Clinton-era FDA commissioner to lead the external review of the agency’s key offices

FDA Commissioner Robert Califf said he asked the foundation to conduct an independent review of the offices in July amid protests from lawmakers and the public over the agency’s actions on infant food shortages and the delay in regulating e-cigarettes. .

Henney was the first woman to lead the FDA and served in the Clinton administration. She is a member of the Health Care Policy Foundation’s Audit and Compliance Committee at the Commonwealth Fund and sits on the board of directors of AmerisourceBergen, a wholesale pharmaceutical company. She could not be contacted for comment at the time of publication.

The former agency and regulators are skeptical that this overhaul will lead to significant changes in the agency, in part due to Reagan-Udall’s ties to the FDA and industry.

“I expect they will give some sort of low impact fruit recommendations,” said a former senior FDA official, who was granted anonymity to speak candidly on the matter. “Anytime you have someone who is connected to the FDA, including Dr. Henney, you will probably have a certain propensity for low-flying fruit.”

The recent infant formula for the infant crisis has stepped up scrutiny by the agency’s food safety division. Contaminated infant formula claimed the lives of more babies earlier this year and contributed to severe shortages for many months. Many strangers had questions about how the FDA had failed to act on formula implants in unsanitary conditions for so long, and a POLITICAL investigation found a four-month delay between initial reports of contamination and a follow-up inspection. up.

“The agency’s inspection activities related to the program also need to be evaluated, particularly in light of the stresses related to the Covid-19 pandemic,” Califf said in a statement on the review. “The agency faced a number of challenges that tested our regulatory frameworks and underlined the agency’s operations, prompting me to take a closer look at how we operate.”

The Reagan-Udall Foundation was created by Congress as part of the 2007 user fee modification package. Lawmakers hired it to further the FDA’s mission while remaining independent of the federal government. It is based on funding from the agency, the food and pharmaceutical industries, grants, contracts and private donors.

“This study is exactly what Reagan-Udall was set up to do,” said Ellen Sigal, chairman of the foundation’s board of trustees, in an e-mailed 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 it is underground.”

The foundation maintains close links with the agency and the industries it regulates. Susan Winckler, CEO 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 operating funding from the FDA. Major pharmaceutical companies, including Pfizer, AbbVie, Eli Lilly and Janssen, are listed among its project backers, 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 granted anonymity to speak candidly. “This is an attempt to give it to him [Califf] some breathing room to allow him to make some decisions on how he will organize these offices for the future. “

“We are a non-profit, non-governmental organization with one purpose: to help the FDA do more to protect and promote public health,” Reagan-Udall’s Winckler said. This requires the involvement of external stakeholders and interaction with the FDA, she added.

“We continue to structure our work independently and that is how we will deliver the work here too,” he 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 conducted by its own consultants. The foundation will also create a web portal where FDA staff can submit their concerns anonymously.

“This will not be a treaty, but it will be substantial,” Winckler said.

Regulatory experts noted that while Reagan-Udall could conduct a fair review of the agency, transparency will be key to gaining public and lawmakers’ trust. “It is absolutely essential that relationships [are] considered credible, ”said Wayne Pines, former associate commissioner for the FDA and president of health care at APCO Worldwide, a management consulting firm.

He added that although he felt the foundation would be able to conduct a solid overhaul of the agency’s offices, especially given the experiential knowledge of the foundation’s staff, he understands that its financial ties to the agency and the industries it regulates may seem like distort his assessment.

“I think there is 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 Undersecretary for food safety in the United States Department of Agriculture.

But advocacy groups say they are concerned that Reagan-Udall’s ties to industry and the agency make it impossible for the foundation to conduct an objective review.

“There is a direct and obvious contractual conflict of interest there,” said Michael Carome, director of the health research group at Public Citizen, a consumer advocacy group. “What you really need is a [Government Accountability Office] investigation that would clearly be completely independent or an [inspector general] investigation.”