Disappointingly, some amendments that would have strengthened the bill were voted down, by very narrow margins. Two, offered up by Senator Grassley, would have strengthened the clinical trials disclosure piece of the bill and the other would have given the head of the Office of Drug Safety more authority. Hopefully, the House will pass a stronger bill, and really get the industry running scared. HR 1561 by Reps. Waxman and Markey would make more clinical trial results available more quickly (than what’s in the Senate bill) and would allow for a three-year advertising moratorium on new drugs with safety issues.
In this Senate bill, the industry has more of an opportunity to skate around making many of their trial results public. This is a loophole that will hopefully get fixed in the House.