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:

“21^st 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 Genomics and Personalized Medicine Act

The President’s announcement revisits his interest in personalized medicine. As a junior senator, President Obama introduced S. 3822 (109^th) 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:

1. establish the Genomics and Personalized Medicine Interagency Working Group to expand and accelerate genetics and genomics research and translate such research into clinical and public health applications;
2. expand and accelerate research and programs to collect genetic and genomic data that will advance the field of genomics and personalized medicine;
3. develop a plan for a national biobanking research initiative;
4. expand efforts to increase knowledge about the interaction between genetics and the environment and about ways in which molecular genetic screening, diagnostics, and treatments may be used to improve the health and health care of racial and ethnic minority populations;
5. increase recruitment and retention of trainees in genetics and genomics;
6. ensure the adequacy of genetics and genomics training for diagnosis, treatment, and counseling of adults and children for both rare and common disorders; and
7. improve the safety, efficacy, and availability of information about genetic tests; animprove the oversight and regulation of genetic tests.

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 (111^th) “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.

1. To establish the Office of Personalized Healthcare within the Office of the Secretary to coordinate the activities related to genomics and personalized medicine of the Department of Health and Human Services and other relevant agencies and public and private entities. Selected initiatives would include the development of a long term strategic plan to advance personalized medicine and clarify and simplify the regulation of products used for personalized medicine.
2. To expand and accelerate research for genomics and personalized medicine by awarding grants to entities to increase and accelerate research and programs to collect, evaluate and disseminate genetic and genomic data. In addition, the Director of the National Institutes of Health, in consultation with the Director of the Centers of Disease Control and Prevention, would establish and maintain a national bio bank to advance the field of personalized medicine.
3. To establish an advisory committee to analyze current literature to expand and accelerate knowledge related to the clinical validity and utility of genomics and personalized medicine. The committee would, for example, develop processes for developing or adapting processes for recognizing promising new products for the use of personalized medicine.
4. To remove barriers to the implementation of personalized medicine will be studied through various avenues. The Secretary of Health and Human Services would have established a committee to carry out a comparative analysis of laboratory requirements to the end of reducing the redundancy. A committee also would be formed representatives of the private sector to examine barriers in research, regulation, and reimbursement to innovation, development, and implementation of medical product development for personalized medicine.

Waiting for the Details

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.

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