Washington, DC —
In a victory for consumers, the Senate today passed the “Food and Drug
Administration Revitalization Act” sponsored by Senator Ted Kennedy (D-Mass.)
by a vote of 93 to 1.
The bill attempts to please both the
powerful pharmaceutical industry and consumer groups. It increases the amount of money the FDA
receives in fees from drug makers to speed the approval of new drugs, and
includes language to protect consumers from unsafe prescription drugs.
Over the next five years, the bill will
increase by $225 million the amount of drug industry user fee money dedicated
to drug safety.
“Congress is telling the FDA that they
must put safety first,” said U.S. PIRG Consumer Health Care Advocate Paul
Brown. “The American public will no longer tolerate dangerous and deadly drugs like
Vioxx, Paxil, and Accutane approved by an agency that has been much too cozy
with the industry it is supposed to be regulating.”
The Senate bill gives the FDA new powers
to issues fines to drug companies if they fail to do follow-up safety studies,
or if they air false or misleading TV ads.
In a rebuff to the drug industry, an amendment by Senator Charles
Grassley (R-Iowa) to substantially increase those fines passed by more than a
two to one margin. Unfortunately, an
amendment by Senators Richard Durbin (D-IL.) and Jeff Bingaman (D-NM) to
reduced conflicts-of-interests on FDA advisory committees failed to pass on a
tied vote, 47 to 47.
“Even without the stronger conflict-of-interest
amendment, this bill is a step in the right direction,” said Brown. “For too long the ‘D” in the FDA has stood
for ‘dysfunctional’. This legislation
will begin to change that by refocusing the agency on its original mission of
ensuring that American consumers receive safe medicines.”
The drug safety provisions were added to must-pass
prescription drug user fee legislation that provides nearly $400 million or 20
percent of the Food and Drug Administration’s $1.5 billion budget.
The House is scheduled to debate similar
legislation in the Energy and Commerce Subcommittee on Health by the end of
May, and both Houses are expected to pass drug safety/prescription drug user
fee legislation by the end of July.
U.S. PIRG is the federation of state
Public Interest Research Groups. State
PIRGs are non-profit, non-partisan public interest advocacy organizations.
