DRUG SAFETY -- (Senate - May 22, 2007)
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.
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.