According to the US newspaper, the report released by the Breckenridge Institute, a Colorado-based consulting firm, found that the FDA is currently relying on a "dysfunctional" computer system and will have to continue doing so as the upgraded system it was planning to build will not be in place for at least another two years.

Instead, the report said, the FDA could have saved an estimated $25m (€19m) - the amount it has wasted so far - if it had chosen to use off-the-shelf software which could have been up and running in 2005, according to the WSJ.

The study also said that FDA safety experts waste an average of 45 minutes every day because of the current software's inefficiencies and hurdles.

The FDA has been planning for years to upgrade the technology called Adverse Events Reporting System (AERS II) it uses to monitor the safety of drugs once they have reached the market.

Shortly after the Vioxx episode in 2004, when the importance of monitoring drugs after their launch was highlighted, the US regulator came up with a series of improvements of its drug safety system, including the implementation of a Center-wide electronic safety tracking system system to ensure a consistent approach across the Center for Drug Evaluation and Research (CDER).

It is at that time as well that the agency first announced the upgrade of AERS II to add signal detection and tracking tools.

But according to the report, this overhaul of the system will be delayed until 2009 at the earliest.

FDA officials have prepared a draft document in response to the report, said the WSJ, which said the study is "riddled with editorial conclusions based on misleading and incorrect facts."

Spokespeople for the agency could not be reached for comment.