Showdown looms in Washington over FDA reforms

The new Congress [1] is coming out of the gate bristling with proposals [2] for reforming the FDA and putting new reins on the biopharma industry. New measures would restrict drug advertising [3] 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 [4] for financing the FDA. Billy Tauzin (photo [5]) 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 [6] 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 [7]

Related Articles:
Drug makers to face many battles with Dems. Report [8]
Does the FDA do enough to regulate drug ads? Report [9]
FDA offers safety reforms to skeptical lawmakers. Report [10]