Top Ten Challenges Facing FDA
Top Ten Challenges Facing FDA
Alliance board member and co-founder, Wayne Pines invited me to appear on a panel sponsored by FDA News, entitled “FDA in 2023: A Look Ahead at Achievements, Priorities, and Budget.” I was pleased to share the podium with Nancy Myers, also an Alliance board member and Alliance co-founder.
As part of the presentation, I laid out ten challenges facing FDA. These seemed worth sharing:
FDA responsibilities are growing faster than the budget. The Alliance is grateful for the support the agency has received from both the House and Senate Appropriations Committees. Despite that, the agency’s responsibilities have grown far faster than its funding.
Larger investment in information technology (IT) and information management (IM) is essential to maintaining the agency’s “gold standard. It's challenging to find the resources, but even harder to create new systems that integrate seamlessly and add value for regulatory decisionmakers and sponsors. Nonetheless, there has been much progress.
Commissioners’ tenures are too short. From a human resources perspective, there is not much that can be done about this. The challenge to the agency: find new and better ways of maintaining continuity.
Difficulty of recruiting and retaining a scientific workforce. This will be addressed at an Alliance webinar on June 5 with FDA Chief of Staff Julie Tierney.
Maintaining public credibility and support for the agency’s role as a government agency. The last half-dozen years have eroded support for government, its agencies, and spokespersons.
Establishing FDA exceptionalism. When hard resource decisions are made, policymakers need to fully appreciate the benefits of a well-resourced FDA. I discussed this more fully here. The article begins: “In a town full of special interests, it takes a certain moxie to claim that your interest represents needs that are uniquely important.”
Staying ahead of transformative technologies. FDA faces a wave of new technologies with broad implications for FDA-regulated products. Gene and cell therapy is finally coming into its own…and requiring a large investment of money and specialty personnel. Digital health has the same potential. We don’t know how consequential others will be, such as AI, block chain, and whole genome sequencing.
Agency support for innovation in medical products and food safety. FDA support for innovation requires the right rules and tools and the judicious application of them. Debate about accelerated approval reflects the potential for differing views.
Maintaining public credibility and support for scientific decision-making. Governmental institutions are generally experiencing a loss of public credibility (as discussed above). For FDA, the threat is greater and more specific: the undermining of scientific decision-making. Science is often not definitive, but it is still not “just another opinion.”
Sustain commitment to safety (the foundation of innovation has to be safety!). I think this speaks for itself. If not, I recommend this 2005 article on how development of cell and gene therapy suffered setbacks because of safety problems.
Email me (Sgrossman@strengthenfda.org) if you would like the entire slide deck from this presentation.
Editorial Note:
The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.