- FDA draft guidance seeks to restrict the amount of time a biologic can be used after repackaging by a compounder.
- If passed, this law will affect the ability of compounders to repackage Avastin (bevacizumab) for treatment of wet age-related macular degeneration (AMD). Avastin is an equally effective (according to a Cochrane review) and much cheaper option than Lucentis (ranibizumab)---$50 per treatment versus $2,000 per treatment. Both Avastin and Lucentis are made by Roche.
- The goal is to avoid problems such as the well-publicized outbreak of fungal meningitis that occurred due to mishandling of compounded drugs at the New England Compounding Center (NECC) in 2012.
This situation represents the convergence of two major stories. The first story deals with the deaths of 64 people who received tainted drugs from NECC. As a result, the FDA has begun cracking down on compounding pharmacies. Draft guidelines include new laws that would cap interstate shipments at 30%, as well as a law that would require any biologic that is mixed, diluted or repackaged by a compounder be administered within four hours, or be thoroughly tested for microbial contamination. And now comes the latest proposed rule---that a repackaged drug be used within five days.
That's where the story of Avastin for treatment of AMD comes in. Given the major price difference between Avastin and Lucentis and the widespread practice of physicians using Avastin off-label to treat AMD, having access to Avastin in the proper doses is critical. Off-label use of Avastin has been controversial -- in fact, both Avastin and Lucentis are vascular endothelial growth factor (VEGF) inhibitors, which inhibit angiogenesis. Although Avastin is indicated for treatment of solid-tumor cancers, it can also be used in wet AMD in very small doses. This requires compounding.
As the draft legislation evolves, there will have to be clauses for exceptions or some other way of dealing with the Avastin situation. No matter what develops there, it's still clear that stricter FDA oversight of compounding pharmacies is absoutely necessary.