With the passage of the healthcare reform bill by the U.S. House of Representatives over the weekend personalized medicine is closer to becoming a part of the national healthcare agenda.
HR 3590, as passed in the House on March 21 by a 219-to-212 vote and which cleared the Senate in December, will include a section creating an independent Patient-Centered Outcomes Research Institute charged with conducting research that informs the public and healthcare providers about the comparative risks and benefits of marketed drugs, devices and medical products. The Institute’s research will also look at the utility and effectiveness of medical products and services in various subpopulations differentiated by race, ethnicity, sex, age, comorbidities as well as genetic and molecular subtypes.
President Barack Obama is expected to sign the healthcare reform bill into law today. The Senate is scheduled to vote on a companion bill of proposed changes made by House Democrats to the main healthcare reform legislation. This bill passed in the House 220-211. The Senate is slated to vote on this bill by March 27. Despite these remaining processes and potential hurdles, as a dozen states plan to challenge the constitutionality of the healthcare reform bill in the courts, chances are good that the bill, including the personalized medicine-friendly provisions within the comparative effectiveness research initiatives, will become law.
HR 3590 also instructs for establishment of a 15-member methodology committee that will be responsible for developing and improving the science and methods of comparative clinical effectiveness research. Members of this committee will be experts from various fields, including genomics and biostatistics.