108th Congress

Prescription Drug Comparative Effectiveness Act

H.R. 2356, S. Con. Res. 95, S. 1926, S. 2445

Background

As the cost of prescription drugs has increased, several Members of Congress, most notably Representatives Thomas H. Allen (D-ME) and Jo Ann H. Emerson (R-MO) and Senator Hillary Rodham Clinton (D-NY), have advocated independent research comparing drugs and other therapies that are used to treat the same illness or condition.

The Agency for Healthcare Research and Quality (AHRQ) is the Federal agency specifically mandated through the Food and Drug Modernization Act of 1997 (P.L. 105-115) to conduct research on comparative effectiveness and safety of drugs, biological products, and devices. Congress broadened this authority through the Healthcare Research and Quality Act of 1999 (P.L. 106-129), which requires AHRQ to 1) conduct state-of-the-art research, 2) provide objective clinical information to clinicians, patients, pharmacists, and others, and 3) improve the quality of health care while reducing costs by focusing on appropriate use of these products and prevention of adverse events. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (P.L. 108-173), which became law on December 8, 2003, authorized $50 million for AHRQ to conduct comparative clinical effectiveness studies.

The National Institutes of Health (NIH) is the primary Federal agency that conducts and funds medical research to improve human health. Within this broad mandate, NIH conducts and supports a range of research comparing specific types and methods of drug therapy. Recent findings include:

• Results from the Women’s Health Initiative that estrogen plus progestin hormone therapy in postmenopausal women can increase the risk of heart disease and breast cancer
• A study published by the National Heart, Lung, and Blood Institute concluding that newer treatments for high blood pressure were no more effective than diuretics
• Research supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases that found that combining two bone-building treatments produced no significant improvement in bone mineral density than if the drugs were used separately

Provisions of the Legislation/Impact on NIH

• The Director of NIH, in coordination with AHRQ, would have been required to conduct methodologically sound research comparing prescription drugs that account for high levels of expenditures or use by individuals in federally funded health programs with other drugs and treatments used for the same disease or condition. The goal of the research would have been to develop valid scientific evidence regarding the comparative effectiveness, cost-effectiveness, and, where appropriate, comparative safety of those drugs.
• The Director of AHRQ, after taking into consideration NIH research in this area, would have been required to use evidence-based practice centers to conduct this research. AHRQ, in consultation with the Food and Drug Administration, NIH, and other stakeholders, would have been required to develop standards for the design and conduct of the studies.
• AHRQ would have been required to submit an annual report on the results of its activities to Congress, the Secretary of Defense, the Secretary of Health and Human Services, the Secretary of Veterans Affairs, the Administrator of the Centers for Medicare and Medicaid Services, the Director of the Indian Health Service, the Director of NIH, and the Director of the Office of Personnel Management.
• No later than 1 year after the completion of a study, AHRQ would have been required to prepare a report on the results for health care practitioners and NIH.
• NIH would have been required to post the reports described above on its Web site as well as use other means to facilitate access by practitioners.
• The legislation would have authorized $50 million to NIH and $25 million to AHRQ for fiscal year (FY) 2004 and such sums as may be necessary for subsequent fiscal years.

Other legislation regarding comparative effectiveness studies included:

• S. Con. Res. 95, the Senate’s FY 2005 budget resolution, contained a Sense of the Senate resolution that $75 million be used in FY 2005 and subsequent years to fund research on the comparative effectiveness and safety of prescription drugs and other treatments.
• H.R. 5252 and S. 2933, the Fair Access to Clinical Trials Act, would have allowed the proceeds from penalties from violations of the Act to fund comparative effectiveness studies.
• S. 1926, the Support Our Health Care Providers Act of 2003, would have required AHRQ to conduct and support comparative clinical effectiveness research.
• S. 2003, the Health Information for Quality Improvement Act, contained language similar to H.R. 2356.
• S. 2445, the Direct to Consumer Prescription Drug Advertising Act of 2004, would have required NIH to conduct research comparing the effectiveness and safety of prescription drugs offered under the Federal Employee Health Benefits Program, relative to other prescription drugs used to treat the same condition or disease.

Status and Outlook

H.R. 2356 was introduced by Representative Allen on June 5, 2003, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 108th Congress.

S. Con. Res. 95 was introduced by Senator Don Nickles (R-OK) on March 5, 2004, and was reported out of the Senate Committee on the Budget the next day. The measure passed the Senate by a vote of 51 to 45 on March 12. The House struck the text of the resolution, inserted their language, and passed the bill by unanimous consent on March 29. A conference report (H. Rept. 108-498) was filed on May 19 and passed the House by a vote of 216 to 213 as H. Res. 649 the same day. No further action occurred on this legislation during the 108th Congress.

S. 1926 was introduced by Senator Debbie A. Stabenow (D-MI) on November 21, 2003, and was referred to the Senate Committee on Finance. No further action occurred on this legislation during the 108th Congress.

S. 2445 was introduced by Senator John R. Edwards (D-NC) on May 19, 2004, and was referred to the Senate Committee on Health, Education, Labor and Pensions. No further action occurred on this legislation during the 108th Congress.

Although no further action occurred on the legislation described above, there were several attempts during the 108th Congress to modify other related legislation. For example, during debate of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (P.L. 108-173), Senator Clinton introduced an amendment to include language very similar to H.R. 2356; this amendment failed by a vote of 43 to 52. During debate of the FY 2005 appropriations measure for Labor, Health and Human Services, and Education (H.R. 5006), Representative Allen introduced and then withdrew an amendment to provide full funding for comparative effectiveness studies authorized by P.L. 108-173. Regarding the reports accompanying the FY 2005 appropriations legislation, S. Rept. 108-345 contained language authorizing $15 million for AHRQ for FY 2005, and H. Rept. 108-636 contained language encouraging AHRQ to continue and strengthen its efforts in comparative clinical effectiveness research, as authorized by P.L. 108-173.