Monday, October 13, 1997
The apparent ease with which FDA reform legislation finally
sailed through Congress - a 98-2 Senate vote and passage by acclamation in the
House - reflects lawmakers' eagerness to get the issue behind them as much as
their enthusiasm for the bills. But as anyone who has followed the saga of FDA
reform knows, getting any changes at the agency was hardly a sure bet until
the bitter end. In fact, tying changes at the FDA to reauthorization of the
Prescription Drug User Fee Act (PDUFA) was the engine that propelled reforms
through the political process.
Although a few more details must be attended to, including
reconciling the House and Senate versions of FDA reform legislation, President
Clinton is expected to sign a bill by Halloween.