WASHINGTON, DC – March 13, 2017 – The Alliance for Regenerative Medicine (ARM) today issued the following statements on the Trump Administration’s nomination of Scott Gottlieb, M.D., as commissioner of the U.S. Food and Drug Administration (FDA).
ARM Chairman Robert Preti, Ph.D. said, “As a former practicing physician, FDA deputy commissioner and senior policy advisor for the Centers for Medicaid and Medicare Services, Dr. Gottlieb is a great choice to oversee the FDA’s mission of protecting public health and advancing innovation in the development of safe and effective new medicines for patients.”
ARM co-founder and executive director Michael Werner added, “Dr. Gottlieb is the right person to lead the agency at this time. With Dr. Gottlieb at the helm, we look forward to continuing our work with FDA to further establish a regulatory framework for regenerative medicine technologies, which include cell and gene therapies, and tissue engineering products. These are among the world’s most advanced technologies in development of new treatments and cures for our most intractable and debilitating illnesses, such as heart disease, cancer, diabetes, Alzheimer’s and Parkinson’s.”
Werner noted the recently enacted 21st Century Cures Act established a new Regenerative Medicine/Advanced Therapy product designation to optimize FDA approval pathways for regenerative medicine products.
About The Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 250 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit www.alliancerm.org.