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.