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Dangerous Generic Drugs: Important Update on Your Rights

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.


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About The Author

Picture of Laura Hack

Laura Hack

Laura Hack is a paralegal with Terrell • Hogan. She has been with the firm since 1996 and has worked primarily for Wayne Hogan. She is an experienced Paralegal with 30+ years of working in the law practice industry. Skilled in Appeals, Civil Trial Litigation Support, Torts, Trial Practice, and Pleadings.