January 1, 2024

A New Way for FDA

My interactions with the California Department of Motor Vehicles – the dreaded DMV – have been increasingly hassle-free and efficient recently, even with some complicated transactions. Maybe it was just luck, but it feels like real change has taken hold in the DMV. Could it be that the person appointed by Gov. Gavin Newsom in 2019 to modernize and improve this calcified bureaucracy – a Silicon Valley entrepreneur named Steve Gordon – has made real reform a reality?

I doubt that the relatively new Commissioner of the U.S. Food and Drug Administration (FDA) would appreciate the DMV comparison, because the scope and responsibilities of the FDA are entirely different. But there are some significant parallels.

Dr. Robert Califf was confirmed as the new Commissioner of the FDA in early 2022, following a close Senate vote. Having served as Commissioner once before – for about one year during the Obama Administration – one might wonder what could possibly motivate a highly accomplished cardiologist in his early seventies to return to lead a public agency beset by controversy and criticism from voices across the spectrum.

Almost immediately, Dr. Califf requested an independent analysis of the FDA’s Human Foods Program (HFP) from the respected Reagan-Udall Foundation for the FDA. Implicit in his request was an admission that the agency’s convoluted structure and perhaps its culture were failing to enhance the safety of America’s food supply even as the ability to detect the presence of pathogens in fresh produce and other food items has dramatically increased with technology advances.

The report – labeled an “operational evaluation” – was clear and compelling in urging a reform of FDA’s Human Foods Program, beginning with an unsurprising call for additional funding for “the best technology, staff, and unrivaled infrastructure to advance its mission.” Beyond resources, the panel pointedly observed that the Food Safety Modernization Act (2011) “was meant to move food safety towards prevention rather than reaction but making the regulatory paradigm shift envisioned has yet to be realized.” The panel called out cultural deficiencies and diffused decision-making authority that undermine the needed shift from an enforcement-first approach to food safety to one that emphasizes collaboration, both internally and with industry, to facilitate the shift to a more effective focus on prevention.

For some FDA veterans, much of the content of the Reagan-Udall report had to be tough to read, and that’s where I think things could get interesting. Bureaucracies are notoriously resistant to change, especially when that change is seen as being imposed by the political appointees at the top of their organizational chart. Having worked for seven years as a political appointee of a large state agency (the California Attorney General’s Office), I saw firsthand the myriad ways public employees, shielded by civil service laws, could thwart the policies and directives of the person elected by the voters to lead that agency.

I have no way of knowing whether the reform outline suggested by Reagan-Udall, or at least those elements now embraced by Commissioner Califf, will be thwarted by recalcitrant FDA employees. It certainly helps that Califf has a broad coalition of interests backing him up. Western Growers has been collaborating for about a year with an odd-bedfellows coalition of organizations that have aligned on this FDA reform agenda, ranging from consumer, environmental and food safety groups to industry associations.

By all accounts, Califf is committed to reform and has clarity as to what a prevention approach to food safety could deliver: A constantly improving and safer food supply based on collaboration and trust between the regulators and the regulated. The recent appointment of Jim Jones as FDA Deputy Commissioner for Human Foods appears to confirm Califf’s seriousness about this. Jones, a 30-year veteran of the U.S. EPA, served on the Reagan-Udall expert panel, and has already travelled to Salinas to meet with industry members.

Many have pointed to the example of the airline industry. In the 1990s, the industry began a collaboration with the Federal Aviation Administration to evolve from enforcement-first to transparent data sharing and system-wide safety improvements that dramatically reduced airline safety incidents. Tim York, CEO of the California Leafy Greens Marketing Agreement, has been an especially effective advocate for a version of that model.

In a meeting last year, Califf pointed to a slightly different example. As a young pioneer in open heart surgeries, Califf witnessed incredibly rapid improvements in health outcomes following open heart surgeries thanks to an information and data sharing model that the medical industry and its regulators adopted in the 1970s. As a relatively new and risky procedure, there was much to learn from every adverse experience, and the rapid and transparent sharing of those experiences, with a no-blame framework (excepting for negligence) among cardiologists, researchers and public health authorities, led to rapid improvements in open heart surgery techniques and patient outcomes.

The stakes are similarly high this time, as the fresh produce industry and the FDA together face the difficult challenge of further reducing the incidences of foodborne illness outbreaks.

Turning a ship as big and unwieldy as the FDA won’t be easy but for the sake of consumers and every aspect of the fresh produce supply chain, we need to help Robert Califf succeed. If the California DMV can be reformed, anything is possible.