New Court Case Stresses the Importance of Accurate Prescription Labels
This entry was posted on August, 27 2014.
Custom Labels for Drugs Must be Updated
Medicine is an always evolving field, and if a recent court case tells drug makers anything, it is that their custom labels must also change in tandem with prescriptions. Alabama.com recently reported on the Weeks v. Wyeth case, which reaffirmed that patients are allowed to sue drug manufacturers if their medicine labels mislead doctors.
All prescriptions must have labels that list the dangers and side effects of taking certain pharmaceuticals - this is pretty straight forward. It gets more complex when researchers discover new risks associated with the drug, as the label must be continually updated.
Label requirements cause even more problems when it comes to generic drug makers, who must convince the Food and Drug Administration that their versions of medicine are the bio-equivalent of the brand drug. If it is not, the FDA will not approve it. At the same time, generic drug manufacturers are not permitted to alter the label by law, which can lead to problems when the brand maker updates the labels but the generic lags behind.
Keep Compliance in Mind
Certain types of custom labels for specific products must contain key points to remain compliant with laws and regulations, it is crucial product manufacturers keep that in mind.