More Uncertainty and Less Advice from FDA Means Companies will Need to Even More Carefully Chart their own Course to Achieve their Goals

Trade and national press have reported that recent changes in FDA staffing levels have already led to  slower responses to calls and emails.  According to reports, which were published before the most recent reports of HHS staff level reductions and tumultuous changes in leadership, FDA staff were missing minor deadlines.  This coupled with more recent reports raised the specter of FDA falling short of user fee goals.

Although reviews teams’ workload has not decreased, resources have. FDA leadership will inevitably need to make some difficult choices, including internal guidance on which assignments teams should prioritize and which can be temporarily or indefinitely delayed, or completely shelved.

A less robust schedule of external meetings and slower pace of publications of Guidance to Industry may further slow communication to sponsors who eagerly await information critical to inform their development programs.

While it may be hard to see the upside to less information from FDA, Albert Einstein famously stated, “In the middle of difficulty lies opportunity.”  As FDA itself navigates through turbulent times, companies will need to anticipate potential issues with what may be less direct, thorough, and prompt feedback from FDA. Just as important will be the need to respond expertly, efficiently and meaningfully to FDA concerns. Therein lies the opportunity.

While much may be in flux, the central tenet of drug development remains the same, develop drugs that are safe and effective drugs for patients, through streamlined, efficient, and cost-effective development programs. Key to achieving those goals is the ability to anticipate FDA feedback and concerns.

As we continue to closely follow inevitable additional changes, sponsors should consider how to best anticipate and adapt. Patients and their families are counting on it.