Drug Shortages Reach an All-Time High; HHS Announces New Strategies and Policy Considerations

The previous drug shortage record was set (https://www.ashp.org/drug-shortages/shortage-resources/drug-shortages-statistics) in 2014 with 320 drugs. More than 15 of the medications (https://ascopost.com/issues/march-10-2024/asco-chief-medical-officer-testifies-to-congress-about-ongoing-cancer-drug-shortage-crisis/) in short supply are cancer treatments, including carboplatin and cisplatin.

In a press release announcing the white paper, HHS summarized (https://www.hhs.gov/about/news/2024/04/02/hhs-releases-white-paper-focused-preventing-drug-shortages.html) its work addressing the shortages to date:

• Made improvements in how it monitors the pharmaceutical supply chain and responds to disruptions
• Established a supply chain resilience and shortage coordinator role to strengthen implementation of strategies for pharmaceuticals and other medical products
• Issued guidance (https://www.fda.gov/drugs/drug-shortages/coronavirus-aid-relief-and-economic-security-act-cares-act-drug-shortage-mitigation-efforts) to increase supply chain transparency
• Initiated a request for information (https://www.hhs.gov/about/news/2024/02/14/ftc-hhs-seek-public-comment-generic-drug-shortages-competition-amongst-powerful-middlemen.html) jointly with the Federal Trade Commission to better understand the causes and potential solutions for generic drug shortages
• Made investments to support active pharmaceutical ingredient (API) manufacturing
• Explored its new authorities (https://www.whitehouse.gov/briefing-room/presidential-actions/2023/12/27/memorandum-regarding-the-presidential-determination-and-waiver-pursuant-to-section-303-of-the-defense-production-act-of-1950-as-amended-on-essential-medicines-medical-countermeasures-and-critical/) to promote the onshoring of essential medicines, medical countermeasures, and their critical ingredients
• Developed policies to foster a more diverse supply chain

In the new white paper, HHS calls for (https://aspe.hhs.gov/reports/preventing-shortages-supply-chain-vulnerabilities) U.S. Congress to consider policy concepts to bring transparency into the market, link purchasing and payment decisions to supply chain resilience practices, and incentivize investments in supply chain resilience and diversification. Proposed strategies include private sector collaboration to develop and implement programs for manufacturer resiliency assessment and hospital supply resiliency.

Access to cancer care—including the ideal medications to achieve the best outcomes—is an ONS health policy priority (https://www.ons.org/make-difference/ons-center-advocacy-and-health-policy/health-policy-priorities-and-agenda). ONS (https://www.ons.org/sites/default/files/2024-03/Drug%20Shortages%20Senate%20Finance%20Web%20version.pdf) and other cancer and health organizations, including the American Hospital Association (https://www.aha.org/news/headline/2024-02-06-aha-recommends-legislative-action-address-chronic-drug-shortages) and American Society of Clinical Oncology (https://ascopost.com/issues/march-10-2024/asco-chief-medical-officer-testifies-to-congress-about-ongoing-cancer-drug-shortage-crisis/), are calling on Congress to “identify a long-term, nationally coordinated solution to overcome drug shortages that ensures access to safe, high-quality cancer care (https://www.ons.org/sites/default/files/2024-03/Drug%20Shortages%20Senate%20Finance%20Web%20version.pdf).”

Both chambers of Congress are discussing legislation to address drug shortages, including the Mapping America’s Pharmaceutical Supply Act (House (https://matsui.house.gov/sites/evo-subsites/matsui.house.gov/files/evo-media-document/matsui_038_xml_v4.pdf), Senate (https://www.congress.gov/bill/118th-congress/senate-bill/2364/text/is?overview=closed&format=xml)). The House launched an investigation (https://voice.ons.org/advocacy/house-committee-launches-investigation-into-nationwide-shortages-of-medications-including) in late February, and the Senate Finance Committee announced in March (https://voice.ons.org/advocacy/this-weeks-advocacy-news-wyden-crapo-release-plan-to-prevent-and-mitigate-generic-drug) that it is taking a hard look at the issue.

Policymakers need to hear nurses' stories about how drug shortages are affecting your patients and your ability to provide quality care. Look up your legislators on the ONS Action Center (https://www.votervoice.net/ONS/Home) and raise your voice to support current and future policies to eliminate drug shortages.