WASHINGTON--Nancy L. Kasse-baum (R-Kan), chairman of the Senate Labor and Human Resources Committee, expects the Committee to complete action in late March on her bill to reform the US Food and Drug Administration (FDA). The bill would then be forwarded to the full Senate for a vote.
The measure, the FDA Performance and Accountability Act (S. 1477), includes a controversial section that would end the FDA policy that bans pharmaceutical companies from providing physicians with scientific reports on the off-label uses of FDA-approved drugs.
This provision was originally introduced last August as a separate bill by Sen. Connie Mack (R-Fla), Sen. William Frist (R-Tenn), a surgeon, and six other co-sponsors. It was later incorporated into Sen. Kassebaum's legislation.
A Kassebaum aide indicated that FDA officials have expressed concerns to committee staff about the off-label provision. "Their main concern is to what extent the free exchange of off-label uses would discourage companies from doing the research necessary to prove that an off-label use is actually safe and effective," the aide said.
Despite the FDA's concerns, Sen. Mack expects solid support for his provision from both parties. "The legislation is in the early stages of a long process, but the issue is one that should attract bipartisan support," he said in an interview.
Rep. Richard Burr (R-NC) has introduced a similar bill in the House, Sen. Mack said. Should the Senate pass an FDA reform bill, it would then go to the House for hearings and action.
Sen. Mack has not withdrawn his original bill, although its provisions are now part of Sen. Kassebaum's measure. Thus, should Sen. Kassebaum's bill fail, Sen. Mack could continue to pursue the original Mack/Frist bill.