Dale Bumpers: “on September 23 of this year, my colleague, Senator Cochran, chairman of the Appropriations Subcommittee on Agriculture…”

“on September 23 of this year, my colleague, Senator Cochran, chairman of the Appropriations Subcommittee on Agriculture, Rural Development, and Related Agencies, rose on the floor of the Senate to express objection to a provision of the FDA reform bill that would direct the appropriations subcommittee to provide established levels for salaries and expenses of the Food and Drug Administration through fiscal year 2002. If the appropriations bills did not meet those levels, referred to as trigger, the FDA would not be able to collect or use receipts authorized by the Prescription Drug User Fee Act [PDUFA]. The effect of the provision Senator Cochran found so troublesome would have been to place a budgetary gun to the head of the appropriations subcommittee under threat of PDUFA fees not being collected and the Nation's drug approval process placed at risk. As ranking member of the appropriations subcommittee, I shared Senator Cochran's concerns, but honestly hoped that the problem he highlighted would be corrected before we were faced with final passage of the conference report on FDA reform. While the conference report before us today does provide some relief in fiscal years 2001 and 2002 from the earlier Senate language, I am still disappointed that more progress was not achieved to inject a greater dose of realism into the expectations of the FDA authorization committees of the House and Senate.”