– September 22, 2010

Washington, DC —The Alliance for Regenerative Medicine (ARM), the political voice for regenerative medicine, today announced the introduction of the bi-partisan Regenerative Medicine Promotion Act of 2010 in the U.S. House of Representatives. ARM praised its sponsors for crafting a comprehensive plan to bring promising new therapies to market and promote global leadership in the field. The Act provides for the formation of the first national strategy for regenerative medicine in United States history. The field is of national significance because of its acknowledged potential to cure or dramatically diminish the effects of many diseases, including chronic conditions such as diabetes; cardiovascular and neurodegenerative disease; cancer; and traumatic injury. ARM members are in Washington, D.C., today meeting with members of Congress as part of the 2010 International Regenerative Medicine Day. The event comprises a simultaneous legislative day in the U.K., to highlight the importance of regenerative medicine as a global industry of the future. In addition to articulating its agenda and advocating for enactment of the Regenerative Medicine Promotion Act, ARM will discuss the necessity of NIH-funded human embryonic stem cell research, recently denied in a ruling by Chief Judge Royce C. Lamberth of the Federal District Court for the District of Columbia. Several Members of Congress have begun pushing for action to legalize such funding as a means of trumping the courts.

“This timely legislation represents the first coordinated effort by the regenerative medicine industry to reach out to Congress, and is the culmination of many months of effort to define our priorities and articulate the promise of regenerative medicine,” said John Walker, Chairman of ARM. “The Act provides a foundation for enduring U.S. leadership in regenerative medicine in the face of accelerating competition and ensures that Americans will have access to the best medical treatments available in the future,” Mr. Walker said.

“Among the sources of regenerative cell lines are those derived from human embryonic cells. These should not be excluded from scientific research and the promise they hold for creating cures for intractable diseases,” added Mr. Walker.

The Regenerative Medicine Promotion Act calls for the formation of a multi-agency Regenerative Medicine Coordinating Council within the Department of Health & Human Services (HHS) as well as establishes grants to accelerate the availability of life-saving regenerative medicine products. It additionally supplies funding for critical regulatory research at the Food & Drug Administration (FDA) and provides for reporting on federal activities in regenerative medicine.

“We are grateful to the lead co-sponsors of the Act, Rep. Diana DeGette [D-Colorado] and Rep. Mike Castle [R-Delaware], for crafting legislation that formalizes federal agency cooperation in translational research and supplies the mechanisms to bring promising regenerative medicine products to the market more efficiently,” said Michael Werner, Esq., Executive Director of ARM and a Partner at Holland & Knight.

Major provisions of the Regenerative Medicine Promotion Act of 2010 include:

  • Creation of the federal Regenerative Medicine Coordinating Council at HHS that will set national priorities for research and development, accomplishing the coordination of more than a dozen federal agencies and numerous individual NIH Institutes that fund or regulate an aspect of regenerative medicine. The provision additionally directs the Council to include community stakeholders in priority setting.
  • Establishment of grants for research, including grants for academic researchers conducting company-sponsored research and for academic-corporate research collaborations designed to support filing of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application.
  • Funding for companies to develop regenerative medicine products.Funding for the FDA to perform regulatory research, which the agency has formally requested in its FY 2011 budget request made by Commissioner Hamburg.
  • A comprehensive study of federal research activities.