(Note: this information was issued as an e-mail alert, sent to all Academy members)
Last Friday, the leadership of the Academy and the American Society of Retina Specialists (ASRS) met with three of Genentech’s top leaders: the company’s chairman/CEO, president and chief medical officer. We had a frank and open discussion about Genentech’s decision to stop sales of Avastin® to compounding pharmacies and impressed upon them our deep concern for its impact on patients’ access to this treatment option. We are encouraged by the meeting results and hope our optimism will be justified by future actions.
Genentech has agreed to:
- Delay the Avastin sales embargo to compounding pharmacies until Jan. 1, 2008, which allows us more time to help our members find work-around solutions;
- Not impede physicians or other legal agents (e.g., group purchasing agents) from ordering Avastin or using compounding pharmacies after the embargo is in place;
- Seek advance comment from the Academy and ASRS on any direct-to-patient or -physician communications on Avastin versus Lucentis®;
- Work with appropriate parties to make anti-VEGF therapy available for eligible low-income or under-insured patients;
- Ensure that an anti-VEGF agent (Avastin or Lucentis) 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; and
- Send Susan Desmond-Hellmann, Genentech’s president of product development, to the Academy’s Retina Subspecialty Day program and the upcoming ASRS meetings, where she will discuss this issue with our membership.
Genentech reaffirmed its position that its actions were a result of communications from the FDA. The company has agreed to share the specifics of this information, which we in turn will share with our members. More importantly, however, Genentech said that it would rescind its decision if the company gets sufficient clearance to do so from the FDA.
On our part, the Academy and ASRS will continue all efforts to protect the physicians’ right and ability to use off-label drugs.
While it is hard to overlook Genentech’s initial decision, we cannot ignore the fact that the company has given ophthalmologists and patients a breakthrough treatment for macular degeneration and other eye diseases. We trust and will continue to seek verification that Genentech is committed to addressing our concerns in a reasonable and timely manner.
Sincerely,
C. Pat Wilkinson, MD
Academy President
H. Dunbar Hoskins, Jr., MD
Academy Executive Vice President
Julia Haller, MD
ASRS President