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Jill Wechsler discusses the hot topic of how FDA should oversee combination products that incorporate a digital health component.
A growing volume of combination products, particularly for cutting-edge gene and cellular therapies and other new medical technologies, is creating challenges for FDA’s Office of Combination Products (OCP) and its role in advising on whether a new combination therapy should be designated as a drug, biologic, or device. OCP receives hundreds of inquiries on issues related to product classification, many seeking early advice on the regulatory designation process that determines which FDA Center serves as the regulatory lead. Combination products are proliferating as biopharma companies develop innovative products that incorporate prefilled syringes and autoinjectors to ensure the reliable and accurate delivery and dosing for many complex therapies.
FDA officials emphasized the importance of achieving consistency throughout the agency on oversight for multi-component products at a conference sponsored by the Drug Information Association (DIA) in October. Provisions in the 21st Century Cures Act and the FDA Reauthorization Act (FDARA) aim to bolster OCP’s functions and expand its staff to better oversee industry development programs involving combos. Legislative initiatives further support efforts to update proposed guidances and to publish additional advisories on labeling issues and bridging studies, among others topics.
Experts from FDA and industry noted the importance of establishing and evaluating device design controls early in product development to ensure compatibility of the components, as drug viscosity may affect syringe design, and inhalation devices need to efficiently dispense a lung treatment. Human factors testing increasingly is required by FDA to ensure appropriate dosing and drug delivery and avoid medication errors and patient harm. FDA published a draft guidance in Feb. 2016 on human factors studies for combination products [see https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM484345.pdf ] and is reviewing comments to finalize the policy.
A hot topic is how FDA should oversee combination products that incorporate a digital health component, such as a mobile medical app or software to monitor dosing with an antoinjector. FDA’s Center for Devices and Radiological Health (CDRH) has been identifying software functions that don’t warrant regulation as devices, such as wellness support programs, electronic patient records, and clinical decision tools. FDA distinguishes these from software or technology that is part of a drug-based combination product and thus requires pre-market review and approval. FDA has issued guidance on the issue and a Digital Health Innovation Action Plan to provide clarity for manufacturers on appropriate oversight procedures for this fast-changing field, and all parties emphasize the need for a consistent approach for reviewing and providing premarket approval of those digital health products that fall under FDA’s purview.
Strategies for complying with good manufacturing practices (GMPs) also are important in developing combination products. The subject is complex due to differing rules on quality manufacturing for drug and device components and the need for sponsors of drug-based combos to understand and comply with the human factor study requirements more familiar to device makers. FDA has been working to explain and streamline the process for meeting quality standards for both components, as seen in guidance that was finalized in January 2017, and further clarification of the process is due next year. FDA officials say they’re open to considering alternative proposals from manufacturers to meeting GMPs and advise firms to spell out in submissions how multiple facilities will comply with standards.