FDA Seeks Faster Warning Updates for Generic Drugs

By: Associated Press Email
By: Associated Press Email

WASHINGTON (AP) -- The Food and Drug Administration is seeking a rule change to allow generic drugmakers to quickly update their warning labels with new safety information for doctors and patients.

Current regulations require generic drugs to bear the same labels as their branded counterparts. That policy has left generic companies with little control over their drug labels, and also shielded them from legal liability in court.

In 2011, the Supreme Court ruled that generic drugmakers cannot be sued for failing to warn consumers about possible side effects of their products if they use the exact same warnings as the original medicines.

Under today's proposal, generic drugmakers would have the same power as brand-name drug makers to update their drugs with new information.

Regulators will take comments on the proposal for 60 days.


Join the Conversation!

To comment, the following rules must be followed:

  • No Obscenity, Profanity, Vulgarity, Racism or Violent Descriptions
  • No Negative Community Comparisons
  • No Fighting, Name-calling, or Personal Attacks
  • Multiple Accounts are Not Allowed
  • Stay on Story Topic

Comments may be monitored for inappropriate content, but the station is under no legal obligation to do so.
If you believe a comment violates the above rules, please use the Flagging Tool to alert a Moderator.
Flagging does not guarantee removal.

Multiple violations may result in account suspension.
Decisions to suspend or unsuspend accounts are made by Station Moderators.
Questions may be sent to comments@wsaw.com.
Please provide detailed information.
All comments must adhere to the WSAW.com discussion rules.

powered by Disqus
WSAW-TV 1114 Grand Ave. Wausau, WI 54403
Gray Television, Inc. - Copyright © 2002-2014 - Designed by Gray Digital Media - Powered by Clickability 231210351 - wsaw.com/a?a=231210351