AHA recommends changes to FDA guidance to preserve access to drug/biological products

The AHA today urged the Food and Drug Administration to revise its draft guidance for mixing, diluting or repackaging biological products to permit longer beyond-use-dates if testing or validated studies show increased sterility and stability in a similar environment. “The AHA is concerned that the proposed ‘beyond-use-dates’ are inappropriately short and may limit patient access to critical biological products,” wrote Linda Fishman, AHA senior vice president for public policy analysis and development. “The AHA urges the FDA to address this concern, thereby helping to ensure that high-quality and safely mixed, diluted and repackaged biological products continue to be provided to patients without disruption.” In a separate letter, AHA also recommended changes to draft guidance for preparing repackaged drug products to address concerns related to anticipatory repackaging and beyond-use-dates. “We urge FDA to address these concerns to ensure the continued safety and availability of repackaged medications, including those that are sold by outsourcing facilities and those prepared in-house by hospital and health care system pharmacies,” Fishman said. The letters are available at www.aha.org/letters.