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The Public Citizen Pleas with FDA to Allow Generic Label Updates

By September 12, 2011July 10th, 2019Uncategorized

The Public Citizen has issued a plea to the Food and Drug Administration that asks the agency to let generic drug makers make changes to their drug labels to include warnings and risks for patients whenever they learn of new risks the drugs pose.

Public Citizen did this by filing a petition with FDA on August 26 that said the regulators should change the current rules that bar generic drug companies from being able to alter their labels in accordance with new risk information. The group has said that the makers of generic drugs should be forced to update health information on drugs. This is a wonderful idea, and one that generic drug companies likely don’t want any part of because that would allow patients to see just what could happen to them if they take the drugs, and that would interfere with the drug makers’ revenue stream.

There is little doubt that The Public Citizen petition was created as a response to a recent decision handed down by the Supreme Court in a generic Reglan case. The case, PLIVA v. Mensing, was a landmark case that left the plaintiff, Gladys Mensing, unable to file a lawsuit against the generic drug makers after she suffered from tardive dyskinesia as a result of taking the generic Reglan (metoclopramide).

The court made its decision after considering that current FDA regulations state that patients who suffer drug injuries after taking generic medications can’t sue on the basis of a lack of warning as long as the labels are the same as on the brand name equivalent. The reason for this is because state laws and federal laws regarding labels differ. That simply doesn’t make sense to many people, including some of the justices who ruled on the case.

The ruling has also left many people wondering what will happen to the generic cases that have already been filed. It turns out they needn’t worry, as most will likely just have to move their cases to state courts so that they can file their lawsuits against Wyeth, the makers of brand name Reglan, instead. It will take longer to get the trials underway, but it’s better than nothing.