FDA Commissioner Robert Califf said he had asked the foundation to conduct an independent review of its offices in July, amid lawmakers and public outcry over the agency’s actions against infant formula shortages and delayed regulation of electronic cigarettes. .
Henney was the first woman to lead the FDA and serve in the Clinton administration. She serves on the audit and compliance committee of the Commonwealth Fund’s Healthcare Policy Foundation and serves on the board of directors of AmerisourceBergen, a wholesaler of pharmaceuticals. She could not be reached for comment at the time of publication.
Former agency and regulatory experts are skeptical about whether this review will lead to meaningful change at the agency, in part because of Reagan-Udall’s ties to the FDA and industry.
“I expect they’ll make some kind of low-hanging fruit recommendations,” said a former senior FDA official, who was granted anonymity to speak candidly on the matter. “Anytime you have someone affiliated with the FDA, even including Dr. Henney, you probably have a preference for low-hanging fruit.”
The recent infant formula crisis has tightened oversight of the agency’s food safety department. Contaminated bottle feeding led to multiple infant deaths earlier this year and contributed to severe shortages for months. Many outsiders had questions about how the FDA hadn’t taken action against formula factories with unsanitary conditions for so long, and a POLITICO investigation revealed a four-month delay between the first reports of contamination and a follow-up inspection.
“The agency’s inspection activities related to the program should also be reviewed, especially in light of the tensions related to the Covid-19 pandemic,” Califf said in a statement on the review. “The agency has faced a series of challenges that have tested our regulatory frameworks and highlighted the agency’s activities, prompting me to take a closer look at the way we do business.”
The Reagan-Udall Foundation was… made by Congress under the 2007 User Fee Amendment Package. Lawmakers have chartered it to further the FDA’s mission while remaining independent of the federal government. It relies on funding from the agency, the food and pharmaceutical industry, grants, contracts, and private donors.
“This study is exactly what Reagan-Udall was created for,” Ellen Sigal, chair of the foundation’s board of directors, said in an emailed statement to POLITICO. “I am confident that we will provide a useful report to the FDA and that the process will be robust, independent and transparent once underway.”
The foundation maintains close ties to the agency and the sectors it regulates. Susan Winckler, director of Reagan-Udall, was previously the FDA chief of staff. Mark McClellan and Andrew von Eschenbach, both former FDA commissioners, serve on the foundation’s board of directors.
In 2021, Reagan-Udall received $1.25 million in operational funding from the FDA. Major pharmaceutical companies, including Pfizer, AbbVie, Eli Lilly and Janssen, are among the project financiers, as are food giants Kellogg and Nestlé USA.
“Reagan-Udall will be aligned with Califf,” said another former senior FDA official familiar with the matter. He was also given anonymity to speak candidly. “This is an attempt to make him [Califf] some breathing room to let him make some decisions about how he’s going to organize these offices in the future.”
“We are a nonprofit, non-governmental organization with one purpose and that is to help the FDA do more to protect and advance public health,” said Winckler of Reagan-Udall. That will require some involvement from outside stakeholders and interaction with the FDA, she added.
“We will continue to structure our work in an independent way and that is how we will deliver the work here too,” she says.
Winckler said the foundation’s investigation will yield two basic reports focused on the activities of each of the divisions under criticism. Each report is led by its own advisors. The foundation will also set up a web portal where FDA employees can anonymously voice their concerns.
“This will not be a treatise, but it will be substantive,” Winckler said.
Regulatory experts noted that while Reagan-Udall could lead a fair assessment of the agency, transparency will be key to earning the trust of the public and lawmakers. “It is absolutely essential that the reports [are] considered credible,” said Wayne Pines, former FDA associate commissioner and president of healthcare at APCO Worldwide, a management consulting firm.
He added that while he believed the foundation would be able to conduct a thorough evaluation of the agency’s offices — especially given the experiential knowledge of the foundation’s staff — he understands the financial ties to the agency. agency and the sectors it regulates may skew its assessment.
“I think there is reason for us to be cautiously optimistic about the process they will use to conduct this review, both in terms of transparency and in terms of stakeholders,” said Brian Ronholm, the director of food policy at Consumer Reports and former Deputy Undersecretary for Food Safety at the United States Department of Agriculture.
But advocacy groups say they are concerned that Reagan-Udall’s ties to the industry and the agency make it impossible for the foundation to conduct an objective assessment.
“There’s a direct and obvious contract conflict of interest there,” said Michael Carome, the director of the health research group at Public Citizen, a consumer advocacy group. “What is really needed is a [Government Accountability Office] research that would clearly be completely independent or a [inspector general] research.”