FDA Commissioner Robert Califf said he asked the foundation to conduct an independent review of the offices in July amid lawmaker and public outcry over the agency’s actions on the infant formula shortage and delayed electronic cigarette regulation.
Henney was the first woman to lead the FDA and served in the Clinton administration. She is a member of the Audit and Compliance committee of the health care policy foundation at the Commonwealth Fund and sits on the board of directors of AmerisourceBergen, a wholesale drug company. 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 due to Reagan-Udall’s ties with the FDA and industry.
“I expect that they’ll give some kind of low-hanging fruit recommendations,” said one former senior FDA official, who was granted anonymity to speak candidly on the matter. “Any time you have someone who is connected to the FDA, even including Dr. Henney, you’re probably going to get some bias toward low-hanging fruit.”
The recent infant formula crisis heightened scrutiny of the agency’s food safety division. Contaminated formula led to multiple infant deaths earlier this year and contributed to severe shortages for many months. Many outsiders had questions as to how the FDA had failed to take action on formula plants with unsanitary conditions for so long, and a POLITICO investigation uncovered a four-month delay between initial reports of contamination and a follow-up inspection.
“The agency’s inspectional activities related to the program also need to be evaluated, particularly in light of stresses related to the Covid-19 pandemic,” Califf said in a statement about the review. “The agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations, prompting me to take a closer look at how we do business.”
The Reagan-Udall Foundation was created by Congress under the 2007 user fee amendment package. Lawmakers chartered it to advance the mission of the FDA while remaining independent from the federal government. It relies on funding from the agency, the food and pharma industries, grants, contracts and private donors.
“This study is exactly what Reagan-Udall was established to do,” 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 helpful report to the FDA and that the process will be robust, independent and transparent once it is underway.”
The foundation maintains close ties to the agency and the industries it regulates. Susan Winckler, Reagan-Udall’s chief executive, previously was the chief of staff for the FDA. 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 drug companies, including Pfizer, AbbVie, Eli Lilly and Janssen are listed among its project funders, as are food giants Kellogg and Nestlé USA.
“Reagan-Udall will be aligned with Califf,” another former senior FDA official familiar with the matter said. He was also granted anonymity to speak candidly. “This is an attempt to give him [Califf] some breathing room to let him make some decisions on how he’s going to organize these offices moving forward.”
“We are a non-profit, non-government organization with one purpose and that’s to help the FDA do more to protect and promote public health,” said Reagan-Udall’s Winckler. That requires some external stakeholder engagement and interaction with the FDA, she added.
“We continue to structure our work in an independent manner and that’s how we will deliver the work here as well,” she said.
Winckler said the foundation’s investigation will create two baseline reports focused on the operations of each of the divisions being critiqued. Each report will be led by its own advisers. The foundation will also be setting up a web portal where FDA staff may anonymously submit 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 review of the agency, transparency will be key to gaining public and lawmaker trust. “It’s absolutely essential that the reports [are] viewed as credible,” said Wayne Pines, a former associate commissioner for the FDA and president of health care at APCO worldwide, a management consulting company.
He added that although he believed the foundation would be able to conduct a solid review of the agency’s offices — especially given the foundation personnel’s experiential knowledge — he understands that its financial ties to the agency and the industries it regulates may appear to bias its assessment.
“I think there’s reason for us to be cautiously optimistic about the process that they’ll be using 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 U.S. Department of Agriculture.
But advocacy groups say they worry that Reagan-Udall’s ties to industry and the agency make it impossible for the foundation to conduct an objective review.
“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’s really needed is a [Government Accountability Office] investigation that clearly would be completely independent or an [inspector general] investigation.”