James M. Jeffords: “I salute the majority leader for moving the debate on the FDA modernization forward. We should no longer needlessly…”

“I salute the majority leader for moving the debate on the FDA modernization forward. We should no longer needlessly delay consideration of S. 830, the Food and Drug Administration Modernization and Accountability Act of 1997. S. 830 represents months of bipartisan effort to address serious shortcomings in the FDA's regulatory procedures. Two hearings were held. The measure passed the committee with a strong bipartisan 14-to-4 vote, and months of negotiations have ensued with dozens of accommodations made for Senator Kennedy and the administration. For almost 20 years, Congress, the General Accounting Office, and numerous advisory commissions have examined, reviewed, and made recommendations to modernize the FDA. During 1978 and 1979, Senator Kennedy championed legislation that would have required FDA to do some of the very same things we are requiring of it in S. 830. In 1982, the Commission on the Federal Drug Approval Process, convened at the request of Representatives Albert Gore and James Scheuer, recommended simpler investigational new drug requirements.”