Policy and Government Relations

Recent Activity

ARM Statement Regarding Potential Budget Cuts to the FDA and NIH

UK House of Lords Submission

Sweeping FDA Reforms Successfully Enacted

Policy and Legislation Overview

Regenerative Medicine Promotion Act

The Regenerative Medicine Promotion Act of 2011 (HR 1862) was introduced in the U.S. House of Representatives in April 2011, and has bi-partisan support. Reps. Brian Bilbray (R-CA) and Diana DeGette (D-CO) are the lead sponsors and have been joined by 15 other Members of Congress. Major provisions of the bill include: 

• requiring that the U.S. Government Accountability Office (USGAO) be responsible for strategic assessment of all federal agency activities related to regenerative medicine
• creating a multi-agency Regenerative Medicine Coordinating Council within the Department of Health and Human Services (HHS)
• establishing grant programs to accelerate the availability of life-saving regenerative medicine therapies and research tools
• funding of critical regulatory research at the FDA.

Supporting HR 1862 and its provisions is a major legislative focus of the Alliance for 2012 and beyond.

In addition, in September 2011 the U.S. House of Representatives Tri-Caucus (comprised of the Congressional Black Caucus, the Congressional Hispanic Caucus and the Congressional Asian Pacific American Caucus) hosted a briefing for Alliance leaders. The focus of the briefing was for the Alliance to educate congressional offices about the potential of regenerative medicine to treat currently unmet medical needs. Several congressional offices represented at the briefing have since become co-sponsors of HR 1862.

Human Embryonic Stem Cell Research Update

Regenerative medicine achieved a major milestone concerning federal funding of human embryonic stem cell (hESC) research when, in the spring of 2011, the U.S. Court of Appeals overturned an August 2010 preliminary injunction that, by a vote of 2-1, prohibited the federal government from funding research involving human embryonic stem cells. The court held that funding such research is not prohibited by a statute (known as the Dickey-Wicker Amendment) that prohibits federal funding of “research in which a human embryo or embryos are destroyed.” The court also held—contrary to the lower court—that enjoining hESC research would cause harm to the government significantly greater than the harm that the plaintiffs would suffer without an injunction. Thus, since that time, the NIH developed funding guidelines for researcher-grantees.

National Institute for Standards and Technology (NIST)

Supporting increased funding for the National Institute for Standards and Technology (NIST) regenerative medicine programs and the FDA are also legislative priorities for the Alliance. Positive news occurred in July 2011, when the House encouraged NIST to consider supporting standards and measurement work in regenerative medicine technologies under the Scientific and Technical Research and Services budget, which was increased by $10 million from 2011 to 2012. Additionally, the FDA received a $50 million budget increase in FY 2012.

National Institutes of Health Appoints Dr. Mahendra Rao

In August 2011 the National Institutes of Health appointed the esteemed human embryonic stem cell scientist Dr. Mahendra Rao as Director of the new Intramural Center for Regenerative Medicine (NIH-CRM). The NIH-CRM is an initiative to create a world-class center of excellence in stem cell technology on the NIH campus. Research at NIH-CRM will include induced pluripotent stem cells (iPSC), which have potential applications in many systems and organs of the body. A major goal for the center is to build upon existing NIH investments in stem cell research to advance translational studies and, ultimately, cell-based therapies in the NIH Clinical Center. The center will also serve as a resource for the scientific community, providing stem cells, as well as the supporting protocols and standard operating procedures used to derive culture and differentiate them into different cell types for research and potential regenerative therapies.