AAO airs concerns about beyond-use dates for repackaged Avastin

The American Academy of Ophthalmology has provided comments to the FDA expressing its concern that beyond-use dates for repackaged Avastin may limit the drug’s availability for the treatment of age-related macular degeneration.

The beyond-use dates (BUDs) were included in one of five draft guidance documents issued by the FDA in February to clarify provisions of the Drug Quality and Security Act and Compounding Quality Act. The laws were passed in 2013 in the wake of infectious outbreaks traced to steroids and repackaged Avastin provided at compounding pharmacies.

In the letter signed by George Williams, MD, AAO secretary for federal affairs, which was provided as comment on “Draft Guidance for Industry Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application,” the AAO expressed concern that the BUDs will make Avastin (bevacizumab, Genentech) unavailable to ophthalmologists and their patients.

“While the Academy applauds the Agency’s efforts to ensure the safety of these products, there is significant concern among Academy members and patients choosing bevacizumab as their treatment of choice that the recommended BUDs will effectively eliminate access to the drug,” the letter said. “Suggested BUDs of 4 hours, 24 hours, and 5 days are insufficient to ensure access to bevacizumab for ophthalmology patients. The Academy feels the Agency did not present evidence in the draft guidance showing that the short intervals are necessary for patient safety, drug efficacy or that a longer BUD is inappropriate.”

The letter stated that a 5-day BUD for Avastin is insufficient because sterility testing for each lot of the drug requires at least 14 days.

“Even a 5-day BUD is not long enough to accommodate this critical testing, as the BUD would run out before test results are returned from a third party laboratory,” the letter said. “A second issue with the proposed BUDs involves shipment from the facilities to the practice placing the order. No ophthalmology practice is able to receive a shipment of repackaged bevacizumab in less than 24 to 36 hours.”

The letter also stated that the BUDs will increase administrative burdens on practices, increase costs and have an adverse impact on rural practices.

The letter recommended a BUD of 90 days for repackaged bevacizumab.

“This is the minimum amount of time necessary to ensure necessary microbiologic testing be completed, allow reasonable shipping time, and permit sufficient refrigerated shelf life to have patient access in clinical settings,” the letter said. “The Academy feels that current clinical evidence shows stability and sterility of repackaged bevacizumab, and thus safety and effectiveness, is maintained for longer than 5 days given the widespread clinical use of the drug with apparent safety and effectiveness.” - by Matt Hasson

Reference:

Comment from American Academy of Ophthalmology. http://www.regulations.gov/#!documentDetail;D=FDA-2014-D-1525-0207