[Congressional Record (Bound Edition), Volume 153 (2007), Part 10]
[Senate]
[Pages 13433-13434]
[From the U.S. Government Publishing Office, www.gpo.gov]




                              DRUG SAFETY

  Mr. KENNEDY. Mr. President, I wish to address the Senate about a very 
important subject. Too often it takes a crisis for Congress to take 
action on a national need. We have had crisis after crisis on drug 
safety, and yesterday we learned of another. A report published in the 
New England Journal of Medicine showed that the diabetes drug Avandia 
may increase the risk of heart attacks and death. If further evidence 
were needed that improving drug safety is an urgent priority, 
yesterday's report puts the matter beyond doubt. The Senate has 
approved strong and comprehensive legislation to improve drug safety. 
That proposal should be taken up by the House and enacted without 
delay.
  Yesterday's report was based on an analysis of clinical trials 
conducted by a team of physicians and scientists, and I commend them 
for their skill and perseverance. Why isn't FDA doing this kind of 
analysis, and why aren't companies required to undertake additional 
safety tests if there are unanswered questions about their products?
  The simple answer is, the FDA does not have the resources to conduct 
these analyses itself, and it doesn't have the authority needed to 
require companies to perform them. The legislation the Senate recently 
approved corrects both of these major flaws.
  Our legislation requires FDA to link electronic health care databases 
to allow for better, faster identification and assessment of safety 
problems. The bill adds to the fees that drug companies are required to 
pay and devotes new funds to drug safety.
  Unforeseen risks of a drug must be caught as quickly as possible so 
that effective protections can be implemented before more lives are 
needlessly put at risk, and our legislation makes that happen.
  The New England Journal recommended a large prospective trial as the 
best way to get the answers we need. FDA should have clear authority to 
require such trials, and our bill provides it.

[[Page 13434]]

  Some trials studied in the journal report were included in a registry 
that Glaxo voluntarily maintains. The Senate bill requires the results 
of clinical trials to be made available to the public in a single, 
easily accessible database. That will help patients get information 
about the medicines they take, and it will help scientists identify 
drug safety problems faster.
  Information alone is not enough to protect public health. FDA needs 
the authority to take action where needed. Right now all FDA can do 
after approval is request a labeling change or request a medication 
guide or request patient labeling or request a review of drug 
advertising. Safeguarding the lives of American patients should not 
have to depend on requests. Our bill gives the FDA the authority to 
require those measures and impose civil monetary penalties to enforce 
them.
  Our legislation will make FDA, once again, the gold standard for 
protecting public health. It should not take a new crisis to bring 
Congress to act. I look forward to working with our colleagues in the 
House to see that this legislation is signed into law without delay.

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