Califf Confident Public Trust In US FDA Will Be Rebuilt
Executive Summary
Commissioner nominee strikes an optimistic note as former FDA heads raise concerns about the decrease in agency credibility during the pandemic.
US FDA Commissioner nominee Robert Califf struck a positive tone about the impact of potentially his and subsequent administrations, stating that in five years public trust in the agency will be restored.
Controversial decisions and political meddling during the coronavirus pandemic have sown doubt about the decisions from the US Food and Drug Administration, but Califf spoke confidently about the problem during a 9 January appearance at the 2022 Innovations in Regulatory Science Summit.
“Three to five years from now, we will have rebuilt public trust,” he said when asked what we can expect from the FDA during that time. “Remembering that mistrust is a growth factor for misinformation, I think we got to aggressively attack that and I think we will.”
The appearance was rare for a commissioner nominee, and he admitted multiple times during several conference sessions that he could not answer questions candidly while he awaited Senate confirmation.
His optimistic statement about public trust also was not followed by details on how he intended to achieve the aspiration. However, the attention he paid to it may illustrate that the issue will be a high priority should he be given a second term as FDA leader.
Califf’s vision for the upcoming years also included expanded Internet connectivity and improved nutrition.
“Five years from now we should have a population that is much more trusting, living in a digital environment that's supported by broadband everywhere and eating better,” he said.
FDA credibility problems grew in part because Presidents Trump and Biden have been seen as interfering with the FDA’s independence and science-based decision-making (Also see "Biden’s Trump Moment? COVID Booster Messaging Complicated After Top FDA Scientists Raise Doubts" - Pink Sheet, 13 Sep, 2021.), which combined with misinformation and conspiracy theories on social media increased COVID-19 vaccine hesitancy. (Also see "US FDA Finds There’s No Vaccine Against Politics" - Pink Sheet, 13 Dec, 2020.)
More recently, several Senators called for the agency to remove references to race and ethnicity from the provider fact sheets of several COVID-19 treatments, arguing they promote racist decision-making. Data suggests that some minority groups are more likely to be hospitalized or die from COVID-19 than Whites. (Also see "Culture Wars Reach Labeling For COVID-19 Treatments" - Pink Sheet, 17 Jan, 2022.)
Califf served as commissioner for almost a year at the end of President Obama’s term and subsequently worked for Google’s health care firm Verily. His re-confirmation to be Biden’s head of FDA, though, is facing a tough road in the Senate, with anti-abortion groups targeting him in response to the agency’s decision to ease restrictions on abortion pill access. (Also see "Califf Clears First Senate Hurdle, But FDA Abortion Pill Decision May Complicate Final Confirmation" - Pink Sheet, 13 Jan, 2022.)
Increased Skepticism, Regulation Could Affect FDA
Multiple former commissioners who appeared with Califf on the panel about the future of the FDA raised public trust as an ongoing and difficult challenge.
Former Commissioner Scott Gottlieb said continued questioning of FDA or other public health decisions will increase the desire to regulate those activities. As a result, the agency’s work could be made much harder.
“I think this is going to bleed over into the FDA realm in part around the interactions that the agency has with the constituencies that it needs to engage with to do its work effectively,” he said. “We all understand the importance of engagement with the scientific process. I think that’s going to be something that’s going to be challenged in the broader community and we're going to need to make the case for that.”
Acting Commissioner Janet Woodcock also pointed out that the polarization of American society is contributing to the criticism of the FDA.
“The factures in our society are becoming greater and so regulatory is one of the flashpoints,” Woodcock said. “These currents in society make it extremely difficult to chart some kind of course that is a reasonable consensus path forward.”
Former Commissioner Margaret Hamburg said the FDA has to act in a way that will engender confidence in decisions.
“FDA has to really demonstrate its trustworthiness,” she said. “I think really talking as much as possible about what FDA does, how it does it and why is crucial for policymakers and the public to understand.”
Stakeholders have argued that the agency should change its communications strategy to improve transparency and understanding, as well as fight misinformation related to its decisions. (Also see "US FDA Communication Ahead Of Major Actions Could Counter Misinformation, Ex-Official Says" - Pink Sheet, 29 Nov, 2021.)
Staff Morale Also Needs Attention, Hamburg Says
Hamburg also raised one of the consequences of the eroding public trust in the agency, staff morale, as another ongoing problem.
Woodcock and other FDA officials have repeatedly acknowledged that the FDA staff is exhausted after working on pandemic issues in addition to their traditional duties for more than two years.
The COVID-19 pandemic has increased attrition and made recruitment more challenging at the FDA. The agency had to scale-back its staffing expectations in fiscal year 2022, which required it to lower prescription drug user fees. (Also see "US FDA Lowers FY '22 PDUFA Fees Due to Hiring, Attrition Concerns" - Pink Sheet, 13 Aug, 2021.)
Senior leaders also have implored staff to take time away in order to avoid burn-out. (Also see "CBER’s ‘Courageous’ Coronavirus Guidance Strategy May Catch-On" - Pink Sheet, 25 Jun, 2020.)