ADVOCACY

The Regenerative Medicine Advocacy Agenda

In addition to the broader health care reform, medical research and comparative effectiveness research debates, the regenerative medicine community should advocate on issues specific to facilitating research and commercialization of regenerative technologies.

Our advocacy strategy includes:

  • Research into funding policies that support necessary research in universities as well as in private companies;
  • A responsible and predictable regulatory policy to ensure that safe and effective products reach patients as soon as possible; and
  • A market-based reimbursement system that rewards innovation and will ensure patient access to new products.

Research Agenda

The Alliance will have the necessary expertise to work with National Institutes of Health (NIH), the Department of Defense (DoD) and other agencies to identify and recommend research priorities, as well as to advocate for funding and programmatic support from Congress.  The Alliance will also work to identify and advocate for new funding sources from Congress and relevant agencies.

Regulatory Agenda

A regulatory landscape that appropriately balances risk and benefit is critical to development of regenerative medicine products.

Specific questions to be resolved by the Food and Drug Administration (FDA) include:

  • whether regenerative medicine technologies should be regulated like other biologics and devices (and if not, what are the relevant differences);
  • how to use existing and developing clinical testing and imaging techniques and technologies to determine the safety of regenerative medicine products;
  • what standards should be used to determine the safety and efficacy of new products; and
  • the importance of the proposed clinical indication of the new product on the regulatory pathway.
     

The Alliance will establish a dialogue with FDA to ensure communication and input into agency actions. 

Reimbursement Agenda

As regenerative medicine technologies mature and more products get closer to marketability, the community needs to lay the groundwork for a favorable reimbursement climate to help ensure that Medicare as well as private insurers cover and pay for regenerative medicine products. 
Issues are likely to include:

  • determining what evidence of improved care and cost effectiveness payers will be looking for when making coverage and payment decisions and
  • providing input into those evaluations, as well as developing strategies for companies to obtain that information prior to product marketing.
     

The Alliance will establish a dialogue with Centers for Medicare and Medicaid Services (CMS) and private insurers to ensure communication and input into agency/insurer decision-making.

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The Alliance for Regenerative Medicine
2099 Pennsylvania Ave., NW
Washington, DC 20006
info@alliancerm.org

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