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.
