On Tuesday, ASA Immediate Past President Jim Grant, M.D., M.B.A, FASA testified before a Food and Drug Administration (FDA) meeting on Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions. The meeting, organized by the Duke University Margolis Center for Health Policy— in cooperation with the FDA— was convened to permit drug shortage stakeholders to provide input on the underlying systemic causes of drug shortages and to make recommendations for actions to prevent or mitigate drug shortages. Dr. Grant shared physician anesthesiologists’ experiences with drug shortages and provided information about ASA’s drug shortages registry, where members and the public can report drug shortages.
In advance of the meeting, ASA and other healthcare groups, had issued a series of recommendations to address shortages, which were the product the September Drug Shortage Summit, focusing on Drug Shortages as a Matter of National Security: Improving the Resilience of the Nation’s Healthcare Critical Infrastructure, held at ASA’s D.C. office. Meeting attendees offered input and ideas for solutions, some of which aligned with ASA’s recommendations.
Some of the panelists advised that a multi-stakeholder committee be formed to work with the FDA. One of the recommendations from ASA and the other drug shortages summit conveners includes creating a multi-stakeholder advisory panel with the FDA to address key issues. Another theme was transparency; multiple panelists and member attendees expressed the need for greater transparency and increased communication within the drug supply chain. ASA also agrees with this concept and it is included among the summit recommendations. Other potential areas for action that were discussed during the FDA meeting include improved contracting, tax incentives, reliable quality monitoring systems, and reimbursement changes.
Other Task Force presentations focused on federal efforts to prevent drug shortages; the economics of drug shortages; health impact and economic consequences; manufacturing and supply challenges; drug purchasing and demand challenges; and strategies and next steps to reverse adverse clinical and economic consequences. The panels were comprised of representatives from the FDA; suppliers, compounders, and manufacturers; group purchasing organizations, payors, hospital administrators and pharmacists; Health Canada and others.
The Drug Shortages Task Force was formed in July by Commissioner Gottlieb after receiving requests from Congress to further examine shortages and recommend permanent solutions. ASA partnered with the American College of Emergency Physicians to advocate for this task force, working with Congress to ensure 107 representatives and 31 senators signed-on to a formal communication to Commissioner Gottlieb requesting that FDA renew its focus on this major public health issue.
Following the meeting, the public still has opportunity to comment through the FDA docket and ASA will submit formal comments. The Interagency Drug Shortages Task Force will take into consideration the feedback it receives and continue to work on its recommendations. The Task Force will submit a report to Congress with recommendations in the near future.
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Submit your own comments to the FDA docket through January 11, 2019