Americans rely more than ever before on life-enhancing and life-saving pharmaceuticals. Growing concern about the way the Food and Drug Administration monitors drug risks and decides whether to let the public know about emerging risks — highlighted by the painkiller Vioxx three years ago and the diabetes drug Avandia today — obliges Congress to do whatever it can to improve public safety. The broad-based FDA legislation that’s making its way through Congress offers the biggest opportunity for important reforms. Other initiatives must also be taken.

In May, I reintroduced a proposal to improve the study of medical treatments, including the effectiveness and safety of drugs on the market. The legislation would give researchers at federal agencies and university-based and other research organizations highly controlled access to data on hospitals, physicians and prescription drug benefits that are provided to
Medicare beneficiaries while strictly protecting patient privacy.

There’s tremendous potential for improving the public safety by making this rich source of information available to experienced and credentialed researchers. Drug trials often include only a few hundred subjects. These trials are no match for the wealth of information that’s available after a drug is on the market and millions of people start taking it. The Medicare data initiative would tap that valuable information and dramatically benefit public safety and public health. It would do so in a way that makes sure the strongest safeguards are in place to protect privacy and confidentiality.

Medicare processes 500 million claims for benefits every year, and millions of prescriptions are filled annually through the Medicare Part D prescription drug benefit. Information about these benefits would be a tremendous resource for qualified health services researchers, and it would help them conduct rigorous studies on the safety and effectiveness of various medical treatments.

Researchers also could help policymakers better understand why services that we know can help people maintain good health are not being used and to develop policies to promote their use.

The new bill, the Access to Medicare Data Act of 2007, is based on legislation that Sen. Max Baucus (D-Mont.) and I introduced last year. The bill’s provisions would apply to the Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health and the Agency for Healthcare Research and Quality.

Researchers given access to information would be required to meet strict criteria, including significant expertise in analyzing the type and volume of data in question. They must also publish their methodology and findings, and they would be prohibited from selling the data or using it to create any commercial products. The researchers must have approval from a review board for the protection of human subjects that has exacting standards regarding the protection of identifiable information. They also must submit a data management plan that details measures that will be taken to safeguard the data and to protect the privacy of any beneficiary. Provider-specific information could not be made public.

The evidence piled up during the last three years and the experts who have weighed in, including the prestigious Institute of Medicine, all say that the nation’s surveillance of the safety of pharmaceuticals approved for use needs to be dramatically improved. The stakes are high for public safety and confidence in the marketplace of medicine. More and better study of the effects and efficacy of those drugs is key to reaching that goal.


Grassley is the ranking member of the Senate Finance Committee.