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FDA Moves to Close Loophole

Back in 2011, the Pliva v. Mensing ruling from the Supreme Court of the United States revealed a loophole in federal regulation of generic drugs.  Generic drug manufacturers were not responsible for the updating of labels; it was left to brand name companies. In the past two years, the Food and Drug Administration (FDA) has moved towards closing this regulation loophole.  After a public comment period, requirements are expected to change and these generic drug companies may bear new responsibility and liability in the maintenance of proper labeling. After this period, proponents of the move assure that patient safety will be enhanced.

 

 

For a more in-depth look at the issue, read the Today show report here:

http://www.today.com/news/safety-advocates-loophole-puts-users-generic-drugs-risk-8C11545187#safety-advocates-loophole-puts-users-generic-drugs-risk-8C11545187