US ophthalmologists plead with drug regulator not to restrict access to Avastin

Ophthalmologists in the United States have criticized the Food and Drug Administration for issuing guidance that would potentially restrict the use of bevacizumab (Avastin) for eye conditions. Some critics have suggested that the agency’s advisory committee has conflicts of interest.

Bevacizumab is approved for various cancers and is also repackaged into smaller doses in compounding pharmacies and used “off label” for eye conditions, the FDA said. However, after outbreaks of endophthalmitis from contaminated repackaged bevacizumab the FDA sought to regulate compounding pharmacies. In draft proposals it said that there would be a maximum limit of five days allowed between splitting up the drug in a pharmacy and it being used.

George Williams, secretary for federal affairs at the American Academy of Ophthalmologists and professor of ophthalmology at Associated Retinal Consultants in Michigan, told The BMJ, “If this BUD [beyond use date] is implemented the logistical implications will greatly impede the use of Avastin …