By Lisa Seachrist
WASHINGTON — In a session devoted solely to moving the FDA reform bill, S. 830, forward, the U.S. Senate entertained amendments to the bill and ultimately voted 98 to 2 to accept the version presented by Labor and Human Resources Chairman Jim Jeffords.
That version, the manager's amendment, represents changes to the original legislation that came out of committee markup as well as a number of compromises negotiated since June 18.
In light of the overwhelming vote, Jeffords (R-Vt.) and Sen. Edward Kennedy (D-Mass.) agreed to limit final debate to eight hours, and Senate Majority Leader Trent Lott (R-Miss.) scheduled a final vote for 3:45 p.m. today.
The agreement to limit debate bypassed the need for another cloture vote as well as the concomitant 30 hours of debate over passage of the final bill.
The move lessens the likelihood that delay in the reauthorization of the Prescription Drug and User Fee Act will result in layoffs of the 600 employees funded by the program.
"The overwhelming votes on cloture and the motion to proceed are testament to the fact that this is a sound bill with bipartisan support," said Sen. Orrin Hatch (R-Utah).
S. 830 took a particularly tortuous route to its final consideration. Kennedy vehemently opposed a national uniformity provision for cosmetics and over-the-counter drugs, threatened a filibuster, and forced the Senate to take the first of two cloture votes just to bring the bill to the floor. Kennedy and Jeffords were able to compromise on that issue.
However, the Clinton administration had concerns over language in the bill that would compel the FDA to evaluate lower-risk medical devices solely in reference to the use that the manufacturer included in the label. Kennedy and Sen. Jack Reed (D-R.I.) spearheaded the effort to address the administration's concern and forced a second cloture vote to limit the debate on accepting the manager's amendment.
Kennedy and Reed introduced an amendment that would have inserted a provision permitting the FDA to widen the scope of its review when the agency deemed that the label included false or misleading information.
"This is the only provision in the entire bill that the Secretary of Health and Human Services identified as one that could threaten the public health and a veto," Kennedy said. "This is an extremely important issue and we must not let it threaten the entire bill."
Sen. Dan Coats (R-Ind.) pointed out the legislation being considered was written by Paul Wellstone (D-Minn.), and "he can hardly be considered anti-consumer."
"We have a situation where the clock is ticking, we have bipartisan support, and yet we meet procedural delay after delay after delay," Coats said. "We are not attempting to threaten public health; we are attempting to find a way to efficiently approve these lower-risk devices."
The Senate voted 65-35 to kill the Reed-Kennedy amendment.
The House Commerce Committee will take its three FDA bills to markup on Thursday. *