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Genentech has resolved its dispute with American ophthalmologists over the off-label use of its anti-VEGF drug Avastin, and will now allow physicians to purchase the drug directly from authorized wholesale distributors.
Genentech has resolved its dispute with American ophthalmologists over the off-label use of its anti-VEGF drug, Avastin and will now allow physicians to purchase the drug directly from authorized wholesale distributors.
Genentech had planned to restrict sales of Avastin to independent compounding pharmacies, which divide vials of the drug into smaller portions for off-label use by ophthalmologists. However, there was uproar when this news reached doctors as they believed it was an attempt to force them to use the approved, but far more expensive drug, Lucentis. A single dose of Avastin costs around $45 dollars, whereas Lucentis can cost up to $2000 per injection.
Genentech claimed that by continuing to supply Avastin to compounding pharmacies, it was putting its manufacturing operation at risk as the FDA had raised concerns. Krysta Pellegrino, a Genentech spokesperson said, "We felt that if we didn't make a change [in contracts with compounding pharmacies], there would be a risk of future FDA actions that could potentially risk our ability to manufacture and get drugs to patients."
While the FDA did note that it was worried about the "manipulation of sterile products" due to increased risk of contamination, it also pointed out that to date, the adverse reactions reported following use of Avastin for ocular indications were consistent with those of Lucentis.
Responding to an e-mail enquiry from the American Academy of Ophthalmology (AAO), the FDA stated that it did not ask Genentech to stop distributing bevacizumab to compounding pharmacies and that it had not taken action to limit its off-label use.
However, the company has now agreed, in association with the AAO and the American Society of Retina Specialists (ASRS), on a protocol that will allow physicians to purchase the drug directly from authorized wholesale distributors. The distributor can then ship the drug to the destination of the physicians choice, including hospital pharmacies, compounding pharmacies and the physicians own office.
In a message to their members the AAO and the ASRS said they believed the plan "addressed the needs of most of their members." However, they also reminded their members that regulations on the matters vary from state to state, so recommend that physicians check with their legal advisors when considering this new option.
The message also addressed the ongoing concerns regarding the price of Lucentis, "Genentech also remains committed to ensuring that eligible patients have access to Lucentis regardless of their ability to pay. Therefore, Genentech, the Academy and ASRS are working together to develop additional programs that will more efficiently facilitate and expedite patient access and physician reimbursement for Lucentis."