The FDA is putting researchers on notice: If you manipulate data or put study participants at unnecessary risk, you'll face debarment and disqualification as an investigator of new drugs and devices. And trial sponsors will find it easier to identify researchers who are prohibited from participating in new work.

"The FDA views any deviation from its high standards for developing or marketing drugs and devices as a potential threat to patient safety and public health," said Norris Alderson, the FDA's associate commissioner for science. "We will take strong action against anyone who chooses to ignore or flout the legal requirements for the products we regulate."

The FDA is moving to address critics who have maintained that the agency hasn't done enough to guard the public from unnecessary risks. And it fits in neatly with the agency's new mandate to make public safety a top priority of the new Obama administration.

Just days ago the new FDA Commissioner Peggy Hamburg excoriated the FDA's reputation for slow-motion enforcement procedures. There has been way too much "back and forth, stall and delay, let's see what the company does," Hamburg said in a speech.

- read the FDA release
- check out the report from the Wall Street Journal

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