By Lisa Seachrist
WASHINGTON — The Senate once again overwhelmingly voted to limit debate in its efforts to bring S. 830 — its bill reauthorizing the Prescription Drug and User Fee Act and enacting broader FDA reforms — to the floor for passage.
In a 94-4 vote, the Senate invoked cloture to prevent a threatened filibuster by Sen. Edward Kennedy (D-Mass.) and officially limit debate to thirty hours before the body can vote to accept and pass Labor and Human Resources Committee Chairman Jim Jeffords' (R-Vt.) legislation.
After coming to a compromise on a provision that would have allowed for federal preemption of state regulation of cosmetics and over-the-counter drugs, the bill has been stymied by issues concerning medical devices. In particular, Kennedy has problems with a provision that would limit the agency's scope of review of 510(k) applications to the labeled indication presented by the manufacturers.
During a one hour debate, Sen. Christopher Dodd (D-Conn.) noted that the provisions arise from the fact that "FDA has inappropriately expanded its scope of review."
Jeffords added that it is ludicrous to expect manufacturers to anticipate all of the potential ways a doctor may choose to use a device and that such a requirement would bring the approval of medical devices to a grinding halt.
"I am not interested in having FDA investigate every possible use of a device," Kennedy said. "But this bill removes the agency's authority to ask a manufacturer to show a device is safe and effective for what is likely to be its primary use."
Kennedy cited the case of a surgical laser used to cut tissue being outfitted with a trigger that would allow a physician to use the laser to treat prostate cancer. Because lasers have already been approved to remove tissue, the manufacturer could submit a 510(k) application claiming that the new laser is substantially equivalent to the old lasers and have the label indicate that it is only for the removal of tissues, when the device is most likely going to be used to treat prostate cancer.
"The FDA should have the authority to require the manufacturer to prove the laser is safe and effective in treating prostate cancer," Kennedy said. "This legislation doesn't allow that. And we should be able to provide language that will allow them to."
At the end of the debate, Kennedy pledged to work with Jeffords to find language that would address his concerns, noting, "We could dispose of this bill as soon as we are finished with the [Department of] Interior appropriations."
However, a Kennedy spokesperson said that if the issues are not resolved, Kennedy will use any and all means to delay the bill. *