By Turna Ray
NEW YORK (GenomeWeb News) – With the passage of the healthcare reform bill by the US House of Representatives over the weekend personalized medicine is ever closer to becoming a part of the national healthcare agenda.
H.R. 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. The non-profit institute will be charged with conducting research that informs the public and healthcare providers about the comparative risks and benefits of marketed drugs, devices, and medical products.
Specifically, with regard to personalized medicine, 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, co-morbidities, as well as genetic and molecular subtypes.
"For personalized medicine, this vote is historic," Amy Miller, public policy director at the Personalized Medicine Coalition, told GenomeWeb Daily News sister publication Pharmacogenomics Reporter this week. "It represents the first time that the principles of personalized medicine have been passed by both houses of Congress."
President Barack Obama is expected to sign the healthcare reform bill into law on March 23. Following that, the Senate is scheduled to vote on a companion bill of proposed changes made by House Democrats to the main healthcare reform legislation. This so-called "reconciliation side car" bill passed in the House 220-211. The Senate is slated to vote on this bill by Saturday, 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 high that the bill, including the personalized medicine-friendly provisions within the comparative effectiveness research initiatives, will become law.
Originally, the section on CER in the House version of the bill did not contain language specifically on genomic subpopulations. However, it seems the House listened to the suggestions of personalized medicine proponents, such as NIH Director Francis Collins and members of the Personalized Medicine Coalition, to ensure that CER initiatives in the healthcare reform bill included research into genomically defined subpopulations.
In addition to the creation of the Patient-Centered Outcomes Research Institute, H.R. 3590 instructs for the 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.
Senate Majority Leader Harry Reid (D-Nev.) has publicly stated that there are sufficient votes in the Senate to pass the reconciliation side car bill. In the mean time, Republican Senators are planning to offer amendments to the bill. However, since any changes to the bill will require it to return to the House for a vote on the revisions, Senate leaders have expressed they will attempt to keep the bill "clean."
A more detailed version of this article is available on Pharmacogenomics Reporter.