While proponents of FDA reform are still working to beat the odds (and the clock) and get legislation passed this year, they have already identified the vehicle that will re-animate the issue in the next session of Congress: reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA).

There is still an outside chance that the 104th Senate will, in its last days, consider Sen. Nancy Kasssebaum's FDA reform bill, S. 1477. Kassebaum (R-Kan.) has met in the last few days with majority leader Trent Lott (R-Mo.) and Health and Human Services Secretary Donna Shalala. The former said he is inclined to provide floor time for a debate and a vote, if Kassebaum can secure sufficient Democratic support to ensure that the time won't be filled with parliamentary maneuvers meant to kill the bill.

Shalala reportedly said the administration would like to see a bill passed, if the most objectionable items are removed, including weakening FDA's ability to police dissemination of information and tighter time constraints on reviews.

In the rather unlikely event that a version of the Kassebaum bill is enacted before Congress adjourns for the fall campaigns, it will represent the beginning, not the end, of the kinds of reforms the biotech industry wants. And regardless of which candidate is in the White House and which parties control the House and Senate, there will be efforts to enact more substantial changes.

Vector for reform

Reauthorization of PDUFA, which expires next year, provides a vector for FDA reform that could be immune to some of the bugs that infected FDA reform efforts this