This year the Food and Drug Administration (FDA) released a draft of guidelines that intend to regulate the compounding and repackaging of various biological products. These potential new regulations are particularly important for retina specialists.
Why are these new rules harmful to retina specialists?
Everyday in our practice we rely on medications that are injected into the eye to treat a wide variety of conditions. Macular Degeneration, diabetic retinopathy, retinal vascular occlusions and intraocular inflammation are just some of the diseases in which we use these medications. One of these medications, bevacizumab (avastin) is designated for off-label use for the eye. That means that although retina specialists have used this medication for over 10 years in the treatment of retina disease it has never been tested officially for ocular use.
The issue of off- label use of medications has been under increased scrutiny over the past several years due to incidents of contaminated medications produced by compounding pharmacies that caused harm to patients. The FDA, correctly, has tried to enhance its oversight over compounding pharmacies to protect public health.
What has also happened, unfortunately, is that outside interests (in this case, the pharmaceutical industry) have stepped up their attempts to curtail the use of certain medications in order to maximize profit for their own drugs. For retina specialists, this attack by the pharmaceutical industry revolves around the attempt to restrict access to Avastin.
“In February 2015, the FDA released draft guidance outlining how the agency intends to regulate compounding and repackaging of biological products, including bevacizumab (Avastin), at compounding facilities. The draft guidance will allow for compounding facilities to continue repackaging bevacizumab for ophthalmic use. While the draft guidance recognizes the importance of repackaged products to ophthalmology, it includes some restrictions that would, in effect, eliminate the ability of an ophthalmologist to use bevacizumab. Proposed “beyond use dates” (BUDs) would make it extremely difficult for ophthalmologists to order and store bevacizumab for office use.” (Courtesy of the American Society of Retina Specialists).
Retina specialists across the country have joined together to oppose any restriction on its ability to use Avastin due to its positive effects in treating a wide variety of ocular disorders. We strongly oppose any attempts by outside interests that could harm the care we provide our patients. We will keep you updated on further legislation concerning this serious issue.