By Claire Davies, Shareholder, Polsinelli (Special Guest Contributor)
Life sciences companies are constantly innovating with the goal of developing groundbreaking medical products. Unfortunately, the most novel products often face more uncertainty about their regulatory pathway to market—with several factors heightening that uncertainty today. These include the loss of many FDA policy and scientific staff over the past six months and multiple changes in leadership, such as at the head of the agency’s drug and biologics programs. Although significant personnel change may present opportunities for companies that would benefit from a change in the agency’s historic regulatory approach, it also unsettles precedent for the FDA’s expectations. In addition, as numerous companies explore applications of generative AI, the agency itself has indicated that generative AI-enabled products present challenges to existing (often decades old) laws that govern FDA’s regulatory framework.
With these factors in play, companies may be tempted to hold off on spending resources to map out their regulatory strategy and get feedback from the agency. But incorporating regulatory considerations into early business plans remains key for a number of reasons:
- Efficient Product Development: Whether and how FDA will regulate your product determines the level of evidence and type of application needed to enter the market. (Does your AI-enabled product fall within an exception from regulation as a medical device? If not, it may require an FDA application supported by significant data.) An early understanding of the regulatory pathway can help companies budget development costs more accurately. It can also help them anticipate and proactively address regulatory hurdles, ultimately shortening the time it takes to get the product to market.
- Raising capital: Regardless of scientific promise, companies that underestimate the regulatory complexity of getting a medical product to market or that lack an experienced in-house or external advisory team in this area may be viewed as a risky proposition for investors. In contrast, a thorough understanding of the regulatory pathway and plan for navigating the challenges to commercialization can help distinguish a company from the crowd.
Ultimately, an early and proactive approach to your regulatory strategy is a critical investment that can help shorten time to market and increase your company’s attractiveness to investors.
Claire Davies is a Shareholder in Polsinelli’s FDA practice where she provides strategic counsel to help clients navigate FDA regulatory and compliance challenges. Claire has handled a wide range of issues involving medical devices, biological products, drugs and human cells, tissues and cellular and tissue-based products (HCT/Ps). Prior to joining Polsinelli, Claire spent nearly a decade as an attorney in the FDA’s Office of the Chief Counsel. Her work at FDA often involved advising agency leadership on high-profile and significant matters, such as responses to emerging public health threats and user fee negotiations with industry.
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