Monday, June 23, 1997
WASHINGTON - The full Senate will vote on S. 830, legislation that reauthorizes the Prescription Drug User Fee Act (PDUFA) and imposes incremental reforms on the FDA, soon after it returns from the July 4 recess, according to the staff of Senate Majority Leader Trent Lott. An affirmative vote would be an important step toward the first major modernization of drug and biologic regulation in three decades.
The Senate Labor and Human Resources Committee last week ignored the opposition of ranking Democrat Sen. Edward Kennedy (D-Mass.) and completed its outline of S. 830. The committee rejected Kennedy's attempt to add provisions that would have imposed civil penalties of up to $1 million on companies that failed to comply with commitments to conduct Phase IV trials as part of an accelerated approval. Kennedy asserted that some 25 percent of the post-approval trials requested by FDA are not completed.