Drug Side Effects Report Cards - FDA

U.S. proposes 'report cards' for drugs

Last Updated: Tuesday, January 30, 2007 | 7:03 PM ET

Drug "report cards" may list any unexpected side-effects that become known within 18 months of a drug's approval, the U.S. Food and Drug Administration said Tuesday in response to criticism of the agency's drug safety oversight.

In September 2006, a panel of experts at the U.S. Institute of Medicine said the FDA needed to boost its staff, funding and power to track the safety of not only new medications, but also drugs already on the market.

The panel met after Merck & Co. pulled its anti-inflammatory drug Vioxx from the market in 2004, five years after it was approved. Long-term use of the drug was linked to an increased risk of heart attack and stroke.

The institute's report concluded that FDA officials downplayed concerns raised by safety reviewers after drugs were approved. The report also suggested the FDA did a poor job of managing scientific disagreements among staff.

In its response on Tuesday, the FDA said it was "making specific organizational and management changes to increase communications among FDA review staff and safety staff."

The response is not the final word, FDA Commissioner Dr. Andrew von Eschenbach said.

"It will be a continuous process of improvement. The initiatives we are announcing today are not the full story, nor are they the final chapter in that story," von Eschenbach told reporters in Washington.

The FDA's response includes plans to:

• Upgrade its electronic database for tracking potential side-effects.
• Create a new advisory panel on risk communication.
• Publish regular newsletters summarizing safety reviews of older drugs, including any emerging issues that do not include information the agency considers confidential.

The response came days before U.S. senators are to introduce legislation for drug safety changes.

Source: CBC.ca