COMPLIANCE AND ENFORCEMENT OF FDA-REGULATED PRODUCTS
CD: Across the product lifecycle – from clinical trials and the pre-market review process through to post-market compliance – what general steps does a US Food & Drug Administration (FDA) compliance strategy need to include?
Mikson: The precise issues and steps to be taken regarding Food and Drug Administration (FDA) regulatory compliance vary at each of the different stages of the product lifecycle. However, there are general strategies and priorities that are common to most, if not all stages of the product lifecycle. At the outset, the sponsor must have a clear and thorough understanding of FDA regulations, guidance and practices in the therapeutic area at issue that will be applicable at each point in the process. For example, drugs in the oncology area may have particular clinical trial standards applicable because of the nature of the disease and patient populations, which may include an enhanced ability to utilise adaptive clinical trial design and possibly real-world evidence. As the process moves forward, the sponsor needs to be prepared to engage the FDA ‘early and often’, and to be proactive in taking advantage of informational meetings and more substantive meetings that are available throughout the ongoing development, testing and approval processes. Finally, at a high level the sponsor should take care to assess and implement a plan for coordinating the FDA strategy with other critical areas such as intellectual property (IP) and reimbursement. To that end, parties must ensure that the FDA’s lawyers and consultants, the patent lawyers and the reimbursement experts are all talking to each other and are working together from the very beginning of the product lifecycle.
Jan-Mar 2020 issue
Mayer Brown LLP
Shook, Hardy & Bacon L.L.P.