Optimism For Senate FDA Reform Bill Advances

Last week, aides to US Senate Labor and Human Resources Committeechairman Jim Jeffords were forecasting the imminent arrival onto the Senate floor of the Food and Drug Administration modernization bill, if a few remaining issues, including national uniformity and off-label uses of approved drugs, could be resolved. A spokesman for Sen Jeffords told the Marketletter that the off-label issue is being advanced by Senators Mack and Frist and others, who were talking to Senator Kennedy's staff to see if they could resolve their differences.

Not that much has changed in the bill's drug section since the talks a while ago, a Pharmaceutical Research and Manufacturers of America spokesman told the Marketletter. When the bill comes to the floor, the PhRMA will watch closely an attempt to attach an amendment sponsored by Sens Mack and Frist to allow dissemination of information about off-label uses, with certain safeguards to make sure there is no conflict of interests; this has already been negotiated and dealt with.

Kennedy Filibuster? There are signs that Sen Kennedy will try to filibuster this, he told the Marketletter, but the bipartisan legislators believe they have the 60 votes needed to beat this. However, if a filibuster does bog the bill down, Majority Leader Senator Trent Lott could yank it from the schedule. The PhRMA spokesman agreed that the marketing of two prescription drugs as a combination when each has been approved separately is a Senate concern, pushed to the fore by reports of side effects of the phen-fen combination (Marketletter July 21), but he knew of no legislation designed to deal with this issue.