On/Off Label

Pharmaceutical companies are constantly being berated/fined for overzealous salespeople selling drugs off label to doctors/pharmacies. In the recent case of Genentech's Avastin, the shoe appears to be on the proverbial other foot. Earlier this month, Genentech made the decision to restrict the availability of Avastin to compounding pharmacies. It seems that they were dividing and repackaging the product as a cheaper alternative treatment for wet age-related macular degeneration (AMD). The problem is that this product is not approved for such use and the company already manufactures a more expensive (and approved) AMD treatment, Lucentis.  The two drugs share a similar mode of action by inhibiting vascular endothelial growth factor. Lucentis was designed specifically for the treatment of wet AMD, but costs thousands of dollars more when compared to Avastin. The American Academy of Ophthalmology (AAO) has strongly criticized the move. The AAO has said that "Genentech's decision to restrict availability of the drug has much wider implications than just for AMD patients." This is because ophthalmologists also use Avastin "off-label to treat diabetic retinopathy, macular edema and various other sight-threatening disorders." That's not all. Genentech cited FDA concerns with the sterility and repackaging of Avastin for ocular use as a reason for its actions in the letter to the AAO. In an e-mail back to AAO by the FDA, it states that the 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." While the FDA did cite concerns with sterility, it also said the FDA "has discussed with Genentech developing Avastin for the treatment of macular degeneration and studying its use in ocular indications." So let me get this straight. The AAO is complaining because they use a product off label. The FDA acknowledges that the product is being used off label. Nowhere did I see that the AAO was donating money so clinical trials could be run on Avastin for this use. I also didn't see an automatic approval by the FDA. The drug company is not suggesting that any of this happens.  Somewhere along the line this Drug Manufacturer/Doctor-Pharmacist/FDA approval process got messed up and maybe everybody is to blame.