[Congressional Record Volume 152, Number 125 (Friday, September 29, 2006)]
[Extensions of Remarks]
[Page E1949]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




            STATEMENT ON IOM RECOMMENDATIONS FOR FDA REFORM

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                          HON. ROSA L. DeLAURO

                             of connecticut

                    in the house of representatives

                       Friday, September 29, 2006

  Ms. DeLAURO. Mr. Speaker, I wanted to bring to my colleague's 
attention a New York Times editorial that comments on the 
recommendations by the Institute of Medicine (IOM) for reforming the 
Food and Drug Administration (FDA). The editorial contends that IOM has 
wisely called for a significant increase in financing and personnel to 
correct the imbalance between the funds and staff devoted to approving 
new drugs and the smaller resources available for post-market 
surveillance. The editorial also observes that, even when problems 
arise, the agency virtually has no authority to regulate drugs on the 
market unless there is overwhelming evidence that they are unsafe.
  The IOM report, The Future of Drug Safety, confirms what many of us 
in Congress have been arguing all along--that FDA authority needs to be 
strengthened and that the agency relies too heavily on negotiations 
with industry. The recommendations outlined in the IOM report reflect 
the initiatives that many of us in Congress already have proposed, 
including: requiring post-market surveillance of drug products; 
requiring a moratorium on direct-to-consumer (DTC) advertising; and 
eliminating conflict-of-interests involving members of FDA advisory 
committees.
  This report provides independent verification that Congress must act 
to implement the changes that are needed at the FDA. Congress will have 
the opportunity next year to make an immediate impact when it considers 
the reauthorization of the Prescription Drug User Fee Act (PDUFA). 
Congress should strongly consider IOM's PDUFA recommendation that a 
portion of the user fees be diverted to specific safety-related 
performance goals.
  I ask that the New York Times editorial be inserted in the Record.

               [From the New York Times, Sept. 28, 2006]

                   Prescription for a Stronger F.D.A.

       A prestigious advisory group has put its weight behind 
     criticism that the Food and Drug Administration is pitifully 
     weak when it comes to removing dangerous prescription drugs 
     from the market. Last week, a panel appointed by the 
     Institute of Medicine, part of the National Academy of 
     Sciences, issued a slew of recommendations to strengthen the 
     beleaguered F.D.A. as it struggles to regulate a huge array 
     of medications whose ill effects sometimes show up only after 
     years of wide use.
       The institute's report, which was requested by the F.D.A., 
     deplores the big imbalance between the money and staff 
     devoted to approving new drugs and the much smaller resources 
     for monitoring drugs after they are on the market. The 
     imbalance results in part from the pharmaceutical industry's 
     providing user fees that pay for expediting the approval 
     process, but not for monitoring the aftereffects. Worse yet, 
     even when it spots a problem, the agency has very little 
     power to regulate drugs on the market unless there is 
     overwhelming evidence that they are unsafe, which is seldom 
     the case.
       Although the nation is mired in budget deficits, the 
     institute was wise to call for a large increase in financing 
     and personnel for this crucially important regulator of 
     public health. If Congress is too stingy to ante up more 
     money, it should at least divert some of the drug industry's 
     user fees to surveillance after a drug's approval.
       The panel calls for the F.D.A. to evaluate the safety and 
     effectiveness of drugs that are truly new, not just copycats, 
     at least once every five years. It wants the agency to be 
     given explicit power to compel post-marketing studies and to 
     impose fines, injunctions and withdrawals to enforce its 
     decisions. In a departure from conventional wisdom, the panel 
     also urges the F.D.A. to require that a substantial majority 
     of the members of each of its advisory panels be free of 
     significant financial involvement with companies whose 
     interests might be affected. That undercuts the agency's 
     claims that there are not enough experts without ties to the 
     drug industry.

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