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  • Washington Highlights

    AAMC Responds to FTC, HHS Request for Information on Drug Shortages


    Katherine Gaynor, Hospital Policy and Regulatory Analyst
    For Media Inquiries

    On April 9, the AAMC submitted comments to the Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) in response to a request for information (RFI) focused on root causes of and potential solutions to generic drug shortages. Specifically, the RFI focused on the role of large group purchasing organizations (GPOs) and drug wholesalers.  

    In its comments, the AAMC highlighted the need to address drug shortages and emphasized the serious effects shortages have on the ability for health systems and hospitals to provide care. The association also made note of the important role that GPOs play in assisting health systems and hospitals in contracting for drugs and supplies to ensure a stable and resilient supply. Specifically, the comments outlined GPOs’ ability to evaluate manufacturer reliability and quality, including the stability of their supply, in addition to cost efficiencies that are created through these contract negotiations.  

    The AAMC also urged the agencies to explore policy options to further focus on quality and resiliency needs by working with the Food and Drug Administration to further develop and incentivize manufacturers to participate in the Quality Management Maturity (QMM) rating system as well as the Quality Metrics (QM) Reporting Program to better predict supply chain and manufacturing vulnerabilities. Lastly, the comments urged the agencies to work with Congress and the Centers for Medicare & Medicaid Services to consider payment adjustments to providers for generic essential medications frequently in shortage, when contracting with manufacturers that agree to supply chain mitigation and resiliency requirements, such as participation in the QMM rating system.