South San Francisco, CA-Genentech has delayed a previously announced embargo of bevacizumab (Avastin) sales to compounding pharmacies, moving the effective date from Nov. 30 to Jan. 1.
South San Francisco, CA-Genentech has delayed a previously announced embargo of bevacizumab (Avastin) sales to compounding pharmacies, moving the effective date from Nov. 30 to Jan. 1. A representative of the company will attend the upcoming annual meeting of the American Academy of Ophthalmology (AAO) to answer questions ophthalmologists might have related to the issue.
In a statement issued Oct. 29, leaders of the AAO and the American Society of Retina Specialists (ASRS) reiterated their concern that an embargo would negatively affect patient access to off-label treatment using the drug for wet age-related macular degeneration, diabetic retinopathy, macular edema, and other conditions. The delay, however, will allow the organizations “more time to help our members find work-around solutions,” they said.
Bevacizumab is approved by the FDA only for oncology-related indications. Ophthalmologists who use it to treat eye disorders rely on compounding pharmacies to divide vials of the drug into smaller doses.
AAO President C. Pat Wilkinson, MD, AAO Executive Vice President H. Dunbar Hoskins Jr., MD, and ASRS President Julia Haller, MD, wrote that they were “encouraged” by an Oct. 26 meeting with Genentech’s chairman/chief executive officer, president, and chief medical officer. In that meeting, according to statement, Genentech also agreed not to impede physicians and group purchasing agents from ordering bevacizumab or using compounding pharmacies after the embargo is in effect, and to “ensure that an anti-[vascular endothelial growth factor] agent can be made rapidly available for patients with time-critical needs in a way that minimizes in a legally appropriate manner the financial risk to the physician.”
The company also agreed to send Susan Desmond-Hellmann, MD, MPH, its president of product development, to the Retina Subspecialty Day program at the upcoming AAO annual meeting and to upcoming ASRS meetings, to discuss the issue with members. She will speak at 5:15 p.m. Nov. 10 in the convention center auditorium immediately following the Retina Subspecialty Day program.
In an open letter posted on its Web site Oct. 29, Genentech said that its decision to embargo sales of bevacizumab to compounding pharmacies followed concerns raised by the FDA “related to the sterility and repackaging of the drug for ocular use in a warning letter to a compounding pharmacy.” FDA inspectors subsequently expressed concern that the drug continues to be used for off-label indications, according to Genentech. “To resolve the concerns raised by the FDA, we destroyed four batches of [bevacizumab] deemed unsuitable for use in the eye due to a higher visual inspection standard. (These lots would have been entirely suitable for its approved use as an intravenous cancer medication.) The action resulted in the loss of more than 350,000 vials of [bevacizumab] with a market value of more than $200 million. The implication of this event was that future supplies of [bevacizumab] would likewise be at risk of having to be destroyed. In our judgment, these FDA actions-and the potential for future similar actions-necessitated a change in our policy toward compounding pharmacies.”
The company noted that it will reinstate its supply of bevacizumab to compounding pharmacies if the FDA grants legal and regulatory authorization to do so.