WASHINGTON May 24 The U.S. Senate on Thursday
showed near unanimous support for a bill that helps fund the
U.S. Food and Drug Administration, a regulatory powerhouse with
sweeping influence over the foods Americans eat and the
medicines they take.
The bill, which passed by a vote of 96 to 1, aims to speed
approval of new drugs and devices and ensure food safety. It
reauthorizes fees from companies like Johnson & Johnson,
Medtronic Inc and Roche Holding AG that help
speed FDA evaluation of new medical products prior to approval.
These so-called user fees could provide almost half of the
FDA's proposed $4.5 billion budget for next year. The FDA
regulates products that make up about a quarter of the U.S.
Similar legislation has passed a House committee with
bipartisan support and may move to the full House for a vote as
early as next week.
In a rare show of cooperation between Democrats and
Republicans, Senate leaders sped the bill through the
Democratically-controlled chamber, emphasizing its importance in
protecting consumer safety and promoting innovation in medicine.
"This bill is a shining example of what we can achieve when
we all work together," said Senator Tom Harkin, a Democrat from
Iowa and chair of the Senate committee that oversees the FDA.
Industry user fees, first enacted in 1992, give the FDA
millions of dollars annually to review new products for the U.S.
market but must be renewed every five years. The current version
is set to expire in September.
Starting this year, for the first time the FDA will also
collect fees from makers of generic drugs and of copycat
versions of complex biotech drugs, known as biosimilars.