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Closing the Loop-Holes in Generic Drug Warnings


The Food and Drug Administration is considering some very important changes to its internal rules that would help to eliminate a loophole in accountability for defective drugs.   Under current law, only the brand name manufacturer is permitted to change the warning label for a particular drug.   After a drug is approved for sale and is ingested by large number of patients, it is not uncommon for additional safety issues to emerge or for better information to become available regarding potential adverse events.  Currently, if the brand name manufacturer fails to put this vital safety information into the drug’s warning label, the generic manufacturer is forbidden from changing the labeling; even to provide better safety information in the warning label for the generic version of the same drug.  The problem is that brand name manufacturers often stop actively marketing their drugs after generic versions become available. Also, generic drug manufacturers are far more likely to be aware of potential safety issues with a particular drug since the majority of prescriptions (some studies indicate nearly 80%) are filled with generic rather than brand name drug formulations.

The new proposed FDA rule changes will permit generic drug manufacturers to update the warning labels for their drugs rather than being required to merely mimic the language from the brand name warning label.  This common sense change in the rule will help to restore accountability for generic drug manufacturers. Under current law, as confirmed by the United States Supreme Court in the Pliva v. Mensing case, generic drug manufacturers are not being held legally accountable for the harm caused by the drugs that they sell.  Further, many courts have refused to hold brand name manufacturers, who do have control over the content of the drug’s warning label, responsible for harm caused by a generic version of the brand name drug which was sold by a different manufacturer. 

The tragic result of generic preemption is that no drug company is responsible when patients are harmed by a generic drug.  Patients who have suffered significant injuries are left without any legal recourse, and the drug companies who have made millions (if not billions) in profits are not required to compensate the plaintiffs who they have harmed.  This granting of immunity to Big Pharma is egregious and runs completely counter to any definition of justice. 

One can only hope that the FDA’s proposed rules are quickly adopted so as to prevent further harm to patients injured by defective drugs.  Many thanks to the following members of Congress who wrote to the FDA urging adoption of the proposed rules:

Gwen Moore, Bruce Braley, Louise McIntosh Slaughter, Matt Cartwright, Marcy Kaptur, William Keating, Joseph P. Kennedy III, Barbara Lee, Zoe Lofgren, Betty McCollum, Ed Perlmutter, Mark Pocan, Lucille Roybal-Allard, Janice Shakowsky, Terri Sewell, Carol Shea-Porter, and Chris Van Hollen

A group of State Attorneys General from Arizona, Arkansas, Colorado, Connecticut, Delaware, Hawaii, Idaho, Illinois, Iowa, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New Hampshire, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Vermont, Virginia, and Washington also submitted comments to the FDA in support of the proposed changes. 

I am disappointed that the signature page for the letter from Congress does not include hundreds of additional Senators and Representatives.  Sadly, but not surprisingly, the leaders in my home state of Florida did not feel the need to join in support of this effort which would provide greater patient safety to Florida’s residents, who, due to their age and complex medical issues, are some of the most vulnerable patients in the country.

We can only hope that voters will remember those who stood up for justice and for innocent victims and those who did not.  

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Posted By: Samantha Saundry