Avastin update: Still seeking answers

In yesterday’s post, I parsed Genentech’s open letter regarding its decision to stop selling Avastin to compounding pharmacies. Genentech implies that the FDA is forcing the company to crack down on Avastin distribution. Once I wrote that, I was alerted to an email that FDA sent to the American Academy of Ophthalmology on October 16, and which was posted on the AAO site. Here it is:

From: Kelly, Christopher
Sent: Tuesday, October 16, 2007 1:00 PM
To: [AAO Representative] Subject: FDA statement on Avastin

Unlike Lucentis (ranibizumab for injection), Avastin (bevacizumab) is not approved for ophthalmic use. However, the Food and Drug Administration (FDA) did not ask Genentech to stop distributing Avastin to compounding pharmacies and FDA has not taken action to limit the off-label use of Avastin. FDA has discussed with Genentech developing Avastin for the treatment of macular degeneration and studying its use in ocular indications. Further, FDA continues to monitor adverse reaction reports related to this off-label use. To date, the adverse reactions reported to FDA following use of Avastin for ocular indications have been consistent with the adverse reactions reported for Lucentis. FDA notes that Avastin is a sterile product and that its off-label use for ophthalmic diseases sometimes involves repackaging Avastin into multiple smaller doses for administration. The agency is concerned about the manipulation of sterile products because of the increased risk of product contamination.

Christopher C. Kelly
Office of Public Affairs
Food and Drug Administration

I’ve followed up with emails to Mr. Kelly and to Genentech asking the following questions:

  1. What are the specific FDA concerns that Genentech is referring to in the following statement? “In order to resolve the concerns raised by the FDA, we destroyed four batches of Avastin 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.)”
  2. The same letter says, “Genentech also agreed that it would reinstate its supply of Avastin to compounding pharmacies if the FDA gave the company legal and regulatory authorization to do so.” Has Genentech requested this authorization or does it intend to? What would have to be done to obtain such authorization?
  3. The Warning Letter sent to New England Compounding Center on December 4, 2006, states “we are in receipt of a complaint alleging that you are repackaging …Avastin…” Who filed that complaint?
  4. According to the AAO’s letter, Genentech has agreed to “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.” Is this in fact the case? If so, what is gained from putting an extra step between Genentech and the compounding pharmacists?

Stay tuned. I’ll be sure to let you know what I find out.

—–

PS –A Genentech representative left me a voicemail this afternoon and I hope to connect with her tomorrow.

October 31, 2007

5 thoughts on “Avastin update: Still seeking answers”

  1. Pingback: WorldHealthCareBlog.org » Genentech explains Avastin distribution changes: a hosted discussion on innovation in health care
  2. Twenty-five years ago, I was diagnosed with an autoimmune disease that caused inflammation in my right eye. I was treated with lasers that left my right eye legally blind.

    In 2005, the symptoms reappeared in my left eye. After a year of ineffective treatment with systemic steriods, and the intense fear of ending up completely blind, my retina specialist inject the eye with Avastin. That was 450 days ago and I am symptom free after just one injection.

    I am incredibly grateful for my physician’s courage, and for the miracle that is Avastin.

    I have excellent medical insurance that paid for my offlabel Avastin treatment, but many of my patient peers do not have this luxury. For many of them, taking away Avastin will mean the difference between 20/20 and blindness. Genentech needs to admit that they screwed up by investing millions of dollars on a me-to drug, and lower the price of Lucentis to its rightful market value. And stop hiding behind the FDA.

    I work in the drug development industry, and though I usually take pride in my work, issues like this leave me ashamed to be an enabler.

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