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17 June 2020
Medical product shortage reporting requirements
Medical product shortage compliance vulnerabilities
Update 7 April 2020: Impact of the CARES Act
Preventing medical device shortages
Mitigating emergency drug shortages
It is vital for manufacturers of market-critical drug products to survey their supply chains and currently available product supplies to ensure compliance with reporting requirements. Further, while Food and Drug Administration (FDA) inspections of manufacturing facilities in China are currently not taking place, the FDA has increased import sampling and screening in order to continue monitoring product quality. Supply chain compliance efforts must be nimble and respond to the shift in FDA monitoring efforts.
As in past instances of worldwide disturbances, COVID-19 has unveiled the vulnerabilities of the medical product supply chain. It has highlighted the industry's reliance on a complex system of import and export regulations, skilled workers, the availability of raw materials, active pharmaceutical ingredients (API) and manufacturing outside the United States and dependence on contract manufacturing organisations and other third-party vendors located outside the United States. Even in the absence of a pandemic, medical product shortages occur for a variety of reasons, including quality issues and various other supply chain-related delays. The full impact of COVID-19 is yet to be realised.
Notably, the consequences of supply chain interruptions from a compliance perspective vary slightly, depending on the type of product and its indication. Human drug products and medical device products have different requirements for reporting supply chain disruptions and the impact of COVID-19 has cast a bright light on this inequity. Compliance with reporting requirements is therefore paramount during the ongoing pandemic.
The Federal Food Drug and Cosmetic Act (FDCA) requires manufacturers of drug products that are life supporting, life sustaining or intended for use in the prevention or treatment of a debilitating disease or condition that is not a radio pharmaceutical, including any such drug used in emergency medical care or during surgery, to report supply chain disruptions at least six months prior to the interruption, or if not possible, as soon as practicable.
As is the case with some drug products, medical devices can be life supporting and life sustaining, posing a risk to public health if essential care for patients is disrupted. No similar reporting requirements for shortages of medical device products exist. Nevertheless, the FDA advises medical device or supply manufacturers to report shortages to the Centre for Devices and Radiological Health (CDRH). The CDRH also tracks shortages and supply issues for such products. Manufacturers are encouraged to respond to the FDA's requests about potential supply chain disruption to allow the agency to take steps to support awareness of potential disruptions to accessing critical medical products. Medical device manufacturers may report potential supply chain disruptions to the FDA's device shortages mailbox at email@example.com.
As early as late January 2020, the FDA began reaching out to manufacturers to remind them of their legal reporting requirements for anticipated supply chain disruptions in light of COVID-19. Because all APIs, certain raw materials, excipients, components of medical devices and finished products must be manufactured in FDA-approved and inspected facilities, identifying an alternative supplier and scaling up for inspection and approval is complicated. In many cases, a supplier of APIs or other components may be single or limited source.
Initially, the FDA asked manufacturers to direct their supply chain inquiry to APIs and other components manufactured in China. This advisory was borne out of the FDA's identification in late February 2020 of nearly 20 drug products with ingredients sourced from China, where COVID-19 severely affected production. However, with the rapid spread of COVID-19, supply chain disruption concerns are no longer limited to China, but have expanded globally. In fact, India's recent curtailment of the export of 26 APIs may continue to increase vulnerabilities in manufacturers' supply chains.
Manufacturers typically forecast their supply through firm forecasting for a certain period (generally 12 months, depending on the drug product) and distributors have certain limitations on the amount of products that they can hold in their warehouses. Distributors play a key role in the supply chain and can assist manufacturers in carefully assessing the demand for medical products. Given the rapid spread of COVID-19 and its impact on the industry, it is anticipated that manufacturers' ability to provide advance notice of supply chain disruption may be significantly hampered.
The FDA maintains a list of drug shortages at 'www.accessdata.fda.gov/scripts/drugshortages'.
Congress deployed significant and extensive countermeasures in passing the Coronavirus Aid, Relief and Economic Security Act (CARES) Act on 27 March 2020. Urgently signed into federal law the same day, the act addresses a wide variety of issues, including drug and medical device shortage. The act amended the FDCA in order to further mitigate drug shortages and prevent medical device shortages.
The FDCA was amended to require that manufacturers of devices that are deemed critical to public health during a public health emergency – including devices that are life supporting or intended for use in emergency medical care or surgery or for which it is determined that information on potential meaningful supply disruptions is needed during or in advance of a public health emergency – must provide notice of:
The CARES Act now requires the secretary of the Department of Health and Human Services not only to expedite, but also prioritise the review of drug applications or supplements to such applications that could help to mitigate or prevent shortages and the inspection or reinspection of an establishment that could help mitigate or prevent a drug shortage (Section 3111).
The FDCA was amended to require that manufacturers provide the FDA with advance notice of a shortage of any drug that is deemed critical to the public health during a public health emergency or any discontinuation or interruption in the supply of such drugs or their active pharmaceutical ingredients (Section 3112).
For further information on this topic please contact Veleka Peeples-Dyer or Khelin N Aiken at Baker McKenzie by telephone (+1 202 452 7000) or email (firstname.lastname@example.org or email@example.com). The Baker McKenzie website can be accessed at www.bakermckenzie.com.
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