing and repackaging when sterility could be compromised; and several adverse events reported due to repackaged Avastin. ASCRS, the American Academy of Ophthalmology and other compounding stakeholders dispute FDA’s claim and have noted in comments and testimony before the FDA that sterility testing on Avastin in particular takes two weeks, and following that, the repackaged drug can be safely stored for up to 90 days. The letter from FDA also noted the House members’ concern about patient access to the drug should the guidance be finalized, but did not respond to it. Rep. Griffin has indicated he is considering developing legislation to address this issue. We will keep you updated.