FDA Commissioner Robert Califf said he asked the foundation to conducted an independent office review in July amid lawmaker and public outcry over the agency’s actions on the shortage of infant formula and delayed e-cigarette regulation.
Henney was the first woman to head the FDA and served in the Clinton administration. She is a member of the Audit and Compliance Committee of the Commonwealth Fund Health Care Policy Foundation and sits on the board of AmerisourceBergen, a wholesale pharmaceutical company. She was not reachable for comment at the time of publication.
Former agency and regulatory experts are skeptical whether this review will lead to meaningful changes within the agency, in part because of Reagan-Udall’s ties to the FDA and industry.
“I expect them to give some sort of handy fruit recommendations,” said a former senior FDA official, who spoke candidly on the matter. “Anytime you have someone who is connected to the FDA, including Dr. Henney, you’re probably going to have a fruit bias at your fingertips.
The recent infant formula crisis has heightened scrutiny from the agency’s food safety division. Contaminated infant formula led to several infant deaths earlier this year and contributed to severe shortages for many months. Many outsiders wondered how the FDA hadn’t taken action against formula factories with unsanitary conditions for so long, and a POLITICO investigation found a four months late between initial reports of contamination and a follow-up inspection.
“The agency’s inspection activities related to the program must also be assessed, particularly in light of the constraints related to the Covid-19 pandemic,” Califf said in a statement on the review. “The agency faced a series of challenges that tested our regulatory frameworks and strained agency operations, prompting me to take a closer look at how we do business. business.”
The Reagan-Udall Foundation was created by Congress as part of the 2007 user fee change package. Legislators chartered it to advance the FDA’s mission while remaining independent of the federal government. It relies on funding from the agency, the food and pharmaceutical industries, grants, contracts and private donors.
“This study is exactly what Reagan-Udall was created to do,” Ellen Sigal, chair of the foundation’s board, said in a statement emailed 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 with the agency and the industries it regulates. Susan Winckler, chief executive of Reagan-Udall, was previously the FDA’s 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 its backers, as are food giants Kellogg and Nestle USA.
“Reagan-Udall will be aligned with Califf,” said another former senior FDA official familiar with the matter. He was also granted anonymity to speak candidly. “It’s an attempt to give him [Califf] some breathing space to allow him to make decisions on how he will organize these offices in the future.
“We are a nonprofit, nongovernmental organization with one goal and that is to help the FDA do more to protect and promote public health,” Winckler of Reagan-Udall said. This requires some engagement from external stakeholders and interaction with the FDA, she added.
“We continue to structure our work independently and that’s how we will do the work here as well,” she said.
Winckler said the foundation’s investigation will create two baseline reports focusing on the operations of each of the criticized divisions. Each report will be led by its own advisors. The foundation will also set up a web portal where FDA staff can submit concerns anonymously.
“It won’t be a treaty, but it will be substantive,” Winckler said.
Regulatory experts noted that while Reagan-Udall could conduct a fair review of the agency, transparency will be key to earning the trust of the public and lawmakers. “It is absolutely essential that the reports [are] as credible,” said Wayne Pines, former associate commissioner of the FDA and president of healthcare at APCO Worldwide, a management consulting firm.
He added that while he believes the foundation would be able to conduct a thorough review of the agency’s offices – particularly given the experiential knowledge of the foundation’s staff – he understands that his financial ties to the agency and the industries it regulates may appear to bias its assessment.
“I think we have reason 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, director of food policy. at Consumer Reports and former Deputy Assistant Secretary for Food Safety at the United States Department of Agriculture.
But advocacy groups say they fear Reagan-Udall’s ties to industry and the agency prevent the foundation from conducting an objective review.
“There is a direct and obvious contractual conflict of interest here,” said Michael Carome, director of the health research group at Public Citizen, a consumer advocacy group. “What is really needed is a [Government Accountability Office] investigation that would clearly be completely independent or a [inspector general] investigation.”