FDA Commissioner Robert Kaliff said he asked for the fund conduct an independent audit of offices in July, against the backdrop of protests by the legislator and the public over the actions of the agency to lack of baby food as well as delayed regulation of e-cigarettes.
Henny was the first woman to head the FDA and served in the Clinton administration. She is a member of the Health Policy Fund Audit and Compliance Committee at the Commonwealth Foundation and serves on the Board of Directors of AmerisourceBergen, a wholesale pharmaceutical company. She could not be contacted for comment at the time of publication.
Former agency experts and regulators are skeptical whether the review will result in meaningful change at the agency, due in part to Reagan-Udall’s ties to the FDA and industry.
“I expect them to make some light recommendations,” said one former senior FDA official, who was granted anonymity to speak candidly on the matter. “Every time you have someone who is associated with the FDA, even including a doctor. Henny, you’ll probably have some bias in favor of low-hanging fruit.”
The recent infant formula crisis has heightened the focus on the agency’s food safety department. The contaminated formula led to numerous infant deaths earlier this year and contributed to severe shortages for many months. Many outsiders had questions about how the FDA took so long to take action on unsanitary infant formula factories, and the POLITICO investigation revealed four month delay between initial reports of contamination and subsequent inspection.
“The agency’s inspection activities related to the program also need to be evaluated, especially in light of the stress associated with the Covid-19 pandemic,” Kaliff said in a statement regarding the inspection. “The agency has faced a number of issues that have put our regulatory framework to the test and put the agency’s operations at risk, prompting me to take a closer look at how we do business.”
The Reagan-Udall Foundation was created by Congress in accordance with the 2007 user fee amendment 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 industry, grants, contracts, and private donors.
“This study is exactly what Reagan-Udall was created to do,” said Ellen Segal, chairman of the foundation’s board of directors, in a statement emailed to POLITICO. “I am confident that we will provide the FDA with a useful report and that the process will be robust, independent and transparent once it is in place.”
The Fund maintains close ties with the agency and the industries it regulates. Susan Winkler, chief executive of Reagan-Udall, was formerly FDA chief of staff. Mark McClellan and Andrew von Eschenbach, 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 listed as sponsors of the project, as are food industry giants Kellogg and Nestlé USA.
“Reagan-Udall will work with Kaliff,” said another former senior FDA official familiar with the matter. He was also granted anonymity in order to speak frankly. “This is an attempt to give him [Califf] a bit of breathing room to let him make some decisions about how he’s going to organize those offices in the future.”
“We are a non-profit, non-governmental organization with one goal – to help the FDA do more to protect and promote public health,” said Reagan-Udall’s Winkler. She added that this requires some input from external stakeholders and interaction with the FDA.
“We continue to structure our work in an independent way, and that is how we will do the work here as well,” she said.
Winkler said the foundation’s investigation would produce two baseline reports on the activities of each of the criticized divisions. Each report will be led by its advisor. The Foundation will also create a web portal where FDA staff can anonymously report their concerns.
“It won’t be a treatise, but it will be meaningful,” Winkler said.
Regulatory experts have noted that while Reagan-Udall may conduct an objective review of the agency, transparency will be key to gaining the trust of the public and lawmakers. “It is absolutely essential that the reports [are] considered credible,” said Wayne Pines, former FDA assistant commissioner and president of public health at APCO Worldwide, a management consulting firm.
He added that while he believed the fund would be able to conduct a thorough due diligence of the agency’s offices – especially given the experience of the fund’s staff – he understands that his financial ties to the agency and the industries it regulates may seem biased in his 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 stakeholder perspective,” said Brian Ronholm, director of food policy at Consumer Reports and former Deputy Undersecretary for Food Safety at the USDA.
But advocacy groups say they are concerned that 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 Carom, director of the health research group at Public Citizen, a consumer advocacy group. “What is really needed is [Government Accountability Office] an investigation that would clearly be wholly independent or [inspector general] the study.”