Statements on Introduced Bills and Joint Resolutions

Floor Speech

STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS -- (Senate - May 21, 2009)

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By Mr. REED (for himself and Ms. Mikulski):

S. 1142. A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising; to the Committee on Health, Education, Labor, and Pensions.

Mr. REED. Mr. President, today I introduce the Informed Health Care Decision Making Act of 2009. I am introducing this legislation along with my colleague Senator Mikulski because every American deserves to have the full information regarding drugs and devices prescribed by their provider.

Even though the amount of money spent to reach the public about drugs and devices is greater than five billion dollars annually, the most fundamental information--information about how well the drug or device actually works--is generally absent. In 2007, the Institute of Medicine conducted a workshop regarding the public's understanding of drugs and confirmed the importance for patients and physicians of having standardized and quantitative information about the product before making health care decisions.

Researchers at Dartmouth University have documented that replacing the current narrative information contained in drug advertisements with simplified, factual information, will enable patients to play an active role in health care decision making. In fact, similar to the nutrition facts boxes that are required on our Nation's packaged food supply, this research demonstrated that a drug facts box will actually help physicians make better health care choices.

If the research is not enough proof that this type of streamlined information will be beneficial, the Food and Drug Administration's, FDA, Risk Communications Advisory Committee, a committee specifically designed to counsel the agency on how to strengthen the communication of risks and benefits of FDA-regulated products to the public, unanimously recommended that the FDA adopt standardized, quantitative summaries of risks and benefits in a drug facts box format.

As such, the Informed Health Care Decision Making Act of 2009 would require the FDA to determine if the information provided in a drug facts box, or a similar format, would improve health care decision making by clinicians and patients, and report to Congress on that determination. If the report determines that a specific standardized, quantitative format would be beneficial, the FDA must issue regulations to implement the format.

Regardless of the FDA's determination, it is important for clinicians and patients to be able to compare the similarities, differences, benefits, and risks of drugs and devices. As such, the legislation would require the Agency for Healthcare Research and Quality to establish a multi-stakeholder process for developing and periodically updating methodological standards and criteria for comparative clinical effectiveness research. This would include standards and criteria for the sources of evidence and the adequacy of evidence that are appropriate for the inclusion of comparative clinical effectiveness information in labeling and print advertisements.

Upon completion of these standards, the legislation requires drug labels and print advertisements to include information on the clinical effectiveness of a product--compared to other products approved for the same health condition for the same patient demographic subpopulation--or a disclosure that there is no such information, if another product has not been approved for the same use. The potential of such a disclosure should be a powerful incentive for manufacturers to fund comparative effectiveness research.

It is my hope that as we embark upon meaningful health care reform, my colleagues will join me in supporting this bill and other initiatives to improve the health care decision making of both patients and clinicians.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

There being no objection, the text of the bill was ordered to be printed in the RECORD, as follows:

S. 1142

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