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November 16, 2015

Senator Lamar Alexander
Chairman
Committee on Health, Education, Labor, & Pensions
United States Senate
455 Dirksen Senate Office Building
Washington, DC  20510

Senator Patty Murray
Ranking Member
Committee on Health, Education, Labor, & Pensions
United States Senate
154 Russell Senate Office Building
Washington, DC  20510

Dear Chairman Alexander and Ranking Member Murray,

We, the undersigned, are writing to urge swift confirmation of Robert Califf, MD for the position of Commissioner of the Food and Drug Administration. The nation needs a strong leader with vision, passion, and experience. Dr. Califf is that leader, without peer.

There is a critical need for FDA to become a facile and responsive organization, in an age where innovation must be key in drug and device development, and in protecting the nation's food supply. The FDA’s structure was created in the 1970's and reflects outdated science and technology paradigms. Siloed divisions oversee drug, device, and biologics development. The information age, coupled with the phenomenal advances in genomic science, and technologies that are built on digital capabilities, demands leadership that understands the advantages of integration and collaboration throughout the agency and between the agency and stakeholders. That genetic and genomic technologies are classified as devices is reflective of a lack of understanding that new technologies will, in some instances, require new systems of oversight.

Most important to us, the undersigned, is an essential truth: the FDA in 2015 and beyond must include participants and patients as partners.  People are key partners in all aspects of health, and in all phases of the continuum in therapy and intervention development.

As you are aware, Califf was the executive committee co-chair of Clinical Trials Transformation Initiative from 2007 – 2015, where he strongly believed the patient voice was critical to improving the quality and efficiency of clinical trials and supported efforts of co-learning between academia, industry, clinical trial services organizations, institutional review boards, and patient representatives.  CTTI has been a leader in patient engagement from its inception, always including representatives of the health advocacy community as equal partners in its executive committee and steering committee, and hiring key personnel to support relationships in this area.  In 2013, CTTI made effort to increase the patient voice in the organization's work by engaging an additional 15 thought leaders from the advocacy organizations funding and operating clinical trials, which brought patient/caregiver voice to 20 % of its total membership – the largest presence of any group in the multistakeholder organization.  It also engaged patient representatives as project team leaders and members to disrupt the typically academic and/or industry-driven research model.   In 2014, with Califf's support, CTTI launched a project on best practices for effective engagement with patient groups around clinical trials, which released evidence–based recommendations and actionable solutions and tools in order to optimize research partnerships and demonstrate the value of patent group engagement in clinical trials in October 2015.

Prior to accepting his current position at the FDA, Dr. Califf was a principal investigator for the Coordinating Center of PCORnet, the nation's clinical research network, funded by the Patient Centered Outcomes Research Institute, where again he demonstrated a deep and innovative commitment to patient engagement by including representatives of the patient community in key positions of leadership and governance.  He was instrumental in developing PCORnet's first trial ADAPTABLE, which seeks to compare the benefits and harms of a low- and regular-strength daily dose of aspirin in patients diagnosed with heart disease. Dr. Califf ensured representatives of the patient community were essential partners in study design, conduct, and oversight.   

Dr. Califf was also the co-PI of NIH Collaboratory Distributed Research Network. It enables investigators to collaborate with each other in the use of electronic health data, while also safeguarding protected health information and proprietary data. It supports both single- and multisite research programs.  During his tenure he used the digital town hall he called "Grand Rounds" to repeatedly highlight the patient voice, particularly in project development and dissemination.

The confirmation of Robert Califf, MD for the position of Commissioner of the FDA will greatly benefit the very people who need an end to their suffering. In all of his positions of leadership, Dr. Califf leads with clarity and vigor, and a value for diverse stakeholder perspectives. He is very practical and pragmatic.  At the same time, he has great vision and compassion. He is the visionary leader we need to transform regulatory science to improve the health of all Americans.

Sincerely,

[Undersigned - see signatures here]

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