Friday, August 9, 2013
Should the FDA change the rules that apply to generic drug manufacturers?
The FDA recently announced its intention to adopt new regulations that would allow (and presumably encourage) generic drug manufacturers to add or update the safety warnings on their products. Currently, they are required to have exactly the same warnings as the name brand products. The new rule would allow the generics to decide what to include in their own warnings, which may result in disparities in the warning content and language among manufacturers. It will also open the door to debates arguments as to which warnings are "better". Should the FDA change the rules and allow generic drug manufacturers more freedom in deciding matters related to warnings? Some say yes (here), others say no (here).
Labels:
FDA,
Pharmaceuticals,
Preemption,
Products liability,
Warnings