Pharmaceuticals and vaccines play critical roles in protecting the public's health in the United States. Disruptions in the pharmaceutical and vaccine supply chains can undermine the United States' ability to reduce morbidity and mortality during public health emergencies by limiting access to critical drugs needed to treat patients and preventing effective collaborations with the private sector to develop and distribute vaccines. To ensure patients have access to lifesaving treatments, the United States must develop and implement strategies to mitigate risks and vulnerabilities in these supply chains, as well as strengthen domestic manufacturing capabilities, particularly during public health emergencies.Current SituationA strong pharmaceutical supply chain should include:• The ability to manufacture certain high-quality products in the United States;• Drug supply chain diversification;• As well as supply chain redundancy (e.g., having multiple manufacturers for each product and its precursors).The US government currently has limited visibility into the pharmaceutical supply chain. • As well as supply chain redundancy (e.g., having multiple manufacturers for each product and its precursors).The US government currently has limited visibility into the pharmaceutical supply chain. API manufacturers' locations for FDA-approved or authorised prescription drugs are more well-known than those for over-the-counter products. Because not all approved sites are continuously active, data on the volume of pharmaceuticals and APIs manufactured is difficult to obtain. As a result, data is not collected in a way that accurately depicts current end-to-end production.Key Starting Materials (KSM): The US government has little knowledge of the supply chains for KSM. Aside from wage differences, certain foreign suppliers are not subject to the same environmental and public health safeguards as US manufacturers and can produce a lower cost than U.S.-based manufacturers. Overall, the US Government has insufficient data due to confidentiality practises among API manufacturers and KSM suppliers, making it difficult to properly understand and assess supply chain vulnerabilities.FDF (Finished Dosage Form): Some FDF is manufactured in the United States. HHS increased industrial base capacities for many drugs experiencing bulk production and fill-finish bottlenecks by investigating market influences across pharmaceutical supply chains and initiating direct investments in platform technologies and additional fill-finish capacity. HHS established capabilities for on-demand manufacturing of API and fixed-dose formulation drugs.Therapeutic Development: During the COVID-19 response, new therapeutic development was primarily focused on mAb therapeutics. These require some of the same resources as vaccines, such as glass vials. Although there are no current production issues with mAbs, production is limited due to the difficulty in obtaining the glass vials required to deliver and administer these therapeutics to patients. As a result, the public faces mAb shortages.Aside from mAbs, several other COVID-19 treatments are being investigated, including• 50 or more antivirals;• 60 or more cell and gene therapies;• 130 or more immunomodulators;• 60 or more neutralising antibodies;• 110 or more other single agent treatments• More than 40 combination agent treatmentsVaccines: Although not unique to vaccines, increasing capacity to manufacture biologic products such as messenger RNA vaccines and mAbs has resulted in the development of innovative manufacturing platform technologies that improve flexibility, mitigate cross-contamination risk, and reduce the time and cost of cleaning between manufacturing campaigns.The FDA continues to use all available tools to aid in the development and availability of vaccines and other biological products to combat the COVID-19 pandemic as quickly and safely as possible. The FDA is involved in numerous efforts to combat the COVID-19 pandemic, including• assisting in the acceleration of development programmes for vaccines and certain therapeutic biological products with the potential to prevent or treat COVID-19 through timely interactions, scientific advice, and recommendations for individual sponsors, as well as the issuance of guidance documents;• assisting with product development and facilitating the expansion of manufacturing capacity for high priority COVID-19 treatments, as well as conducting timely reviews;• accelerating the review of EUA requests and Biologics License applications for COVID-19 vaccines and other critical medical products, including the evaluation of booster doses of COVID-19 vaccines and the use of COVID-19 vaccines in certain paediatric populations;• assisting in the provision of an adequate and safe blood supply; and• providing information to healthcare providers and researchers to assist them in submitting expanded access investigational new drug application requests to allow the use of FDA-regulated investigational products for COVID-19 patients.Current Responses to Supply Chain VulnerabilitiesDomestic, direct production of APIs, including fine chemicals and catalysts, both of which are more prevalent in U.S. pharmaceutical production, and biologically derived APIs produced for antibiotics, are among the investments made to address API and KSM supply chain vulnerabilities. HHS investments to date total $105 million, resulting in prototypes for increased drug product capacities of more than 600 million doses for six medicines in short supply. HHS is working to identify current product shortages, forecast future shortages, and determine where and who manufactures the products. HHS will then implement mitigation measures to alleviate or eliminate the shortages by investing in domestic production.Creating an Essential Medicines List: In 2021, HHS convened several consortia of public health experts and clinicians from the government, non-profit, and private sectors to review the FDA Essential Medicines List18 and recommend 50 to 100 drugs that are most critical to have on hand at all times due to clinical need and a lack of therapeutic redundancy. An assessment of the critical drugs list is currently underway in order to identify vulnerabilities for those items, which will define strategies for ensuring domestic supply and production of essential medicines. HHS is collaborating with interagency partners to identify APIs that are at risk and critical to drug manufacturing through industrial-based assessments and inquiries. HHS is also investing in technology and infrastructure development to increase domestic capacity for the production of APIs for a wide range of essential medicines.Collaboration with the National Academies: Congress directed HHS to collaborate with the National Academies of Sciences, Engineering, and Medicine to assess the security and resilience of the medical products supply chain in the United States. The Committee on Security of America's Medical Product Supply Chain was tasked with assessing the United States' reliance on critical drugs and devices sourced or manufactured outside the country and making recommendations to strengthen the medical product supply chain by addressing these dependencies. Throughout 2021, the committee held information-gathering sessions to examine critical dependencies within the supply chain. The goal of these sessions was to learn about end-user definitions of essential medical devices, the formula for creating essential medical device lists, and the impact these lists have on decision-making in order to inform strategies for mitigating the impact of medical product supply chain failures. This topic is currently being investigated further.Interagency Collaboration: Two efforts for drug substance and drug product production are underway in collaboration with the Defense Advanced Research Projects Agency and the United States Air Force. The combined investments of approximately $105 million enable advanced continuous synthesis of APIs in support of sterile injectable analgesics and sedative medications manufactured in accordance with cGMP. The FDA will receive an abbreviated new drug application in Q1 2022 for the production of one of these drugs using these new methods.Developing Advanced Manufacturing Capabilities: To reduce the cost of domestic manufacturing of critical supplies, HHS is investing in the development of advanced manufacturing capabilities. Additional innovations will drive the development and deployment of novel manufacturing platforms, which will aid in the development of the domestic pharmaceutical industry. This work will address the critical need to bring drug product and drug substance production in-house. It will be critical to sustain this new domestic pharmaceutical ecosystem once it has been established. HHS will attempt to catalyse domestic pharmaceutical development by providing enabling factors that improve competitiveness. These efforts include, but are not limited to, increasing technological efficiencies (e.g., automation) in pharmaceutical processes to reduce production costs, enabling process intensification and scale-up, and improving data sharing and security to maximise collaboration and reduce redundancy in R&D efforts. To achieve these objectives, partnerships with private partners and within government, including those currently engaged in fostering the development and deployment of advanced manufacturing platforms, must be strengthened.Gains in automation and efficiency will not reduce the need for skilled labour, but will instead create new job opportunities throughout the supply chain. The gains and improvements will also improve worker safety by reducing exposure to hazardous environments and ensuring a safe, highly productive, and sustainable enterprise. Although these activities will increase domestic production of critical medicines and increase competitiveness, vulnerabilities will persist unless additional efforts are made.Furthermore, ASPR19 has begun to form a consortium with partners from the drug and vaccine manufacturing supply chain, including raw material and consumable manufacturers and fill-finish service providers, to transform and build core biodefense capabilities. The initial effort will concentrate on MCM manufacturing and the role that public-private partnerships can play in strengthening the nation's bio manufacturing infrastructure. It will help to expand the industrial supply chain for MCM production, manufacturing, and implementation. The consortium's goal is to build the physical infrastructure, manufacturing platforms, and supply chains necessary to produce enough vaccines for the entire US population in 130 days and the global population in 200 days after a potential emerging pandemic threat is identified. It increases the country's ability to produce therapeutics and critical supplies needed to avert future pandemics.Developing a Quality Management Maturity (QMM) Rating System: The HHS and FDA are developing a rating system to encourage drug manufacturers to invest in achieving QMM and long-term compliance. 20 The program's goal is to recognise manufacturers who have established mature quality management practises that emphasise continuous improvement, business continuity plans, and early detection of supply chain issues. The FDA collaborated with purchasers, pharmacies, and other federal agencies to develop this programme. The FDA has carried out two pilot programmes, one for domestic manufacturers of FDFs and one for foreign manufacturers of API, to develop an assessment framework that can be used to rate the maturity of observed quality management practises at participating sites.Detecting and Managing Supply Chain Disruptions: The FDA continues to build on current drug shortage initiatives by leveraging available data, increasing visibility among business partners, and identifying data gaps that must be filled to improve supply chain oversight. The Pharmaceutical Supply Chain Governance Board was recently established by the FDA's Centre for Drug Evaluation and Research (CDER) to facilitate and coordinate all supply chain initiatives across CDER and to provide strategic guidance on major supply chain issues.Allocating and Distributing Pharmaceuticals: The HHS Coordination Operations and Response Element (H-CORE) 21 is in charge of allocating mAbs on a state and territorial basis. HHS will continue to monitor therapeutic ordering and utilisation at the facility and state levels after allocation to prevent excessive stockpiling and wastage of therapeutic inventory. HHS is preparing for the distribution of molnupiravir and is monitoring inventory levels to detect supply disruptions and shortages sooner.Stopping Illegal Products: The FDA has issued over 260 warning letters regarding the sale of illegal, unproven products that claim to be effective for the treatment, diagnosis, or prevention of COVID-19. FDA has destroyed nearly 85,500 violate products in collaboration with CBP, totalling over 15,050,242 capsules, tablets, and other dosage forms of violate drugs.Vaccine Supply Chain Coordination with Industry: Currently, the FDA has authorised three COVID-19 vaccines for emergency use under EUAs, and two of these three have been licenced for use in specific populations. These vaccines necessitate the same resources as other vaccine candidates that are still in clinical trials. Balancing these priorities throughout the supply chain necessitates effective collaboration between the federal government and private industry. The H-CORE has been the focal point of much of this activity. The Federal COVID-19 Response Team and HHS have formulation and fill-finish manufacturing models aligned to known final package format for each vaccine candidate across a network of US-based capacities. Although vaccine capacity is primarily domestic, HHS monitors the supply chain for critical components. Depend on a number of factors, including the impact of variants.Actions Planned to Address Supply Chain VulnerabilitiesHHS will continue to invest in technology and infrastructure development to increase domestic capacity for the production of APIs used in a wide range of essential medicines. This includes technologies that will lead to more sustainable manufacturing techniques, more efficient manufacturing systems, and emerging research such as the use of biosynthetic pathways to potentially reduce supply chain footprint. The workforce is limited at all levels of research and development, as well as manufacturing, and more people are needed.Work with Global Partners: The United States government is proposing discussions with global partners to ensure cooperative agreements and near-shore capacities are available to diversify and sustain the supply chain, particularly during times of crisis.Increase Manufacturing Capacity: HHS intends to invest further in infrastructure to increase manufacturing capacity for single-use assemblies, as well as capacity expansion for domestic raw materials and special enzymes. It plans to invest $2.65 billion in three portfolio areas: vials, 22 fill-finish, 23 consumables, and raw materials. These investments will reduce risk in the vaccine supply chain and allow for effective response to future public health emergencies without repercussions in existing bio therapeutic markets.End-to-end continuous manufacturing has the potential to be used for both API and drug product manufacturing. Continuous manufacturing has the potential to reduce drug shortages while also raising or maintaining quality standards and keeping the industrial base globally competitive in this market. A variety of novel analytical and drug production technologies, such as portable and modular manufacturing platforms (e.g., pharmaceuticals on demand) and the use of 3D-printing technologies for solid dosage forms, may also be used in this area.Leverage Data: The Coronavirus Aid, Relief, and Economic Security (CARES) Act includes provisions that will allow the FDA to collect data on the quantities of API and FDF released for commercial distribution. This information could help future analyses by increasing transparency in the upstream supply chain and providing a more complete understanding of key manufacturers based on market share. Although this is reported on an annual basis, it will raise FDA awareness of potential issues before shortages occur, and domestic infrastructure investment could be prioritised based on the criticality of an essential medicine as well as supply chain resiliency.Although ongoing efforts address various aspects of the vaccine supply chain, they do not address every tier of the component parts, such as sand suppliers for glass and chemicals for lipid and nucleotide synthesis. In addition to vaccine, there is the possibility of stockpiling raw materials and other materials for vaccine development. To determine the feasibility of this approach, additional factors such as product expiration and the usability of the stockpiled materials in different scenarios must be investigated. Although consumables have expiration dates, stockpiling consumables may be more feasible than stockpiling bioactive materials. Vendor-managed inventory is another option, with vendors authorised to sell off supply at predetermined intervals. Alternatives to physical storage can also be considered, such as virtual stockpiles24, in which regular inventory buffers distributed across the supply network can be shifted as needed during a contingency response.
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