FDA seeks faster warning updates for generic drugs

November 8, 2013

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.

Explore further: Court: Can generic makers be sued for drug flaws?

Related Stories

Court: Can generic makers be sued for drug flaws?

November 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)

June 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 ...

Regenstrief study finds that generic drugs often have incorrect safety labeling

December 13, 2012
Despite U.S. Food and Drug Administration regulations requiring generic medications to carry identical warnings to those on corresponding brand-name products, a study by Regenstrief Institute researchers has found that more ...

Court: Can generic drug maker be sued over design?

March 19, 2013
The Supreme Court will soon decide whether generic drug manufacturers can be sued in state court for a drug's design defects after federal officials approved the brand-name version.

US court rules to protect generic drug makers

June 24, 2013
Manufacturers of generic drugs cannot be sued for adverse side effects caused by products that they did not themselves design, the US Supreme Court ruled on Monday.

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.