Showdown looms in Washington over FDA reforms

The new Congress is coming out of the gate bristling with proposals for reforming the FDA and putting new reins on the biopharma industry. New measures would restrict drug advertising as well as create a new office of drug safety to oversee medications after they're approved. Similar measures have been floated before and never had a chance. But the new Democratic majority--allied with several senior Republicans angered by the agency's safety record--appear emboldened to act fast, which has industry officials somewhat alarmed.

The key concern among the trade groups is that the reformers are likely to piggy-back on the reauthorization of the user-fee bill, an essential piece of legislation for financing the FDA. Billy Tauzin (photo) at PhRMA says the bill could become a "Christmas tree" loaded with new measures. The drug industry is banking on a compromise pact with the FDA that increases user fees by about a third, up to $393 million next year. And they're hoping the extra money will help grease the tracks to get the bill through without reformers tacking on any new safety measures. Without a new user fee authorization the agency's drug regulation work will essentially be frozen by late summer, setting the stage for a major showdown in Washington.

- read the report on the Washington scene from The Wall Street Journal (sub. req.)

ALSO: HHS has also updated clinical trial regs, saying that all unanticipated problems in a trial have to be reported. An unanticipated event is not an adverse event, which are frequently anticipated. Report