Agency Drug Shortages Task Force
The Task Force
In July 2018, FDA Commissioner Scott Gottlieb, M.D. established the Agency Drug Shortages Task Force to identify the root causes of drug shortages and advance potential long-term solutions in a report to Congress.
In October 2019, the FDA issued a report, “Drug Shortages: Root Causes and Potential Solutions,” that identifies root causes and offers recommendations for government and industry based on insights gleaned from FDA analysis of data, published research, and stakeholders in the private and public sectors.
Membership and Leadership
Led by Keagan Lenihan, FDA’s Associate Commissioner for Strategic Initiatives the Agency Drug Shortages Task Force includes federal officials from several agencies concerned with drug shortages. Within the U.S. Department of Health and Human Services, these include FDA, the Centers for Medicare & Medicaid Services, and the Office of the Assistant Secretary for Preparedness and Response. The task force also includes representatives from the Department of Veterans Affairs and the Department of Defense.
In response to strong stakeholder interest, the task force is providing three ways for stakeholders to participate:
- Public Meeting. The task force, under a cooperative agreement with the Robert J. Margolis, MD, Center for Health Policy at Duke University, will host a public meeting on November 27, 2018, in Washington, D.C. Dr. Mark McClellan, Director of the Duke-Margolis Center and former FDA Commissioner and CMS Administrator, will moderate the meeting. The agenda will include opportunities for open discussion and audience participation.
- Stakeholder Listening Sessions. The task force held a series of stakeholder listening sessions in September and October 2018. Due to resource constraints, participation was by “invitation only.” The sessions brought together small groups of nationally recognized experts on the drug supply chain and leaders of organizations representing broad segments of the health care system.
- Public Docket. FDA has opened a docket to receive comments from stakeholders about the root causes of drug shortages and potential enduring solutions. The docket will remain open until January 11, 2019, to provide ample time for contributions.
- FDA is Advancing New Efforts to Address Drug Shortages
- The Commissioner's Statement on the task force formation
- Federal Register Notice announcing the public meeting and docket
- Duke-Margolis Center for Health Policy website where you will find:
- Registration for the public meeting
- Agenda for the public meeting
- Discussion guide for the public meeting (posting expected around November 12, 2018)
Frequently Asked Questions:
Question: How can I participate in the work of the task force?
Answer: The task force is comprised of federal officials, but stakeholders can participate by attending the November 27, 2018 public meeting and by submitting comments to the public docket through January 11, 2019.
Question: How can I attend the public meeting?
Answer: To register for the public meeting, please visit the Duke Margolis Center for Health Policy website.
Question: Can I reserve time to speak or present slides at the public meeting?
Answer: We are not reserving time for stakeholders to speak or present slides at the public meeting. However, they are welcome to submit their comments, presentations, or research publications to the docket.
Question: The Task Force held listening sessions with select stakeholders. Who participated in the listening sessions?
Answer: The Task Force held listening sessions on various topics with select nationally recognized experts and associations that represent constituents drawn from major segments of the health care system.
- federal partners
- medical organizations and associations
- pharmacists and hospitals
- drug manufacturers and trade associations
- group purchasing organizations, distributors and payers
Question: Will the task force publish a transcript or summary of the listening sessions?
Answer: No, the task force does not intend to publish a transcript or summary. However, listening session participants are free to enter their comments in the docket, where they will be visible to the public.