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Editorial: Incredible!!!!
Genentech's decision to restrict the use of its drug Avastin by ophthalmologists is one of the most incredible (selfish, greedy) decisions I have seen this year by the pharmaceutical industry. In case you are not up to par on this, Avastin, a cancer drug, has been routinely used for the treatment of macular degeneration. Pharmacists have been purchasing the drug (for use on prescription by ophthalmologists) and, since there are several doses per vial, prefilling individual sterile syringes that are administered by the physician at a cost of about $50 per dose.
Now, however, Genentech has a new drug on the market, Lucentis, to treat the disorder at a cost of about $2,000 per dose. Sales of Lucentis have not met Genentech's projections because Avastin is being used for the same disorder; their answer is to curtail the use of Avastin so they can sell their more expensive drug! This curtail is to begin November 30.
One reason for this move was given in one of Genentech's notices:
�the FDA raised concerns related to the sterility and repackaging of Avastin for ocular use in a Warning Letter to a compounding pharmacy and, separately during a routine FDA inspection of our (Genentech) South San Francisco manufacturing facility, concerns were raised by inspectors related to the ongoing ocular use of Avastin because it is not designed, manufactured or approved for this use�
Interestingly, a communication from the Office of Public Affairs of the Food and Drug Administration dated October 16, 2007 states:
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.
Obviously, there is always the potential for contamination during manufacturing, packaging, repackaging, and especially during use. Any contamination could lead to serious eye infections. However, keep in mind that the number of adverse events related to compounding is minimal (even though exaggerated by the media) when compared to other health professions/professionals and facilities.
What may now happen is that ophthalmologists may obtain the drug and do the splitting into multiple doses in their offices using procedures that do not meet the standards for USP <797> sterile compounding regarding personnel training, facilities, equipment, supplies, testing, etc.
Also, what may happen in many cases, due to the greediness of Genentech, is that many patients may go blind because they can't afford a $2,000 drug! I can't believe the third-party payors will stand for this and pay for the $2,000 drug when they could pay for a $50 drug that is "repackaged" by compounding pharmacists. So much of what they pay for already is "off-label."
Another aspect for consideration is that the government may end up paying the $2,000 instead of the $50 per dose; so now we have Genentech being subsidized by the Federal Government!
From the American Society of Retinal Specialists, we see the following response: (Excerpts presented)
As you know, Genentech's decision to halt sales of Avastin to Compounding Pharmacies as of November 30th has caused widespread outcry in the retina community. Since this decision was announced much behind the scenes activity has taken place. We write to update you on the response of the ASRS thus far.
The ASRS has consulted with the AAO, the FDA, Genentech, congressional representatives, the compounding pharmacy industry, and legal counsel.
We have also received extensive and valuable input from our membership at large.
In part as a result of these conversations, Genentech executives have scheduled a meeting to discuss their response to the protests from the ophthalmic community as a whole and have told us that they will have further response within two days. We look forward to more news on this front.
Senior executives at Genentech have been contacted repeatedly by ASRS leadership in order to strenuously protest the Avastin decision, strongly advise the company of the absolute opposition of our membership to any limitation of our patients' access to this widely used drug, and make clear the implications of the company's adherence to their decision. The FDA statement was discussed in further conversations tonight. Senior Genentech leadership described for the first time the actual circumstances of the FDA inspection of one of their oncology plants. In this inspection, the inspector reportedly looked at the particulates in the IV Avastin lots and specifically noted that these were too high for ophthalmic use. The contracts with compounding pharmacies were specifically asked for and reviewed, with verbal warnings about promotion of off-label use of the drug. As a consequence of this inspection, Genentech had to destroy four lots of Avastin.
2) Many compounding pharmacies have large supplies of Avastin and anticipate being able to keep up with the demand from the retina community, even if the November 30th cutoff holds, until well into the spring or summer. Thus we do not anticipate any imminent crisis for our patients who need the drug.
3) Several pharmacies have come forward to say that they have already worked out strategies for continuing legally to order and supply Avastin after November 30th despite the new Genentech policy. We are checking on these statements.
4) Several of our members have written to describe their in-office aliquoting of Avastin from the marketed vials.
5) We have asked OMIC to reconsider their position on physicians individually drawing up Avastin doses from multiuse vials.
6) We have obtained preliminary legal advice that suggests that there may be no adverse issue with physicians ordering Avastin and giving it to pharmacies to aliquot for them.
7) Some of our membership have taken a leadership role in contacting their congressional representatives and working to oppose the Avastin decision and/or to work around its strictures.
8) We have also started to explore the legalities of numerous possible sanctions of Genentech by our society and its membership in the event of corporate non-response.
Thank you for your many thoughtful commentaries and emails, and the positive force you bring to our patients' eye care The ASRS will continue to pursue all options on behalf or our patients, our specialty, and our colleagues here and around the world.
Sincerely,
Julia A. Haller, MD
on behalf of the ASRS Executive Committee
Obviously, we have a great deal of respect for ASRS for putting their patients first!
Regarding the actions of the FDA, while it is good to see the FDA distance itself from Genentech's decision, the agency is not as innocent as their statement claims. Genentech cites as partial justification for its decision an FDA action that resulted in a warning letter to a compounding pharmacy declaring the compounding of Avastin for eye conditions to be both illegal and unsafe. This is yet another example of how FDA's extreme position that all compounding is illegal can affect patient medical care. The FDA can't have it both ways, and they need to reexamine their position.
Meanwhile, aren't we glad the pharmaceutical industry has the patients' best interests at heart?
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
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