Statements on Introduced Bills and Joint Resolutions

Floor Speech

STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS -- (Senate - May 24, 2007)

BREAK IN TRANSCRIPT

By Mr. GRASSLEY (for himself and Mr. BAUCUS):

S. 1507. A bill to amend title XVIII of the Social Security Act to provide for drug and health care claims data release; to the Committee on Finance.

Mr. GRASSLEY. Mr. President, I am pleased to join my colleague from Montana, Senator Baucus in introducing the Access to Medicare Data Act of 2007. This legislation is based on S. 3897, the Medicare Data Access and Research Act, which Senator Baucus and I introduced in the 109th Congress.

The bill we are introducing today establishes a framework under which Federal agencies within the Department of Health and Human Services would have access to Medicare data, including data collected under the Medicare prescription drug benefit, to conduct research consistent with the agencies' missions. The legislation also creates a process through which university-based and other researchers who meet a strict set of requirements would be permitted to use Medicare data for research purposes.

As I said last year, Medicare data, particularly prescription drug data, are an immense resource that can support critical health services research, especially research on drug safety. Examining Medicare data could help the FDA identify situations, such as the one involving Vioxx more quickly and to take quick action to protect the public's health and safety.

But the FDA isn't the only place that this important research can and should occur. The study issued earlier this week in the New England Journal of Medicine regarding the prescription medicine Avandia clearly demonstrates that point. Researchers from the Cleveland Clinic found that there are serious problems with Avandia a drug that has been on the market for 8 years and is used to treat diabetes. Specifically, the researchers believe that taking Avandia increases the likelihood that a diabetic patient will have a heart attack and maybe even die. The researchers came to this conclusion after reviewing information from 42 clinical trials. Making Medicare data available to researchers like those at the Cleveland Clinic will offer another avenue for them to take in conducting research like this.

I want to be clear that, similar to last year's bill, the Access to Medicare Data Act won't permit just anyone to get the Medicare data. In applying for data access, researchers at universities and other organizations will have to meet strict criteria. They must have well-documented experience in analyzing the type and volume of data to be provided under the agreement. They must agree to publish and publicly disseminate their research methodology and results. They must obtain approval for their study from a review board. They must comply with all safeguards established by the Secretary to ensure the confidentiality of information. These safeguards cannot permit the disclosure of information to an extent greater than permitted by the Health Insurance Portability and Accountability Act of 1996 and the Privacy Act of 1974.

I am hopeful that we can get this bill approved soon. I, for one, don't want to be standing here next year talking about another Vioxx or another Avandia. We need to improve and create more opportunities for the government, as well as other researchers, to spot potential trouble with a drug more quickly and to take swifter steps to protect the public's health and safety. The Access to Medicare Data Act will help us accomplish that critical goal.

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