[Congressional Record (Bound Edition), Volume 153 (2007), Part 20]
[Extensions of Remarks]
[Page 27731]
[From the U.S. Government Publishing Office, www.gpo.gov]




                              ON H.R. 3580

                                 ______
                                 

                        HON. DENNIS J. KUCINICH

                                of ohio

                    in the house of representatives

                       Thursday, October 18, 2007

  Mr. KUCINICH. Madam Speaker, I opposed H.R. 3580, a bill to 
reauthorize the Prescription Drug User Fee Act (PDUFA), because it 
failed to address the fundamental drivers of the high cost of 
pharmaceuticals, the pharmaceutical industry's deplorable safety 
record, and their lack of accountability.
  The bill ignores the single biggest conflict of interest at the FDA. 
The pharmaceutical industry pays hundreds of millions of dollars every 
year to the Food and Drug Administration, which is tasked with 
regulating them. The result is that the FDA has a relationship with 
industry that treats them more like a customer than an entity in need 
of oversight and evaluation. A 2002 Government Accountability Office 
report found that ``Our analysis of FDA data found that a higher 
percentage of drugs has been withdrawn from the market for safety-
related reasons since PDUFA's enactment than prior to the law's 
enactment . . .'' Furthermore, FDA staff morale has declined. The GAO 
found that ``FDA's attrition rates for most of the scientific 
occupations involved in its drug review process are higher than those 
for comparable occupations in other federal public health agencies and 
the remainder of the federal government.'' A Consumer Reports poll in 
April 2007 found that 67% of customers ``are concerned that much of the 
FDA's funding comes from the drug industry.'' This bill actually 
increases the amount the drug companies pay to the FDA. To ensure 
independence, the drug approval process should be funded by Congress.
  Second, the bill passed on a rare opportunity to address ways in 
which the pharmaceutical industry makes profits at the expense of 
health. An early version of the bill gave the FDA authority to ban 
Direct to Consumer advertising for three years, a practice which has 
repeatedly proven to influence drug use based on reason other than the 
merits of the drug. This bill contained only authority to assess 
penalties which pale in comparison to the profit to be made from 
running the ads.
  Another opportunity lost was to address the failure of the industry 
to put out new drugs that are substantially different from drugs that 
are already on the market, but which are less profitable because their 
patent monopolies are running out. Requiring clinical trials to compare 
new drugs not only to placebos but to existing drugs would, for the 
first time, give a clear indication of how useful the proposed drug is. 
It would also therefore provide a powerful incentive for the industry 
to focus its resources on truly innovative drugs instead of spending 
copiously on marketing to sell more profitable but less beneficial 
drugs. This bill gives lip service to these head-to-head trials when it 
should require them.

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