By Lisa Seachrist
WASHINGTON — The Senate version of FDA reform, FDA Modernization and Accountability Act of 1997, garnered strong bipartisan support and passed the Senate Labor and Human Resources Committee in a 14-4 vote Wednesday.
The bill, which entered markup last week, uses the pending expiration of the Prescription Drug and User Fee Act (PDUFA) as the impetus for broader FDA reforms. And while the bill generated controversy in the areas of medical device reform, food labeling and drug compounding, PDUFA reauthorization as well as the biologics rewrite and fast-track drug approvals garnered consensus from both sides of the aisle.
"Fourteen to four is an excellent show of support," said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO). "The lack of controversy over our key provisions is really heartening -- it's an enthusiastic endorsement."
Sen. Jim Jeffords (R-Vt.), chairman of the Labor and Human Resources Committee, introduced wide-ranging FDA reform legislation, S. 830, early this month. While he used the Sept. 30 expiration of PDUFA to spur a number of FDA reforms, his legislation avoided contentious issues like the time frames and hammers that doomed FDA reform in the 104th Congress. (See BioWorld Today, June 4, 1997, p.1.)
"This strong bipartisan vote shows that this is a moderate proposal which will ensure we have a strong FDA into the future," said Jeffords. "Should this bill pass it will be the first time in 30 to 40 years that Congress has had a complete review of FDA."
In addition to Sen. Barbara Mikulski (D-Md.) and Sen. Christopher Dodd (D-Conn.), who co-sponsored the legislation, Sen. Paul Wellstone (D-Minn.) and Sen. Patty Murray (D-Wash.) also crossed the aisle in order to give S. 830 its broad support. Mikulski has stated that keeping PDUFA reauthorization on track is vital, as layoff notices to the 600 employees the agency hired with PDUFA funds go out on August 2 if the bill has not been signed into law.
Sen. Edward Kennedy (D-Mass.) emphasized the pending deadline and argued that PDUFA should be reauthorized without any amendments attached to it. His pleas, however, fell on deaf ears.
A committee spokesman noted that S. 830 will see floor action shortly after the July Fourth holiday recess, as Senate Majority Leader Trent Lott (R-Miss.) has stated that PDUFA reauthorization and FDA reform are high priorities.
Wednesday's markup was notable in the fact that not a single issue associated with PDUFA, fast-track approval or the biologics rewrite was discussed. Instead the controversies focused mostly on food labeling and third-party review for medical devices.
"The main controversies centered on devices," Feldbaum said. "We really learned some things from the 104th Congress. We focused on getting broad support for our proposals."
Feldbaum also praised Jeffords and his staff for doing an "excellent job defusing issues that should not have been heated in the first place."
After the Senate votes on S. 830, the House will have to come up with its version of PDUFA and FDA reform. As yet, there has been no legislation introduced into the House.
"They have their own schedule," Feldbaum said. "I expect to see a bill very shortly. I just hope that it is easily reconcilable with the Senate bill."
Feldbaum also went on to note that the committee vote "marks eroding support for Kennedy's ideology." *