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Bill Would Ease Distribution of Off-Label Data

Bill Would Ease Distribution of Off-Label Data

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 Mack has not withdrawn his original bill, although its provisions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

The Proposed Reform


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