Archive for October, 2010

Closing the Book on SACGHS: What’s Next for Personalized Medicine Policy?

October 28, 2010

The loss of the HHS Secretary’s Advisory Committee on Genetics, Health and Society (“SACGHS”) will leave a void in the personalized medicine policy landscape.  Since its inception in 2002, the SACGHS has served a unique and important purpose—it was the central forum for identifying issues related to the use of genetic and genomic technologies.  In doing so, it has developed a high-profile public record of the challenges and promise of personalized medicine and provided all stakeholders and interested government agencies a consistent and multidimensional forum in which to raise and debate these issues.  Although some of the issues managed by this Committee will find homes in other existing federal advisory bodies, the Secretary and her constituents are losing a medium in which Administration policy could be addressed  with substantial public and private sector input. 

As we the members of the committee tried to develop a final letter to transmit to the Secretary containing our concluding thoughts and recommendations for further evaluation, it seemed as if with each additional point the Committee returned to the overarching recommendation that a body like SACGHS be designated to continue its work.

The creation of SACGHS filled an ever-widening void for crosscutting policy analysis and advice.  As a former counselor to the Secretary, I have remarked to curious inquiries that the decision not to renew the SACGHS charter is part of the natural cycle of the evolution of cutting-edge policy issues, such as genomics and personalized medicine and how each Administration chooses to address them.  Many have questioned the reasons behind this Administration’s decision to sunset the SACGHS, with suggestions that recent efforts moved beyond the scope of their charter, such as the report on gene patents.  Dr. Francis Collins, Director of the NIH, provided assurances that this was not the case and, as one of the “dissenters” from the recommendations of the gene patent report, I believe the open debate was reflective, as it should be, of the larger debate on that and other sensitive matters the Committee considered.

I believe there will be a new public forum to address the development of public policy related to personalized medicine.  There needs to be a consistent entity that convenes regularly to provide a public record of diverse views by experts and other interested stakeholders and to serve as the medium for cross-agency and cross-department consultations on these topics.  Even the most organized, expert and well-read Secretary needs advisors on emerging public policy challenges, and with issues as broad and technical as genomics and a government as big as ours, current and future government leaders  will benefit from a critical  base of advisors.

Sheila Walcoff is a Partner with McDermott, Will & Emery, LLP. She previously served as health and science policy counselor to HHS  Secretary Michael O. Leavitt.

FDA Releases Regulatory Science Framework

October 8, 2010

At a National Press Club luncheon on Wednesday, Food and Drug Administration (FDA) Commissioner Margaret Hamburg released a strategic framework for FDA’s initiative to improve regulatory science and to create a new office dedicated to it.

The framework, outlined in a paper titled “Advancing Regulatory Science for Public Health,” seeks to improve FDA’s ability to effectively evaluate and regulate emerging products in the genomics and personalized medicine field, among other fast-changing areas of health care innovation. The goal of this effort, Hamburg said, “is to reduce the gap between the advances in science and the practice of patient care.”

Commissioner Hamburg pointed to the need to utilize the breakthroughs in genomics and tailored therapies to improve patient care. In particular, the new initiative will seek to expand collaborations with industry, academia, and other government entities to improve product development process and speed. It is hoped that this will reduce the time currently needed to bring new innovations into clinical practice.

Recognizing that innovation is increasingly focused on personalized medicine, these changes are designed to open the door to smaller, shorter clinical trials for targeted therapies, to speed the approval of new drugs, especially cancer drugs, for individuals with specific biomarkers.

In the words of the Commissioner, the FDA wishes to pragmatically evolve regulatory science to enable “21st century medicine” and “move out of a one-size-fits-all” paradigm of regulation.

Timothy A. Swope is the Policy & Communications Analyst with the Personalized Medicine Coalition.

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