Public Comments

10/27/2015

A Letter of Support to urge swift confirmation of Robert Califf as FDA Commissioner

The Honorable Lamar Alexander, Chairman, Committee on Health, Education, Labor, & Pensions, United States Senate, Washington, DC  20510 

The Honorable Patty Murray, Ranking Member, Committee on Health, Education, Labor, & Pensions, United States Senate, Washington, DC  20510

 

Dear Chairman Alexander and Ranking Member Murray,

On behalf of the 70 undersigned organizations, representing diverse stakeholders, dozens of diseases, and millions of Americans, we are writing to urge the swift confirmation of Robert Califf, M.D., as commissioner of the Food and Drug Administration (FDA).

We applaud Acting Commissioner Ostroff’s stewardship of the agency but believe that the opportunities upon us necessitate strong, permanent leadership at FDA. The agency regulates 25 cents of every dollar spent by American consumers, and its work has a profound effect on our collective health and well-being. With user fee negotiations underway, landmark biomedical legislation moving through Congress, and precision medicine advancing at a rapid clip, FDA needs a confirmed, permanent leader who can skillfully harness these opportunities and ensure that the agency continues to effectively achieve its mission for the American people.

Dr. Califf is that leader. He is a world expert in the design of clinical trials that are driven by sound science and patient need. He is also a skilled manager, having founded the world’s largest academic clinical research organization, which has completed nearly 1,000 clinical trials at over 37,000 sites in 65 countries.[1] Through that work, Dr. Califf has acquired decades of real-world experience running and evaluating clinical trials. He also maintains a deep understanding of the fast-moving science and the diverse stakeholders in government, academia, industry, and the patient community.

Becoming commissioner would be the culmination of a career dedicated to delivering the best care to patients. As a leader of the Clinical Trials Transformation Initiative (CTTI), Dr. Califf consistently brought the voice of patients and their caregivers to the fore. He was an active participant in the planning and execution of the FDA’s Mini-Sentinel project to develop an active safety surveillance system for medical products. He also served as a co-principal investigator of the coordinating center for PCORnet, the National Patient-Centered Clinical Research Network, an initiative to transform clinical research by engaging patients, care providers, and health systems to advance medical science and improve healthcare. These are but a few of the examples of Dr. Califf’s commitment to the needs of patients.

We are at a transformative moment in science. Breathtaking opportunities to improve health and save lives are emerging from innovations in the science of patient input, precision medicine, immuno-therapies, whole-genome sequencing, gene editing, and mobile health technology, among others. FDA has begun to take advantage of these opportunities and, with a visionary leader like Dr. Califf who can adeptly navigate the transitions ahead, the agency can maintain and grow this momentum. We must seize the moment to move these innovations across the regulatory finish line to awaiting patients. 

With 10,000 diseases and only 500 cures, there is much work to do, and Dr. Robert Califf is the leader FDA needs now. A swift confirmation process will enable him to help the agency continue its powerfully important work that patients are counting on. 

 

Respectfully,

FasterCures, a center of the Milken Institute

Accelerate Brain Cancer Cure

Accelerated Cure Project for Multiple Sclerosis

Addario Lung Cancer Medical Institute

Adenoid Cystic Carcinoma Research Foundation

Alliance for Aging Research

Alliance for Lupus Research

Alpha-1 Foundation

American Heart Association

Association of Clinical Research Organizations

BCM Families Foundation

Bonnie J. Addario Lung Cancer Foundation

Cancer Research Institute

Celiac Disease Foundation

Citizens United for Research in Epilepsy

COPD Foundation

Cure AHC

Cure SMA

CureHHT

Cutaneous Lymphoma Foundation

Dysautonomia International

Dystonia Medical Research Foundation

FH Foundation

Fight Colorectal Cancer

Foundation Fighting Blindness

Foundation for Mitochondrial Medicine

Foundation for Prader-Willi Research

Friedreich's Ataxia Research Alliance

Friends of Cancer Research

Gastroparesis Patient Association for Cures and Treatments

Genetic Alliance

Geoffrey Beene Foundation

Glaucoma Research Foundation

Hepatitis Foundation International

International Myeloma Foundation

Kids v. Cancer

Leukemia & Lymphoma Society

LUNGevity Foundation

Lupus Research Institute

LymeDisease.org

Lymphangiomatosis & Gorham's Disease Alliance

Melanoma Research Alliance

MLD Foundation

MPN Research Foundation

Multiple Myeloma Research Foundation

Muscular Dystrophy Association

Myotonic Dystrophy Foundation

National Alopecia Areata Foundation

National Brain Tumor Society

National Multiple Sclerosis Society

National PKU Alliance

New York Stem Cell Foundation

Parent Project Muscular Dystrophy

Pediatric Congenital Heart Association

PFO Research Foundation

Phelan-McDermid Syndrome Foundation

Progeria Research Foundation

Prostate Cancer Foundation

Reflex Sympathetic Dystrophy Syndrome Association

Research!America

Rett Syndrome Research Trust

Sjögren's Syndrome Foundation

Society of Women's Health Research

Solving Kids' Cancer

T1D Exchange

The diaTribe Foundation

The Hide and Seek Foundation

The Nicholas Conor Institute

USAgainstAlzheimer's

Wake Up Narcolepsy

 

                                         



[1] Duke Clinical Research Institute at a Glance, http://dcri.org (accessed Oct. 12, 2015).

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