Allowing Supplemental Applications For Proposed Labeling Changes Might End Federal Preemption Shield From Legal Liability That Came With Mensing Ruling
UPDATE: The FDA’s long-awaited proposed rule on generic drug labeling is now public. You can access it using this link.
From a November 7, 2013 FDA email "announcement":
A proposed U.S. Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.
Under the proposal, generic drug manufacturers would be able to independently update product labeling (also called prescribing information or package inserts) with newly-acquired safety information before the FDA’s review of the change, in the same way brand drug manufacturers do today. Generic manufacturers would also be required to inform the brand name manufacturer about the change.
The FDA would then evaluate whether the proposed change is justified and make an approval decision on the generic drug labeling change and the corresponding brand drug labeling change at the same time, so that brand and generic drug products would ultimately have the same FDA-approved prescribing information.
This July 3, 2013 headline from a New York Times (NYT) article by Katie Thomas, "F.D.A. Rule Could Open Generic Drug Makers to Suits", was much welcomed news to many patients who have been harmed by serious side effects from generic drugs yet prevented from filing any drug injury products liability lawsuit for legal compensation.
Here is just one example. At the present time Bayer is settling YAZ, Yasmin, and Ocella lawsuits, as well as certain Gianvi cases. YAZ and Yasmin are brand-name drugs made and sold by Bayer. Ocella and Gianvi are generic drugs but were made by Bayer -- which is why Bayer is paying settlements on those cases -- and sold by Teva / Barr.
As background, like all of the drospirenone (DRSP) containing birth control pills, the YAZ, Yasmin, Ocella, and Gianvi types have been associated with an increased risk of blood clots that can cause serious side effects such as a deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
If at the time of her DVT and/or PE event a woman was taking one of the "true" generic DRSP birth control pills like Zarah, Loryna, Syeda, or Vestura, i.e., made by a generic (not brand-name) manufacturer, however, there is a completely different legal outcome for her. This is because no such drug injury cases are being filed for those women, much less settled, because at the present time one cannot successfully sue a generic drug manufacturer due the Pliva, Inc., et al. v. Mensing case decided by the Supreme Court of the United States in 2011 (the so-called "Mensing ruling"), which is explained in these earlier posts:
Returning to that July 3 New York Times article mentioned at the outset:
The Food and Drug Administration on Wednesday signaled its intention to permit generic drug makers to make changes to their safety labels, a move that could open the door to lawsuits against generic drug companies for the first time since a Supreme Court decision barred such suits two years ago.
Consumer advocates applauded the development, calling it a necessary fix for a system that they say is unfair to patients who take generic medicines.
“It’s common sense,” said Dr. Sidney M. Wolfe, a senior adviser to the Health Research Group at Public Citizen, which in 2011 petitioned the F.D.A. to pass just such a rule. “It will obviously end this situation where people are being harmed physically and yet, although they are harmed, they have no right to go into court and get redress for serious damages.”...
The F.D.A.’s intentions came in the form of a bureaucratic step in which the agency must notify the Office of Management and Budget [(OMB)] of its plans to publish a proposed new rule. In a summary posted Wednesday on the budget office’s Web site, the F.D.A. said the proposed rule would “create parity” between generic and brand-name drug makers with respect to how they update their labels — the lengthy list of a drug’s uses, dosages and risks.
Under the current system, brand-name manufacturers can change the label if they receive important new information about their drug. If the F.D.A. agrees that the label change is necessary, the generic manufacturers of the drug must also change their labels. The rule change could also allow generic manufacturers to change their labels if they became aware of safety concerns, which could make them liable if a court were to find they failed to warn patients about potential harms.
The required notice which was posted by FDA July 3 on the OMB website -- "Title: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products" -- indicates the FDA’s intent to publish such a proposed rule by September 2013, when the public would be asked to comment.
We certainly look forward to learning more about what these changes in the FDA regulations might be as regards prescription drug label revisions by generic manufacturers.
We know already that these changes are long overdue and, unfortunately, most likely too late for many patients whose statute of limitations for filing their respective drug injury lawsuit expired during the time when the Mensing ruling was the law of the land -- with its federal preemption shield from legal liability that it afforded generic drug companies and, in turn, prevented those patients from receiving any legal compensation for their serious side effects.