Terrell · Hogan

Quick Navigation
Leaders Forum 2016
Search Site

By Wayne Hogan and Christopher Shakib

Today, when generic drugs turn out to be dangerous, injustice governs the legal rights of patients when personal injury or wrongful death occur whether that is in Jacksonville or anywhere else in the United States. The Food and Drug Admin­is­tration (FDA) has announced its intent to restore the legal rights of patients by making generic drug manufac­turers accountable to properly update generic drug labeling when dangers are identified. However, the FDA’s sensible announcement is expected to be met with opposition, so it is important for the FDA to know that the people support its effort to protect their rights.

To help support the FDA’s common­sense decision the American Associ­ation for Justice’s grass­roots and public education campaign, Take Justice Back, has provided an online petition applauding the FDA for taking action to revise regula­tions so generic drug manufac­tures update their warning labels. You can sign the petition online by clicking here and send the link to your family and friends and share it online at post it on social media using the hashtag #RxJustice.  (The Terrell Hogan personal injury and wrongful death law firm is a Leaders Forum supporter of the work of the Associ­ation for Justice and Take Justice Back.)

Also, fifteen patient and consumer advocate organi­za­tions including AARP have sent a letter to Margaret Hamburg, M.D., Commis­sioner of the FDA, applauding the FDA’s announcement to revise its regula­tions so generic drug manufac­turers update their drug safety labels and to restore Americans’ right to quality drug safety infor­mation.  Click here for the letter.

Here are the highlights of the FDA’s proposed rule on generic drug labeling:

-The proposed regula­tions permit generic drug companies to initiate warning changes (overturning the Mensing decision that damaged patients’ rights).
-The proposed regula­tions also require all generics to conform their labeling to an approved change within 30 days. Previ­ously, the regula­tions only required them to do this as soon as possible.
-Lastly, both brand name drugs makers and generics drug makers now may use the change process to add new warnings to the “Highlights” section of a new drug labels. This was previ­ously restricted.

Click here for a link to the proposed rule.