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Special Report Special Report

Drug shortages on the rise; US Government cusses may be relevant for other mar- developed in collaboration with external from more resilient manufacturers and
kets as well.
organizations, MRAP metrics could supply chain systems. The expected
proposes new actions to address One proposal by HHS is for Con- refl ect manufacturers’ quality manage- term of a non-profi t organization is
to be determined; it would need to be
ment maturity, manufacturing redun-
gress to create new authorities and pro- dancy, and API/key starting materials long enough to ensure effi ciency and
he number of drug shortages in practices that are more resilient. HHS PATRICIA VAN ARNUM vide additional funding to develop and sourcing diversity, among other resi- continuity, as well as accountability to
the US has reached a new all- has also collaborated with other govern- implement a MRAP and a new HRSP lience-related metrics. These metrics HHS. After expiration of the term, the
Ttime high, with more than 320 ment agencies on this critical issue. Editorial Director (Figure 1). Through a public-private would be intended to enhance transpa- non-profi t organization(s) must seek
Drug, Chemical & Associated
drugs in shortage, according to an For example, last month (March 2024), Technologies Association,Inc. (DCAT) partnership, the MRAP would measure rency about manufacturer management renewal and approval to operate as part
analysis by a pharmacist trade group. HHS and the Federal Trade Commis- manufacturer resilience practices and practices. MRAP would provide over- of the accreditation body. HHS says
Recently, the White House proposed sion jointly issued a Request for Infor- New proposals to address drug shortages assign manufacturers scores based on sight of a non-governmental national that this governance model enables
new actions to address the problem, mation to better understand the causes – HHS says that effective longer-term their performance (i.e., develop a reli- accreditation body and conduct core accountability of a non-government body
including additional requirements for and potential solutions – of generic solutions may require additional able manufacturer metric). The HRSP activities including establishing to HHS and leverages capability and
manufacturers. drug shortages. authorities and resources to align market would establish fi nancial incentives accreditation standards, collecting data, expertise in HHS and industry. It also
incentives in order to reward invest- and/or penalties to hospitals based conducting analyses, developing and fosters transparency and participation
White House takes action HHS has also taken steps to increase ment in supply chain resilience. It on a combination of meeting certain submitting reporting requirements and from industry.
Earlier this month (April 2024), the resilience and redundancy within the issued a white paper to outline these requirements and performance on a hos- consulting with a new or established
US Department of Health and Human market. This work includes supporting proposals, which include developing pital scorecard. The hospital scorecard group of experts. The national accredi- Hospital Resilient Supply Program
Services (HHS) released a white paper domestic manufacturing of key ingre- and implementing a Manufacturer would be developed by HRSP and tation body would be established by The second HHS proposal seeks
highlighting steps HHS has taken to dients and drugs to address various vulner- Resiliency Assessment Program (MRAP) could include reliant manufacturer external non-profi t organizations that to create a foundation for improved
prevent and mitigate drug shortages abilities. ASPR has invested $500-mn and a Hospital Resilient Supply Pro- metrics developed by MRAP and hos- meet HHS standards and requirements supply-chain resiliency for prescrip-
and proposing additional solutions for to date (April 2024) to support active gram (HRSP). The white paper outlines pital pro-resilience purchasing behaviour for accreditation; these include, but are tion drug demand. Under the HHS
policymakers to consider. pharmaceutical ingredient (API) how these programs could operate and metrics developed by HRSP using not limited to, annual audits, person- proposal, a HRSP could establish
manufacturing and is exploring how it help address the broader market issues attestations or other information report- nel qualifi cations, recordkeeping and demand incentives and/or penalties by
Actions taken to date can utilize new authorities authorized that lead to drug shortages. It focuses ed to CMS by hospitals. reporting. The national accreditation facilitating hospital purchasing that prio-
Through the Assistant Secretary by the President last year (2023) to pro- on the generic sterile injectable (GSI) body would conduct manufacturer ritizes supply chain resilience, rather
for Planning and Evaluation (ASPE), mote the onshoring of essential medi- drugs that form the basic layer of hos- A Manufacturing Resiliency Assess- assessments based on criteria developed than the current structure in which the
Administration for Strategic Prepared- cines, medical countermeasures, and pital care and make up the majority of ment Program by the MRAP and report the ratings to HHS generally prioritizes cost alone.
ness and Response (ASPR), the Food their critical ingredients. Moreover, shortages, which occur across thera- Under HHS’ proposal, a MRAP HHS. Manufacturer assessments would To start, hospitals that provide inpatient
and Drug Administration (FDA), the HHS is developing policies to foster peutic areas. However, HHS says that could measure resilience of manufac- be paid by manufacturers. services would need to consider quality
Centers for Medicare & Medicaid Ser- resiliency by considering Medicare pay- that these challenges affect other medi- turers and bring transparency to the management maturity and the reliabi-
vices (CMS), and others, HHS has been ments, and additional requirements, to cal products, and expects the concepts prescription drug supplier base. Actors Under the proposal, manufacturers lity of drug supply in their purchasing
working to improve how the depart- support a more diverse supply chain. and solutions that this white paper dis- throughout the supply chain could use would be incentivized to participate practices.
ment monitors the pharmaceutical sup- this information to better inform drug based on the expectations that hospi-
ply chain and responds to disruptions. development, purchasing, production, tals would use this information in their At its core, the HRSP would draw
HHS has established a new Supply and other activities. Through a public- purchasing decisions and would be on the same principles behind existing
Chain Resilience and Shortage Co- private partnership, a private entity willing to pay higher prices for drugs CMS programs, such as the Promot-
ordinator role to strengthen implemen- administering the MRAP would assign
tation of strategies to enhance supply Incentives Scorecard/Metrics includes attestation Develop manufacturer resilience assessment resilience scores to manufacturers of
measures or other hospital factors
index or ratings for select group of drugs*
chain resilience for pharmaceuticals and/or penalties determined by CMS generic drugs, based on an assessment of
and other medical products, and has in fi rst 5 years Scorecard/Metrics includes attestation measures, manufacturer practices and past perfor-
issued guidance to increase supply hospital factors determined by CMS and/or Assessment expands drugs eligibility criteria mance. The MRAP could develop new
ratings or assessment index from MRAP
chain transparency while continuing Penalties only manufacturing resilience metrics (e.g.,
to consider additional long- and short- starting in year 6 manufacturer and/or product ratings)
term solutions. FDA discloses certain Scorecard/Metrics adds other drugs or devices, Assessment expands to other drugs or devices, and a process to assess manufacturers’
if feasible
potentially expands to hospital outpatient setting
inspection information to provide the practices to address market information
public with an understanding of * MRAP may need 1-3 years to stand up, establish standards/requirements, develop metrics, failures and promote improvements in
implement inital assessments, and report data.
actions the agency takes to protect public Fig. 1: Illustrative Timeline for Manufacturer Resiliency Assistance Program (MRAP) and manufacturing performance.
health and is also developing a quality Hospital Resilient Supply Program (HRSP)
management maturity framework that Source: US Department Health and Human Services “Policy Considerations to Prevent Drug Shortages While specific metrics have not
may support adoption of manufacturing and Mitigate Supply Chain Vulnerabilities in the United States,” Whitepaper (April 2024). yet been developed, and would be

190 Chemical Weekly April 30, 2024 Chemical Weekly April 30, 2024 191

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