From approving harmful drugs to letting the pharmaceutical industry
get away with murder, the Food and Drug Administration (FDA) seems
to be continually failing to get it right. And while the agency
may be trying to move in a positive direction, the attempts seem
short-lived.
According to Dr. David Graham and Senate Finance Committee Chairman
Charles E. Grassley, the FDA's new Drug Safety Oversight Board will
not increase the ability of the agency to remove unsafe prescription
drugs from the market and could actually hinder efforts to make
medications safer.
The Dynamic Duo
Graham -- who in November 2004 criticized
the FDA's ability to protect the public from harmful drugs --
blasted the structure of the membership of the board, noting the
panel is "severely biased in favor of industry" and that
"the FDA cannot be trusted to protect the public or reform
itself."
And in a letter to acting Commissioner Lester M. Crawford, Grassley
stated that the makeup of the board led him to conclude that, "What
we have here is nothing more than the status quo."
The 15-member board largely consists of FDA managers with some
input of the National Institutes of Health and the Department of
Veterans Affairs. The qualms Graham and Grassley have with the current
board arrangement is that 11 of the 15 voting positions of the board
are filled by senior FDA managers for the agency's Center for Drug
Evaluation and Research -- the very same office responsible for
reviewing and approving new drugs.
Additional concerns include:
- Most of the safety board's deliberations will be kept private.
- A two-thirds majority vote is required to recommend the FDA
take action on anything.
Need for a Change
Both Graham's and Grassley's disapprovals show that Congress may
not be satisfied with the FDA's actions and may press for a change
on pending legislation to create a more independent drug office.
In fact, Congress is already considering bills that would more
aggressively address drug safety: A bipartisan effort led by Grassley
and Sen. Christopher Dodd introduced a bill that would create a
board with far fewer ties to the FDA; however, opponents argue the
bill will focus far too much on the risks of a drug, and not its
benefits.
Medical
News Today June 13, 2005
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