In the past few weeks, the FDA has continued to focus its attention on supply chain issues. The agency published draft guidance on its verification system expectations of supply chain trading partners for prescription drugs and a draft of what manufacturers can expect in the Medical Device User Fee Amendments (MDUFA V) 2023. The Center for Devices and Radiological Health (CDRH) issued a fact sheet to inform the public of its plans to prevent future medical device shortages. The FDA submitted its 2023 budget to Congress. Relatedly, the FDA updated its device shortage and discontinuance list and issued a letter to medical care personnel detailing conservation strategies. Representatives Mike Gallagher (R-WI) and Mark Pocan (D-WI) introduced a bill with the goal of strengthening the medical products supply chain. In other developments, investments continue to be made in cold chain monitoring as consumers’ lifestyles and habits change. Please see details for these and other supply chain developments below:
- On March 10, the FDA published draft guidance on the agency’s expectations of trading partners in the drug supply chain, “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” This follow-up guidance clarifies expectations of manufacturers, repackagers, wholesale distributors, and dispensers to prepare for the implementation of Section 202 of the Drug Supply Chain Security Act of 2013. Specifically, the draft guidance focuses on the expectations of system requirements and what particular system activities it expects to see from each trading partner in the supply chain. The focus is what is necessary to ensure adequate evaluation processes of suspect and illegitimate products to either render them saleable or safely removed from the supply chain to avoid future distribution.
- On March 17, the FDA published a fact sheet, “Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health,” designed to inform the public of the steps the CDRH is taking to prevent future device shortages. Under the authority granted by the CARES Act, the FDA collaborated with manufacturers and other entities to expedite review of device submissions and address supply chain vulnerabilities. Going forward, the FDA is requesting legislation to require manufacturers to inform the agency of impending shortages regardless of whether a public health emergency exists.
- On March 21, the FDA added prefilled 0.9% sodium chloride IV lock/flush syringes (product code NGT – Saline, Vascular Access Flush) to the device shortage list and the device discontinuance list. The FDA issued a Letter to Health Care Personnel to provide recommendations, including conservation strategies, for the syringes. The FDA also added certain discontinued surgical apparel (product codes FME, FXP, FYF, LYU, and OEA) to the device discontinuance list.
- On March 23, the FDA released the draft MDUFA V 2023, which outlines the responsibilities the FDA agrees to abide by for manufacturers of medical products that require oversight. The agency expects to hire additional personnel to aid compliance. The timelines attempt to manage expectations for increases in submissions by providing deadlines by which the agency will respond with the appropriate next step. The shared outcome goals are:
- Average total time to decision for premarket approval submissions and panel track supplements of 290 and 285 calendar days for FY 2023–2024 and for years 2025–2027, respectively.
- For 510(k) submissions, the shared outcome goals are total time to decision goals of 118 days for FY 2023, 124 days for FY 2024, and 112 days for years 2025–2027.
- The FDA will also continue the Q-Submission program, which allows pre-submission meetings with the agency for feedback. The FDA is committing to a maximum response time of 15 calendar days for acceptability and 70 calendar days (or five before a meeting) for written feedback.
The terms of the agreement call for the FDA to commit to 90% timeliness for pre-submissions for FY 2023 if the cohort is less than 3,585 and 75% if the cohort is greater (up to 4,300). For FY 2024, the commitment is 90% for less than 4,060 and 80% for greater (up to 4,300). For years 2025–2027, the commitment goal is 90% for up to 4,300 pre-submissions. Specific agency goals are indicated in the letter.
- On March 24, Rep. Mike Gallagher (R-WI), with Rep. Mark Pocan (D-WI) as co-sponsor, introduced HR 7208, the Medical Supply Chain Security Act, which would amend the Federal Food, Drug, and Cosmetic Act. As submitted, this bipartisan bill would require additional reporting by manufacturers on the sourcing and the constitution of medical drugs and devices and potential and imminent shortages and allow for expedited review of devices that traditionally require a premarket approval. Manufacturers may be concerned with the additional requirements that may increase the regulatory burden; however, the potential tradeoff is the ability to bring potential products deemed life-saving to market more efficiently. The bill has been referred to the Committee on Energy and Commerce.
- On March 28, the FDA released to the public its 2023 budget request to Congress. The priorities in the request signal that the agency wants to increase its oversight authority and that it seeks ways to become more efficient. Specifically, the FDA wants to compel manufacturers to participate in remote interactive evaluations and seeks greater oversight to implement cybersecurity measures on devices, remove products from the market when no confirmatory data has been produced, remove barriers to competing generic drug approvals, oversee ingredients listings of dietary supplements, extend expiration dates for drug products during shortages, and order destruction of imported products and the payment of the destruction action by manufacturers. The request also includes a few items relating to drug shortages. The agency is asking for the ability to require companies to report when a medical device shortage is anticipated and also to mandate that companies conduct risk assessments of its supply chain. It is anticipated that not all of the requests will be approved; however, they could be included as a part of future legislation.
- The FDA published its FY 2021 Medical Countermeasures Initiative program (MCMi) update. The goal of the program is to promote “development of and access to safe and effective MCMs.” For FY 2021, approximately 470 EUAs were issued for roughly 750 products. The agency also approved, licensed, or cleared over 1,000 generic drugs and approximately 500 PPE products. Also, in a signal it intends to vigorously exercise its oversight authority, the FDA identified approximately 1,500 fraudulent products. As a result, 260 warning letters were sent and 393 fraudulent test kits were reported. To this effort, the agency is informing its partners in FY 2021 it exercised its authority to “advance FDA capacities to monitor the MCM supply chain to identify product shortages and distribution of misbranded/counterfeit products.”
- Companies have been implementing their own solutions for pharmaceutical supply chain disruptions. Three companies, Swoop Aero, Skyports, and BD Rowa, have joined efforts to develop drone delivery systems of pharmaceutical products by utilizing health care technological solutions. The drone companies, Swoop Aero and Skyports, will provide the drone infrastructure. Swoop Aero has extensive mapping and video technology, and Skyports develops vertiports for drone activities. BD Rowa will contribute its automated technology for health care. The hope is this joint venture can help eliminate touch points in the supply chain and to improve efficiency and access to pharmaceutical products.
- Consumer consumption and needs, including pharmaceutical products and farm-to-fork food trends, are driving demand for global cold chain monitoring, which encompasses the use of software and hardware to monitor refrigeration. It is estimated that by 2026, the market will reach $10.9 billion, driven largely by the US and China, as businesses invest in facilities and emerging technologies for their products. Growth is being seen in the Asia Pacific region as well. With the expected growth, this is a business opportunity for manufacturers of software applications and hardware devices to grow and expand to meet the incoming need around the world.