President Obama announced during his 2015 State of the Union Address that he is launching a new “precision” or personalized medicine initiative to advance personalized, effective therapies for the American public. As reported by the Personalized Medicine Coalition, President Obama stated:
“21st century businesses will rely on American science, technology, research and development. I want the country that eliminated polio and mapped the human genome to lead a new era of medicine – one that delivers the right treatment at the right time. In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable. Tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes – and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”
The President’s announcement revisits his interest in personalized medicine. As a junior senator, President Obama introduced S. 3822 (109th) titled “Genomics and Personalized Medicine Act of 2006” (attached here). The overall goal of the Act was to realize the promise of personalized medicine by expanding and accelerating genomics research, to improve the accuracy of disease diagnosis, and to increase the safety of drugs and to identify novel treatments. Several of the key provisions of the Act were to:
The bill was not enacted, but was reintroduced on May 28th, 2010 by Congressman Patrick J. Kennedy (D-RI) and Congresswoman Anna Eshoo (D-CA) as H.R. 5440 (111th) “Genomics and Personalized Medicine Act of 2010” (copy here). The Act deviated slightly from President Obama’s previous bill. Briefly, the goals of the 2010 bill were to be realized through the following initiatives.
Similar to President Obama’s bill, the 2010 Act was not enacted, but several of the initiatives from the bills have been implemented. For example, in October of 2013, FDA released “Paving the Way for Personalized Medicine FDA’s Role in a New Era of Medical Product Development” that outlines FDA’s plan to implement a regulatory framework that supports the co-development of companion diagnostics and therapeutics as well as genomic-based medicine. In addition, FDA recently announced that it is requesting public input on its proposed regulation of next generation sequencing (“NGS”) as outlined in its discussion paper “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests – Preliminary Discussion Paper.” FDA’s proposal for NGS is reviewed in our prior posts of December 28th, 2014 and January 4th, 2015.
Whatever the details, the President’s announcement signals significant government assistance for personalized medicine. It’s good to have friends in high places.