KENNEDY ON AVANDIA SAFETY CONCERNS
Too often, it takes a crisis to move Congress to act on an urgent national need. We have already had crisis after crisis on drug safety, and yesterday we learned of another. A report published in the New England Journal of Medicine shows 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 national priority, this latest report puts the issue beyond any doubt.
Two weeks ago, by an overwhelming vote of 93 to 1, the Senate approved strong and comprehensive legislation to enable the Food and Drug Administration to do what needs to be done to improve drug safety, and we're working now with our colleagues in the House to see that this legislation is signed into law as soon as possible.
Yesterday's report was based on an analysis of 42 clinical trials. The report concluded that use of Avandia could raise the risk of heart disease. I commend the authors for their skill and persistence - but we must ask this basic question -- why did the American public have to wait more than 8 years and depend on a group of independent scientists to conduct this study, before we learn of a major safety concern with this drug? Why wasn't the FDA doing this kind of analysis? Why aren't companies required to undertake additional safety tests if there are unanswered questions about their products?
The answer is that the FDA does not have the resources and the information technology 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.
The FDA Revitalization Act passed by the Senate establishes a strong new system of active surveillance for drug safety problems after a drug is on the market. Today, the FDA has ample authority to require pre-market studies to ensure that drugs going on the market are safe and effective. But the FDA has no such authority to require adequate oversight of drug use after marketing begins.
Instead, FDA relies on a sporadic and ineffective system of passive reporting of adverse events. Our legislation changes that by requiring the FDA to link electronic health care databases to answer questions about the safety of drugs on the market.
Tens of millions of patients will be included in this oversight. It will mean better and faster identification and assessment of drug risks. We need to make certain that any unforeseen risks associated with any drug are detected as quickly as possible, so that effective protections can be implemented before lives are needlessly put at risk. Our legislation provides the resources needed to make this happen by adding to the fees that drug companies are required to pay, and by devoting the additional funds to drug safety.
Some critics of the FDA have called for an end to user fees. They seem to think that, without the user fees, millions of dollars in additional resources will magically appear to aid the FDA in its work. Sadly, wishing won't make it so. No magic will replace the resources that would be lost if the user fees are allowed to lapse. The right choice for drug safety is to do what our bill does - renew the user fees and make sure they are used for drug safety, not just drug reviews.
Our legislation gives FDA the authority to require a drug company to conduct any post-approval study necessary to answer a question that the FDA's own surveillance system won't answer. This power is essential. The New England Journal authors noted the limitations of their own analysis and suggested that a large prospective trial might be the best way to get the answers we need about Avandia.
Some of the clinical trials used in the New England Journal report were found in a registry of clinical trial results that Glaxo voluntarily maintains. That's better than some companies have done, but a set of scattered registries are often of little use to patients and health care professionals. 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 the public health. The FDA also needs the authority to take action where needed. The bill does more than merely give the FDA the tools it needs to identify and assess the risks of drugs. When new information requires new labeling information or a medication guide, the FDA is given the authority to order it.
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 shouldn't have to depend on requests. The bill gives FDA the authority to require those measures, and impose civil money penalties to enforce them.
Our legislation also gives the FDA broad discretion to require safety information to be included in advertising for any drug. It ensures that this information will be presented in a clear, conspicuous and neutral manner. No longer will advertisers be able to gloss over basic safety information by distracting viewers with pretty scenes in the background. Safety information will have to be presented in the manner appropriate to what it is - potentially life-saving information.
We don't know yet the right action to take on Avandia. Perhaps the drug should be withdrawn. Perhaps the best course is a strong warning for doctors and patients, with significant new safety information required in advertising. But whatever the right actions are, the FDA will have the authority to require them, once the legislation is enacted.
Our legislation will help make the FDA once again the gold standard for protecting the public health. It should not take a new crisis to persuade Congress to act. I look forward to working with our colleagues in the House to see that this needed legislation is signed into law without delay.