Drugs

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.

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.

Stakeholder Participation

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 will hold a series of stakeholder listening sessions in September and October 2018. Due to resource constraints, participation will be by “invitation only.” The sessions will bring 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.

Additional Information:

Frequently Asked Questions:

Question: How can I participate in the Agency Drug Shortages Task Force?

Answer: Only federal officials can formally serve on the task force itself, but stakeholders can participate by attending the public meeting, submitting comments to the docket, or in certain cases by attending a “Listening Session.”

Question: Can I reserve time to speak or present slides at the public meeting?

Answer: The task force is not reserving time for stakeholders to formally speak or present slides at the public meeting. We encourage interested stakeholders to submit their comments, presentations, or research publications to the docket.

Question: How can I attend a listening session?

Answer: The listening sessions will be intentionally small. We invited nationally recognized experts and associations that represent constituents drawn from major segments of the health care system. If you belong to such an association, you may wish to share your opinions with the official who will be representing you. We will also allow associations to bring along one member of their choosing, if they wish.

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.

Page Last Updated: 09/27/2018
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