Abstract
Medication shortages constitute an ongoing threat to patient care across the United States and affect nearly every aspect of health care. National drug shortages have been a recurring challenge of the US health care system but were markedly aggravated during the COVID-19 pandemic. Federal executive and legislative efforts to bolster the resiliency of the pharmaceutical supply chain have thus far fallen short. This Commentary reviews the leading executive and legislative initiatives proposed during the 118th Congress and the Biden administration to protect the national drug supply in the hope of avoiding future shortages. It will be up to the new (119th) Congress and presidential administration to take up this issue again and pursue remediation of the nation’s drug shortage problem. The health of the nation demands action by policy makers to mitigate drug shortages that give rise to discontinuity of care and thereby to a compromise of the national state of health.
Medication shortages constitute an ongoing, yet-to-be resolved threat to patient care across the US.1,2 Drug shortages can delay, or in some cases deny, critically needed treatments for patients. Shortages affect hospitals, medical providers, and patients in nearly every aspect of health care; from emergency rooms, to cancer clinics, to outpatient surgery and primary care. National drug shortages have been a recurring challenge of the US health care system but were markedly aggravated during the COVID-19 pandemic.1 At the time of this writing, the American Society of Health-System Pharmacists (ASHP) estimates that the number of active drug shortages is 271, down from an all-time high of 323 (first quarter of 2024).2 The ASHP goes on to state that “nearly half of all active shortages (48%) began in 2022 or earlier.”2 Generic Sterile Injectables (GSIs) have proven particularly vulnerable, representing an estimated 67% of the overall shortages encountered.3 “Shortages of GSI drugs can have substantial adverse impacts through treatment delays, the use of inferior alternatives, and an increased risk of medication errors.”4 Further, “shortages disrupt patient care and create costs for hospitals through increased staffing and more costly treatment alternatives.”4 It is against this backdrop that the executive and legislative branches of the US government set out to bolster the resiliency of this all-important pharmaceutical supply chain. This Commentary reviews the leading executive and legislative initiatives proposed to protect the national drug supply in the hope of avoiding future shortages.
Generic drugs consistently comprise the lion share of the drug shortages in question.5 The US Food & Drug Administration (FDA) “defines a drug shortage as a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug.”5 While anyone may report a shortage, most information about drug shortages is supplied by manufacturers. In general, drug manufacturers are required to notify FDA in advance of discontinuing a drug or an interruption in its supply. FDA's Drug Shortage Staff (DSS) within the Center for Drug Evaluation & Research (CDER) maintains a database of drugs determined to be in shortage and makes the list publicly available on its website. The list includes information on whether a drug is currently in shortage, has been permanently discontinued, and if the shortage has been resolved. “A shortage is considered resolved when FDA determines that supply is no longer exceeded by demand or projected demand.”5 Information about resolved shortages remains on the public website for 6 months, and discontinued shortages remain for 1 year.
Alarmed by the realization that the US was experiencing “a shortage of 15 cancer drugs due to manufacturing and supply chain issues,” the Biden administration saw to it that the FDA work with manufacturers to stabilize the supply of Cisplatin, Carboplatin, and Methotrexate, 3 of the most widely used generic drugs that have been staples of cancer treatment for decades.6 To help alleviate some of the strain caused by the shortages, FDA announced that it would allow the temporary importing of some targeted drugs. In addition, on July 28, 2023, the White House convened “leaders from across the generic oncology drug supply chain, patient advocates, caregivers, and health care providers” with an eye toward resolving any and all “supply chain disruptions.”6 The participants “identified key areas where industry, nonprofits, public-private partnerships, and government can work together to change the status quo and implement ongoing efforts led by nonprofit organizations to help assure patient access to needed medicines.”6
On November 27, 2023, the White House made known “New Actions to Strengthen America’s Supply Chains, Lower Costs for Families, and Secure Key Sectors.”7 Noteworthy proposals included, but were not limited to the “creation of the Council on Supply Chain Resilience.” The Council is charged with coordinating and promoting efforts across the government to build a more resilient supply chains; this includes “greater domestic production; a diverse and agile supplier base; built-in redundancies; a reliable transportation system; secure critical infrastructure; adequate stockpiles; safe and secure data networks; reliable food systems; and a world-class, globally competitive American manufacturing base and workforce.”8 In addition, the President indicated renewed reliance on the “Defense Production Act of 1950 [Public law 81 to 774] to make more essential medicines in America and mitigate drug shortages.”7 Plans for the creation of new “cross-governmental supply chain data-sharing capabilities” were also announced.7 Further crystallization of the future plans of the executive branch was enunciated on April 2, 2024 by the office of the Assistant Secretary for Planning and Evaluation (ASPE).9 The ASPE report, “Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States,” called for “collaboration with the private sector to develop and implement a Manufacturer Resiliency Assessment Program (MRAP) and a Hospital Resilient Supply Program (HRSP).”9 The desired effect of the “combination of these programs would bring transparency into the market, link purchasing and payment decisions to supply chain resilience practices, and incentivize investments in supply chain resilience and diversification in the supply chain—including domestic manufacturing—at a scale that would drive impactful change in the market.”9
Concurrently, both the Senate and the House of Representatives worked to craft binding legislation that would all but preclude future national generic drug shortages. The Senate Committee on Finance of the 118th Congress, led by Chair Ronald L. Wyden [D-OR] and Ranking Member Mike D. Crapo [R-ID], saw to the convening of a full Committee hearing on December 5, 2023.10 Having released a summary white article on the national generic drug shortages on January 25, 2024, the Committee went on to craft and issue draft legislation with an eye toward incentivizing hospitals and physicians to prevent and mitigate GSI shortages.11 Concurrently, Rep. Cathy Anne McMorris Rodgers [R-WA-5], Chair of the House Energy and Commerce Committee, issued a similarly minded draft legislation titled “The Stop Drug Shortages Act,” which, among other things, would suspend the Medicaid total rebate and additional inflationary rebates “for all generic drugs that are in shortage or at risk of experiencing shortages,” instruct the Centers for Medicare & Medicaid Services (CMS) “to gradually phase-out the [Medicare] rebate reduction or waiver for drugs exiting a shortage,” prohibit total rebates, and permit certain “compounding facilities to compound a drug within 30 days of appearing on FDA’s drug shortage list and to distribute and dispense a compounded drug within 180 days of such drug appearing on the drug shortage list.”12 Still further, the House Ways and Means Committee held a hearing on February 6, 2024 “to examine the pervasive problem of drug shortages and its harmful impact on patient access to care.”13 The Committee discussed financial incentives to maintain a supply of essential medicines and gave special attention to the dependence on foreign sources for drugs, drug ingredients, and medical supplies. Given the urgency of securing the supply of GSIs and other medications, it was the expressed hope of the aforementioned legislators that the Senate and House bills under discussion would be brought up for a vote with an eye toward enactment. Regrettably, none of the 8 GSI supply-focused bills introduced in the 118th Congress came up for a vote.
On February 14, 2024, the Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) issued a joint request for information to solicit public comments on the root causes of and potential solutions to the national drug shortages. At issue were the contracting practices and compensation models of Group Purchasing Organizations (GPOs) and drug wholesalers and the impact thereof on generic drug shortages. By the close of the extended public comment period (May 30, 2024), more than 11,000 comments had been received. This effort complements the FTC’s ongoing investigation, begun in 2022, into the prescription drug supply chain, pharmacy benefit managers (“PBMs”), and their impact on access to and affordability of medicines.14
It will be up to the new (119th) Congress to take up this issue yet again and pursue legislative remediation of the nation’s drug shortage problem. Likewise, the new executive administration (and new HHS secretary and FTC chair) will be called on to establish priorities for addressing this persistent challenge, one that has plagued health care providers and their patients, in this country and others, for too long. Numerous studies have pointed to “the global nature of drug supply chains.”15 As one recent study examining the differences in drug shortages in the US and Canada concluded, “Domestic production of drugs has been proposed as a solution to shortages, but the production of all medications domestically is cost prohibitive and may limit access. Importation of drugs on shortage may also decrease access and exacerbate international disparities in drug supply. Thus, coordinated or aligned strategies (eg, “nearshoring”) may prove to be beneficial to the global drug supply chain.”15 The health of the nation demands action by policy makers to mitigate drug shortages that give rise to discontinuity of care and thereby to a compromise of the national state of health.
Notes
This article was externally peer reviewed.
Funding: None.
Conflict of interest: Professor Adashi and Mr. O’Mahony declare no conflict of interest. Prof. Cohen is a member of the ethics advisory board for Illumina and the Bayer Bioethics Council and an advisor for World Class Health. He was also compensated for speaking at events organized by Philips with the Washington Post, attending the Transformational Therapeutics Leadership Forum organized by Galen Atlantica, and retained as an expert in health privacy, gender-affirming care, and reproductive technology lawsuits.
- Received for publication September 3, 2024.
- Revision received February 7, 2025.
- Accepted for publication February 24, 2025.
