Archive for August, 2011

Legislative Specifications Would Create a Path Forward for Personalized Medicine

August 23, 2011

The Personalized Medicine Coalition has a long history of working with Congress on the Genomics and Personalized Medicine Act (GPMA); a bipartisan bill first introduced by Senators Obama and Burr in 2007.  The original bill was designed to take full advantage of our federal investment in the Human Genome Project by putting policies in place to enable personalized medicine.  Subsequent versions of the bill have not gone far enough to realign the health care system with personalized medicine.  In an effort to see a more effective version of GPMA introduced in this Congress – one that would move personalized medicine forward and would enjoy community support — PMC members developed a set of legislative specifications for Congressional consideration that are complementary to previous versions of GPMA.  We’ve asked Congresswoman Anna Eshoo to consider including them in her new version of the bill.

These recommendations include a range of important regulatory and policy concepts that can have a meaningful impact on advancing the discovery of and access to personalized medicine products.  They also echo important themes that emerged at the PMC’s Capitol Hill briefing in May.

Specifically, we propose codifying the Department of Health and Human Services’ Personalized Healthcare Initiative and providing the Secretary with an advisory committee populated by experts inside and outside of the government. We also reiterate the importance of ensuring adequate personalized medicine expertise and input on various federal advisory committees and within policy proposals.

Sponsors of personalized medicine products have had challenges taking drug-diagnostic combination products through the Food and Drug Administration (FDA). These experiences suggest that innovators need a predictable regulatory path at FDA so we propose an office for personalized medicine to coordinate therapeutic and diagnostic review, and enforce review timelines for both.

While the path from regulatory approval at FDA to adequate coverage and payment is clear (and usually predictable) for therapeutics, adequate coverage and payment for diagnostics can be long, complicated and frustrating.  To ensure that patients have access to the latest personalized medicines and diagnostics, we suggest policies at the Centers for Medicare and Medicaid Services that will ensure timely coverage and reimbursement for them.

Finally, to ease business model barriers, and incentivize the types of relationships that are the hallmark of personalized medicine, we suggest extending the qualifying therapeutic discovery tax credit from health care reform and expanding it to include personalized medicine companies.  We also suggest a new research and development tax credit to entities developing personalized medicine products.

We look forward to working with members of Congress in both chambers and in both parties to see that the Genomic and Personalized Medicine Act is introduced and signed into law.

The details of the legislative specifications can be found here.

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