As a result of the Mensing case the legal rights of more than 80 % of America’s population was placed at risk. If you are injured as a result of taking a generic drug, you have no legal rights for the failure to warn of the dangers known to be associated with that drug . See http://www.
chrisplacitella.com/2013/01/ 17/alabama-supreme-court- brand-drugmakers-can-be-held- liable-for-generic-drug- labeling/
The FDA is seeking to change that ruling and restore to people their legal rights and to protect the public health .
Last week the FDA made public their proposed rule on generic drug labeling. Here are the highlights:
-The proposed regulations permit generic drug companies to initiate CBE changes (overturning the Mensing decision).
-The proposed regulations also require all generics to conform their labeling to an approved CBE change within 30 days. Previously, the regulations only required them to do this as soon as possible.
-Lastly, both brands and generics now may use the CBE process to add new warnings to the “Highlights” section of a new drug labels. This was previously restricted.
Please sign the online petition and share it with your family and friends. This remains extremely important as the rule is still in the proposed phase: https://www.change.org/