Over the past few weeks, the FDA has continued to focus its attention on supply chain issues. The agency has released draft guidance on the expectations of its supply chain business partner verification system for prescription drugs and a draft of what manufacturers can expect in changes to drug fees. Device Use (MDUFA V) 2023. The Center for Devices and Radiological Health (CDRH) has released a fact sheet to inform the public of its plans to prevent future medical device shortages. The FDA has submitted its 2023 budget to Congress. In a similar vein, the FDA updated its device shortage and discontinuation list and sent a letter to medical personnel detailing retention strategies. Representatives Mike Gallagher (R-WI) and Mark Pocan (D-WI) introduced a bill in an effort to strengthen the supply chain for medical products. In other developments, investments continue to be made in cold chain monitoring as consumer lifestyles and habits change. Please see details of these and other supply chain developments below:
- On March 10, the FDA released draft guidance on agency expectations of drug supply chain business partners, “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” These follow-up guidelines clarify the expectations of manufacturers, repackers, wholesale distributors and dispensers to prepare for the implementation of Section 202 of the Security of the Medicines Supply Chain Act of 2013. Specifically, the draft guidance focuses on expectations of system requirements and what system activities it expects to see from each supply chain trading partner. Emphasis is placed on what is necessary to ensure adequate assessment processes for suspect and illegitimate products to either release them to market or safely remove them from the supply chain to prevent future distribution.
- On March 17, the FDA released a fact sheet, “Mitigate and Prevent Medical Device Shortages and Prioritize Public Health,” designed to inform the public of the steps CDRH is taking to prevent future device shortages. devices. Under the authority granted by the CARES Act, the FDA worked with manufacturers and other entities to expedite the review of device submissions and address supply chain vulnerabilities. Going forward, the FDA is seeking legislation requiring manufacturers to notify the agency of impending shortages, whether or not a public health emergency exists.
- On March 21, the FDA added 0.9% sodium chloride IV lock/flush prefilled syringes (product code NGT – saline, vascular access flush) to the list of missing devices and the list of abandonment of devices. The FDA issued a letter to healthcare personnel to provide recommendations, including storage strategies, for syringes. The FDA has also added certain discontinued surgical garments (product codes FME, FXP, FYF, LYU, and OEA) to the device discontinuation list.
- On March 23, the FDA released the draft MDUFA V 2023, which outlines the responsibilities FDA commits to for manufacturers of medical products that require oversight. The agency plans to hire additional staff to facilitate compliance. Timelines attempt to manage expectations of increased submissions by providing timelines in which the agency will respond with the appropriate next step. The shared results objectives are:
- Average total decision time for premarket approval submissions and panel pathway supplements of 290 and 285 calendar days for fiscal year 2023-2024 and for years 2025-2027, respectively.
- For 510(k) submissions, the shared outcome targets are total decision time of 118 days for fiscal year 2023, 124 days for fiscal year 2024, and 112 days for years 2025-2027.
- The FDA will also continue the Q-Submission program, which allows for pre-submission meetings with the agency for feedback. The FDA commits to a maximum response time of 15 calendar days for acceptability and 70 calendar days (or five before a meeting) for written comments.
The terms of the agreement ask the FDA to commit to 90% timeliness for pre-submissions for FY2023 if the cohort is below 3,585 and 75% if the cohort is above (up to 4,300). For fiscal year 2024, the commitment is 90% for less than 4,060 and 80% for more (up to 4,300). For the years 2025 to 2027, the engagement target is 90% for a maximum of 4,300 pre-submissions. The specific objectives of the agency are stated in the letter.
- On March 24, Rep. Mike Gallagher (R-WI), with Rep. Mark Pocan (D-WI) as a 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 manufacturers to provide additional reporting on the supply and composition of drugs and medical devices and potential and impending shortages and allow expedited review of devices that traditionally require approval. prior to marketing. Manufacturers may be concerned about additional requirements that may increase the regulatory burden; however, the potential trade-off is the ability to more effectively market potential products considered life-saving. The bill was referred to the Energy and Commerce Committee.
- On March 28, the FDA released its 2023 budget request to Congress. The application’s priorities indicate that the agency wants to increase its oversight power and is looking for ways to become more effective. Specifically, the FDA wants to require manufacturers to participate in remote interactive assessments and wants greater oversight to implement cybersecurity measures on devices, remove products from the market when no confirmatory data has been produced, removing barriers to competing generic drug approvals, overseeing dietary supplement ingredient lists, extending expiry dates for pharmaceutical products in the event of shortages, and ordering the destruction of imported products and payment for the action of destruction by manufacturers. The request also includes some elements relating to drug shortages. The agency is asking for the ability to require companies to report when a shortage of medical devices is expected and also to require companies to conduct risk assessments of their supply chain. It is expected that not all applications will be approved; however, they could be included in future legislation.
- The FDA has released its FY 2021 Medical Countermeasures Initiative (MCMi) program update. The objective of the program is to promote “the development of and access to safe and effective MCMs”. For fiscal year 2021, approximately 470 EUAs were issued for approximately 750 products. The agency has also approved, licensed, or cleared more than 1,000 generic drugs and about 500 PPE products. Additionally, in a signal that it intends to vigorously exercise its oversight authority, the FDA has identified approximately 1,500 fraudulent products. As a result, 260 warning letters were sent and 393 fraudulent test kits were reported. For this effort, the agency advises its partners in fiscal year 2021 that it has exercised its authority to “advance the FDA’s capabilities to monitor the MCM supply chain to identify product shortages and distribution of mislabelled/counterfeit products”.
- Companies have implemented their own solutions for disruptions in the pharmaceutical supply chain. Three companies, Swoop Aero, Skyports and BD Rowa, have joined efforts to develop drone delivery systems for pharmaceuticals using healthcare technology solutions. Drone companies, Swoop Aero and Skyports, will provide the drone infrastructure. Swoop Aero has extensive mapping and video technology, and Skyports is developing vertiports for drone activities. BD Rowa will bring its automated technology to healthcare. The hope is that this joint venture can help eliminate touch points in the supply chain and improve efficiency and access to pharmaceuticals.
- Consumption and consumer needs, including pharmaceuticals and farm-to-fork food trends, are driving the 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 United States and China, as companies invest in facilities and emerging technologies for their products. Growth is also visible in the Asia-Pacific region. With the expected growth, this is a business opportunity for manufacturers of software applications and hardware devices to grow and expand to meet incoming needs worldwide.