We've been following the recently released report from the Government Accountability Office (GAO) regarding drug shortages and a subsequent hearing held by the Energy & Commerce Committee's Health Subcommittee in the House of Representatives. The report was issued as a result of the Food and Drug Administration Safety and Innovation Act (FDASIA), which Children's Cause advocated for. Economics and quality control issues are cited as the main factors that contribute to shortages. The report confirms that despite new procedures in place that have enabled the Food & Drug Administration (FDA) to make progress in addressing existing and potential shortages, the agency needs to improve its ability to alleviate the numerous continued shortages of vital drugs and to analyze trends early enough to prevent further shortages. Most worrisome is the actual impact to patients as providers report that they are forced to delay or ration certain medications, negatively affecting patient care.
During the hearing, Members of Congress questioned whether the FDA required new authorities to more effectively manage drug shortages and discussed concerns about facility modernization being promoted by FDA that may interrupt manufacturing processes. We are also awaiting a response from FDA about any efforts to specifically address the impact of drug shortages on pediatric oncology treatment.
Many clinicians and advocates in the childhood cancer field, including CCCA, are working to develop alternative strategies to prevent, alleviate and respond to the impact of drug shortages in our community. Our top priority will always be to ensure that children with cancer do not bear the brunt of any disruptions in access to medication. Are you experiencing any difficulties because of ongoing drug shortages?