The FDA hired the Reagan-Udall Foundation, along with unnamed experts, to review the Food and Tobacco major offices. The foundation, an independent group mandated by Congress to advise the FDA and help improve the agency’s regulatory and oversight processes, will assess the resources, procedures and organization of both the office and the Office of Regulatory Affairs. which conducts the inspection.
Although the foundation has no legal authority over the FDA, it has enjoyed a close relationship with the agency’s top officials and helped shape the commissioners’ priorities.
“I would like to hear more details about how the foundation ensures the independence of their process, especially given that the foundation’s purpose is to support the FDA’s mission,” said Brian Ronholm, former assistant secretary of agriculture for food safety. department.
Part of the review will be the agency’s Human Foods Program, focusing on the Office of Food Policy and Response, the Center for Food Safety and Applied Nutrition. “Fundamental questions about structure, function, funding and leadership need to be addressed,” Califf said, noting that offices have been particularly stressed by the pandemic.
In addition, the review will affect the Center for Tobacco Products, which has been responsible for the regulation of tobacco products for the past 13 years. “Challenges lie ahead as we determine how the agency will address complex policy issues and determine enforcement activities for a growing number of new products with potentially significant public health implications,” said Califf.
Lawmakers from both parties have been increasingly critical of the agency’s response to the infant formula shortage and Caliph’s response. In May, Califf pointed to “systemic issues at the FDA” contributing to the baby formula backlash, prompting Senate HELP chairman Patty Murray (D-Wash.) to request a plan to address these concerns.
“I’m going to continue to push to see this plan,” he said during a hearing in May. “I requested this plan weeks ago and I will not stop until I see it. It’s life or death, and Dr. Califf, it just shouldn’t take this long.
Top California and FDA officials have also been under pressure from outside groups in private meetings in recent months, particularly in the past few weeks, urging them to appoint a deputy food commissioner and push for greater reforms to the food program.
In addition, members of Congress have expressed displeasure with the agency’s regulation of e-cigarettes. Senate Majority Whip Dick Durbin (D-Ill.) went so far as to call for Califf’s resignation because certain e-cigarette products remain on the market while the agency reviews their marketing applications. The FDA court-ordered deadline for e-cigarette marketing applications was September 9, 2021.
Last week, House Appropriations Chairman Rosa DeLauro (D-Conn.) and Durbin reintroduced legislation that would have created a new food safety agency to be housed under HHS — breaking up the Food and Drug Regulatory Agencies.
The announcement of the external review came as a surprise to former FDA officials. “This is news to me,” said Mitch Zeller, former head of the Center for Tobacco Products. “I have no intelligence and no idea what caused this.”
“It probably precedes supervision and [the Office of the Inspector General]and give him cover to make organizational changes,” a former senior FDA official told POLITICO, speaking on condition of anonymity and speaking candidly about the review.
Another person with direct knowledge of the matter said the Office of Regulatory Affairs is also experiencing turmoil. The person said that the person had left the office recently. Some retired and others chose to leave the agency due to dissatisfaction with inspection work, including organizational issues and inadequate pay.
“In light of certain developments in recent months, the commissioner has determined that these areas merit a closer evaluation of certain processes, procedures and resources, as well as a review of the current leadership structure,” an FDA spokeswoman said in an email. politics.
“This has been a very difficult time for the agency,” said Ellen Segal, chair of the Reagan-Udall Foundation’s board of directors, citing Covid-19 and the FDA’s efforts to quickly review new vaccines and treatments. Siegal said Califf approached the foundation for a review.
“When Rob [Califf] came in, there were things happening that he wasn’t really a part of, but he obviously inherited,” he said.
What is the following: In addition to this review, the Inspector General of the Department of Health and Human Services is conducting an investigation About how the agency grants accelerated approvals to certain drugs, prompted in part by the agency’s decision last year to approve a controversial Alzheimer’s drug from Biogen.
The Reagan-Udall Foundation will complete the initial evaluation within 60 days. “It may take some time to implement any recommended changes, but I am committed to addressing them and bringing them to the public in a timely manner,” Califf said.
Erin Banko, Meredith Lee, David Lim and Sarah Overmohle contributed to this report.
FDA Announces External Review of Food Safety and Tobacco Regulatory Offices
Source link FDA Announces External Review of Food Safety and Tobacco Regulatory Offices