FDA seeks faster warning updates for generic drugs

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 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, 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.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Court: Can generic makers be sued for drug flaws?

Nov 30, 2012

(AP)—The Supreme Court will decide whether generic drug manufacturers can be held responsible in state courts for possible design defects that are in the brand-name medicine they are copying.

US: 'Pay to delay' generic drugs can be illegal (Update)

Jun 17, 2013

The Supreme Court ruled Monday that deals between pharmaceutical corporations and their generic drug competitors, which government officials say keep cheaper forms of medicine off the market, can be sometimes be illegal and ...

Recommended for you

Added benefit of vedolizumab is not proven

15 minutes ago

Vedolizumab (trade name Entyvio) has been approved since May 2014 for patients with moderately to severely active Crohn disease or ulcerative colitis. In an early benefit assessment pursuant to the Act on the Reform of the ...

Seaweed menace may yield new medicines

23 hours ago

An invasive seaweed clogging up British coasts could be a blessing in disguise. University of Greenwich scientists have won a cash award to turn it into valuable compounds which can lead to new, life-saving drugs.

User comments