FDA Commissioner Robert Califf said he asked the foundation Conduct independent review of offices In July, in the background of the protests of the deputies and the public, regarding the actions of the agency Infant formula deficiency and Delayed e-cigarette regulation.
Haney was the first woman to head the FDA and served in the Clinton administration. He is a member of the Audit and Compliance Committee of the Commonwealth Fund’s Health Policy Fund and sits on the board of directors of AmerisourceBergen, a wholesale drug company. He could not be reached for comment at the time of publication.
Former agency and regulatory experts are skeptical that the review will lead to significant changes at the agency, in part because of Reagan-Udall’s ties to the FDA and industry.
“I would expect them to make some recommendations on the low-hanging fruit,” said one former senior FDA official who spoke on condition of anonymity and spoke candidly about the matter. “Anytime you have somebody involved with the FDA, including Dr. Haney, you’re probably going to get a bias against the low-hanging fruit.”
The recent infant formula crisis has heightened scrutiny of the agency’s food safety division. Contaminated formula caused the deaths of several infants earlier this year and contributed to months of severe shortages. Many outsiders have questioned how the FDA has been unable to enforce unsanitary formula on plants for so long, a POLITICO investigation found. Four months late between initial reports of contamination and subsequent inspections.
“The agency’s inspection activities related to the program must also be evaluated, especially given the stresses associated with the Covid-19 pandemic,” Califf said in a statement about the review. “The agency has faced a number of challenges that have tested our regulatory framework and stressed the agency’s operations, prompting me to take a closer look at how we do business.”
It was the Reagan-Udall Foundation Created by Congress As per the 2007 User Fee Amendment Package. Lawmakers established it to advance the FDA’s mission while remaining independent from the federal government. It relies on agency, food and pharmaceutical industry funding, grants, contracts and private donors.
“This study is exactly what Reagan-Udall was created to do,” Ellen Segal, chair of the foundation’s board of directors, said in a 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 implemented.”
The Foundation maintains close ties with the agency and the industries it regulates. Susan Winkler, executive director of Reagan-Udall, was formerly 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 drug 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 tied to Calif,” 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 about how he’s going to organize those offices moving forward.
“We are a non-profit, non-governmental organization with one goal, and that is to help the FDA do more to protect and promote public health,” said Winkler of Reagan-Udall. This will require some external stakeholders to engage and interact with the FDA, he added.
“We continue to structure our work independently, and that’s how we’ll do it here,” he said.
Winkler said the foundation’s investigation will create two baseline reports focused on each department’s operations that are critical. Each account will be managed by its own advisors. The foundation will also create a web portal where FDA employees can submit their concerns anonymously.
“It won’t be a treatise, but it will be substantial,” Winkler said.
Regulatory experts noted that while Reagan-Udall could provide a fair review of the agency, transparency will be key to winning the trust of the public and lawmakers. “It is absolutely essential that the reports [are] It’s seen as credible,” said Wayne Pines, a former associate commissioner of the FDA and president of APCO Healthcare Worldwide, a management consulting company.
He added that while he believed the fund would be able to conduct a robust review of the agency’s offices — especially given the experience of the fund’s staff — he understood that his financial ties to the agency and the industries it regulates could appear to bias his assessment.
“I think there’s reason to be cautiously optimistic about the process they’re going to use to conduct this review, both from a transparency and stakeholder standpoint,” said Brian Ronholm, director of food policy at Consumer Reports and director of the U.S. Department of Agriculture. Former Deputy Secretary for Food Safety.
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 conflict of interest in the contract,” 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] An investigation which will obviously be completely independent or [inspector general] investigation.”
Clinton-era FDA commissioner to lead external review of key agency offices
Source link Clinton-era FDA commissioner to lead external review of key agency offices