To help prevent outbreaks of food-related illness and problems like the formula shortage that left many parents in the US without adequate access to food for their babies, the US Food and Drug Administration needs a clearer mission and a different kind of leadership, and it has to act with more urgency, according to a highly critical new report.
When Congress passed the the Tobacco Control Act in 2009, it amended the federal Food, Drug, and Cosmetic Act to give the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution and marketing of tobacco products for the first time.
The U.S. Food and Drug Administration has “significantly and substantially failed” to fulfill its congressional mandate to protect the public health, Americans for Tax Reform (ATR) told the Reagan-Udall Foundation in a letter.
There are no shortage of battles, or even just sharp disagreements, over how food and agriculture policy should work. At times, it can get downright ugly.
Updated guidance on expanded access program clarifies that sponsors do not risk enforcement for off-label promotion if they post investigational drug expanded access policies, although that fear already may have subsided.
The U.S. Food and Drug Administration is in disarray and influenced by outside forces rather than scientific research, according to several comments submitted to the Reagan-Udall assessment of the performance of the FDA’s Center for Tobacco Products (CTP).
As the Reagan-Udall Foundation undertakes its review of the FDA’s tobacco program, a number of legal, industry and public health experts are presenting the expert panel with written and oral comments about the major issues they see with the Center for Tobacco Products’ processes and operations.
TOBACCO PROGRAM REVIEW PANEL ENTERS DAY 3 OF LISTENING SESSIONS — The five-person expert panel tasked with evaluating the FDA’s tobacco regulatory program will embark on its final listening sessions from industry, legal and public health experts today.
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Members of the Food and Drug Administration’s food program evaluation panel have a big job as they develop recommendations for FDA guidance.
At a public meeting last month and in the hundreds of comments received through the online portal members of a Reagan-Udall Foundation panel tasked with examining the agency’s “structure/leadership, authority, resources and culture” were told that problems in the food program are deep-rooted and complex, leading to a lack of accountability and delayed decision-making.
Editor’s note: This is a letter sent by a large coalition of consumer and industry groups to Jane Henney, the chair of the Independent Expert Panel – FDA Human Foods Program of the Reagan-Udall Foundation, that is charged with investigating operations at the Food and Drug Administration.
Dear Dr. Henney:
The undersigned coalition appreciates the opportunity to submit comments to the Reagan-Udall Foundation as part of its review of the foods program at the Food and Drug Administration (FDA).
