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

Using computers to design drugs

20 hours ago

Designing a new medicine is an expensive and time consuming business. Typically it takes around $2 billion and ten years for a new drug to move from its initial design in the lab, to the clinic. All the ...

Lilly psoriasis drug fares well in late-stage test

Aug 22, 2014

Drugmaker Eli Lilly and Co. said its potential psoriasis treatment fared better than both a fake drug and a competitor's product during late-stage testing on patients with the most common form of the skin disease.

New US restrictions on painkiller to take effect

Aug 21, 2014

The federal government is finalizing new restrictions on hundreds of medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

User comments