May 24,2007

Grassley, Baucus Introduce Bill to Enhance Research on Pharmaceutical Safety and Effectiveness

WASHINGTON — Responding to growing concerns about the safety of pharmaceuticals, Sens. Chuck Grassley and Max Baucus introduced legislation today to improve the study of medical treatments, including the effectiveness and safety of drugs.

Their proposal would give researchers at federal agencies and university-based and other research organizations highly controlled access to data on hospital, physician and prescription drug benefits that are provided to Medicare beneficiaries.

“The situation that’s unfolding this week with the popular diabetes drug Avandia emphas the value of making this sort of rich source of information available to experienced and credentialed researchers,” Grassley said. “The drug trials that go on before the Food and Drug Administration approves a drug 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. This legislative initiative will tap that valuable information on behalf of public safety and public health. And, it does so in a way that makes sure the strongest safeguards are in place to protect privacy and confidentiality.”

“Knowledge is power, and this bill will empower our health system to serve Americans better,” said Baucus. “The secure and efficient sharing of Medicare’s vast data among a number of Federal agencies will enable researchers to accurately examine the safety and effectiveness of many treatments patients receive. More eyes might have helped us spot a situation like we learned about just this week with the FDA’s handling of the diabetes drug Avandia. This bill provides for this information-sharing with no other goal than to promote the public’s health and the public good.”

Medicare processes 500 million claims for benefits every year, and millions of prescriptions are filled annually through the new Medicare prescription drug benefit. Grassley said 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.

Grassley and Baucus said that researchers could help policy makers 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, for example.

The Access to Medicare Data Act of 2007 is based on similar legislation, S.3897 – the Medicare Data Access and Research Act – that was introduced last September by Grassley and Baucus. The provisions would apply to the Food and Drug Administration, the Centers for Disease Control, 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 which have 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.

Grassley is Ranking Member and Baucus is Chairman of the Senate Committee on Finance, which is responsible for Medicare legislation and oversight.