Wednesday, February 27, 2008

FDA plans new post-approval drug safety effort

A step in the right direction...Hopefully the FDA will start to knock these issues off one at a time...hopefully, the follow-through doesn't bog down in bureaucracy...

WASHINGTON (Reuters) - The U.S. Food and Drug Administration is launching a new effort meant to strengthen its oversight of prescription drugs after they win approval, an agency official said on Tuesday.

The plan, called "Safety First," includes creation of a new database of possible side effects from medicines, plus clear schedules for following up on concerns about them.

The effort was first reported by the Wall Street Journal. FDA spokesman Christopher DiFrancesco confirmed the information in the Journal's story.

The action is the FDA's latest move to address charges that the agency has been slow to respond to potential side effects that emerge after a medicine reaches the market.

link to full article

1 comment:

Daniela said...

The FDA’s current system for consumers to report drug side effects, called Medwatch has been estimated to collect only 1 to 10 percent of all adverse events – because consumers don’t know about it!

Last year, Congress passed legislation requiring all printed drug ads to include Medwatch’s 1-800 number and website information, but left it to the FDA to determine if such information should also be included in TV ads. Their recommendation is due in March: it’s time to let the FDA know that we are serious about better reporting and giving consumers this potentially life-saving information. Take action at! Sign the petition and tell the FDA that TV drug ads should tell consumers where to report side effects.