Academy and Retinal Specialists Meet with Genentech
The American Academy of Ophthalmology sent me this letter yesterday. Genentech has agreed to postpone its sales embargo of Avastin until January 1, 2008.
The third point below, about “Seek advanced comment,” was necessary because Genentech sent a letter to AMD patients stating that Avastin was not approved for the treatment of AMD. I was surprised when a patient called me to ask about this letter and wondered how Genentech could so easily contact patients directly? Under HIPAA privacy rules, if I want to review my own patients’ charts for research, I have to undergo a prolonged approval process with the Human Subjects Review Committee to ensure patient confidentiality.
The most significant part of this letter to me though was the paragraph that followed the bullets stating that, “Genentech reaffirmed its position that its actions were a result of communications from the FDA” and “that it would rescind its decision if the company gets sufficient clearance to do so from the FDA.” So the FDA told Genentech or at least suggested to them that they may want to restrict Avastin sales? And if the FDA gives its clearance, then Genentech will reverse its decision?
Good. I would like retinal specialists and patients to have a choice between Avastin and Lucentis. So I’m going to write my congressmen to urge the FDA to give Genentech “sufficient clearance” to continue sales of Avastin to compounding pharmacies.
October 29, 2007
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, MDASRS, President
American Academy of Ophthalmology
655 Beach Street San Francisco, CA 94109-1336
Tel. 866.561.8558 Fax 415.561.8533 www.aao.org
The third point below, about “Seek advanced comment,” was necessary because Genentech sent a letter to AMD patients stating that Avastin was not approved for the treatment of AMD. I was surprised when a patient called me to ask about this letter and wondered how Genentech could so easily contact patients directly? Under HIPAA privacy rules, if I want to review my own patients’ charts for research, I have to undergo a prolonged approval process with the Human Subjects Review Committee to ensure patient confidentiality.
The most significant part of this letter to me though was the paragraph that followed the bullets stating that, “Genentech reaffirmed its position that its actions were a result of communications from the FDA” and “that it would rescind its decision if the company gets sufficient clearance to do so from the FDA.” So the FDA told Genentech or at least suggested to them that they may want to restrict Avastin sales? And if the FDA gives its clearance, then Genentech will reverse its decision?
Good. I would like retinal specialists and patients to have a choice between Avastin and Lucentis. So I’m going to write my congressmen to urge the FDA to give Genentech “sufficient clearance” to continue sales of Avastin to compounding pharmacies.
October 29, 2007
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, MDASRS, President
American Academy of Ophthalmology
655 Beach Street San Francisco, CA 94109-1336
Tel. 866.561.8558 Fax 415.561.8533 www.aao.org
posted by James C. Folk, M.D. at 10:46 AM
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