Ophthalmology responds to bevacizumab embargo

December 15, 2007

There are doubts that Genentech is stopping bevacizumab sales to compounding pharmacies purely because of FDA-raised concerns and also by the company's recent history, which includes a series of disturbing actions. However, comments made by a Genentech executive in a personal appearance after the closing session of the Retina Subspecialty Day at the annual meeting of the American Academy of Ophthalmology (AAO) together with assurances provided by Genentech in an earlier meeting between several of its leaders and representatives from the AAO and the American Society of Retina Specialists (ASRS) offered some hope that the impending threat of lack of access to bevacizumab (Avastin) may have a satisfactory resolution.

Key Points

Comments made by a Genentech executive in a personal appearance after the closing session of the Retina Subspecialty Day at the annual meeting of the American Academy of Ophthalmology (AAO) together with assurances provided by Genentech in an earlier meeting between several of its leaders and representatives from the AAO and the American Society of Retina Specialists (ASRS) offered some hope that the impending threat of lack of access to bevacizumab (Avastin) may have a satisfactory resolution.

Concerns, however, continue to be fueled by doubts that Genentech is stopping bevacizumab sales to compounding pharmacies purely because of FDA-raised concerns and also by the company's recent history, which includes a series of disturbing actions.

H. Dunbar Hoskins Jr., MD, executive vice president of the AAO, introduced Susan Desmond-Hellmann, MD, MPH, president, product development, Genentech, at the Retina Subspecialty Day meeting. First, he reviewed information received by the AAO from the FDA on the Genentech situation and summarized the meeting between Genentech officials and leaders from AAO and ASRS. Dr. Hoskins noted that Genentech has said its decision to stop sales of bevacizumab to compounding pharmacies was based partly on concerns raised by the FDA regarding manufacturing of bevacizumab for intraocular use.

"The FDA did note concern about the manipulation of sterile products because of the increased risk of product contamination," Dr. Hoskins said.

"It did not say it had not raised written or verbal concerns about the sterility and repackaging of bevacizumab for intraocular use with Genentech, nor did it say that it had not raised concerns about Genentech sales to compounding pharmacies possibly being off-label promotion," Dr. Hoskins noted.

"We felt these actions by the FDA necessitated a change in our contracts with compounding pharmacies," said Krysta Pellegrino, Genentech spokeswoman told Ophthalmology Times. "We felt if we didn't make that change, there would be a risk of future FDA actions that could potentially risk our ability to manufacture and get drugs to patients. [The FDA] didn't force us to change the distribution of [bevacizumab], but in our interpretation of the inspection, we felt that their actions necessitated that we destroy those lots of [bevacizumab] and change our policies regarding compounding pharmacies."

Prior to Dr. Hoskins' introduction at the AAO meeting, Kirk H. Packo, MD, ASRS emeritus director, reviewed legal issues of off-label medication use and activities of compounding pharmacies and the suitability of alternate methods for continuing use of bevacizumab if sales to compounding pharmacies cease. He said, however, that Genentech has been building a wall of distrust through many actions, beginning in April when it first tried to restrict sales of bevacizumab to compounding pharmacies, and he appealed for an end.

"We recognize Genentech is a business, we respect that, applaud it, and wish Genentech well. We also hope Genentech can continue to provide miraculous drugs and can fulfill its mission that is committed to fulfilling the interests of patients, the medical profession, and Genentech stockholders. [But] Dr. Desmond-Hellmann, please tear down this wall," said Dr. Packo, professor and chairman, Department of Ophthalmology, Rush University Medical Center, Chicago. His comments were met by a standing ovation.

Dr. Packo said that after first announcing bevacizumab sales restrictions, Genentech voiced concerns about carriers obtaining Medicare coverage for bevacizumab before ranibizumab (Lucentis, Genentech) was approved.

In addition, Genentech has opposed a proposal to Medicare to distribute bevacizumab in a sterile syringe for retinal use. Genentech initially indicated that it would provide support for Comparison of Age-Related Macular Degeneration Treatment Trials, a National Eye Institute (NEI)-sponsored prospective study comparing ranibizumab and bevacizumab for treatment of AMD, but then rescinded its support and is selling bevacizumab to the NEI at full retail price. After announcing plans to decrease the time allowed for payment of ranibizumab accounts receivable from 85 to 55 days, Genentech pulled back.

"Following the Oct. 11 letter announcing the sales restriction to compounding pharmacies would begin Nov. 30, Genentech placed the crowning brick in the wall by launching a direct patient letter campaign about the risks of physicians choosing [bevacizumab]," Dr. Packo told Subspecialty Day attendees.