By Lisa Seachrist
WASHINGTON — FDA reform hit the Senate floor Friday when members voted 89-5 to invoke cloture and initiate debate on the FDA Modernization Act of 1997, S. 830.
The move brings the bill, which reauthorizes the Prescription Drug and User Fee Act (PDUFA) and enacts FDA reform measures, to the floor and limits debate to eight hours. The Senate is scheduled to vote on the legislation late Tuesday afternoon.
"The magnitude of this vote went far beyond bipartisan support for this bill; it was a rout," said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO). "People clearly understand that this is a very thoughtful, reasonable and moderate bill."
The legislation, which was introduced by Labor and Human Resources chairman Jim Jeffords (R-Vt.), went through mark-up on June 18, but was kept from the Senate floor because Jeffords and ranking minority member Sen. Edward Kennedy (D-Mass.) couldn't come to a time agreement limiting amendments and debate before Congress recessed for the month of August.
The bill was held up largely by Kennedy, who expressed serious concerns about issues surrounding cosmetics and medical device labeling. However, as Congress reconvened, Senate Majority Leader Trent Lott (R-Miss.) notified his colleagues he intended to ask the Senate to invoke cloture and force the bill to the floor.
"Usually when you have a cloture vote, you are hoping for 61 senators to vote in favor," Feldbaum said. "The industry was able to fight back the charge, sometimes scurrilous charges, that this bill lowered the agency's standards."
While the bill appears to have strong bipartisan support, Health and Human Services Secretary Donna Shalala sent a letter to Jeffords noting the administration had some concerns.
In a letter dated Sept. 5, Shalala said the FDA and the committee have reached agreement on some of the most contentious issues, including the dissemination of information by manufacturers and the regulation of health claims. But she noted four issues remained that "have the potential for jeopardizing our mutual goal of timely reauthorization of PDUFA and passage of constructive, bipartisan FDA reform."
Shalala included federal preemption of regulation of over-the-counter drugs and cosmetics, determining substantial equivalence for new medical devices and a provision eliminating the requirement for the FDA to disclose the environmental impact of new products. Shalala also maintained that PDUFA triggers undercut the Balanced Budget Agreement.
In her letter, she said if the bill were to remain in its current form, she "would be forced to recommend to the president that he veto this legislation." Shalala, however, added she thought all the issues could be resolved. *