Senators concerned about draft FDA guidance on repackaging biologics

Leaders of the Senate Special Committee on Aging yesterday expressed concerns with the Food and Drug Administration’s draft guidance for compounding and repackaging biologics. “In particular, we are concerned that the beyond-use-dates proposed in the draft guidance would not allow doctors enough time to receive repackaged pharmaceuticals from compounding pharmacies and treat patients before the drug’s beyond use date passes,” Committee Chairman Susan Collins (R-ME) and Ranking Member Claire McCaskill (D-MO) said in a letter to Health and Human Services Secretary Sylvia Burwell. “These time constraints may limit physician access to repackaged drugs, which would in turn limit patient access to treatment options. Limiting access to repackaged pharmaceuticals could end up costing Medicare billions over the coming decade.” Specifically, the letter cites the major cost difference between certain repackaged and other drugs used to treat age-related macular degeneration and other eye diseases, and requests additional information on the FDA’s analysis and rationale for the guidance. In comments submitted last month, AHA also expressed concern that the proposed beyond-use-dates are inappropriately short and may limit patient access to critical biological products.