PPTA member companies are committed to providing safe and effective plasma protein therapies that remain available to the patients who rely on them often as life-saving treatments. The Association monitors and has engaged Federal agencies on emergency preparedness policy. During a pandemic influenza outbreak, natural disaster, shortage of blood or blood products, or other emergency, a number of resources exist for stakeholders who may have concerns about the safety and/or availability of certain plasma protein therapies. Below is a list of resources for public use in the event of an emergency.
An international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies, AABB is committed to improving health by developing and delivering standards, accreditation, and educational programs that focus on optimizing patient and donor care and safety. PPTA serves as an organizational member of the Interorganizational Task Force on Domestic Disasters and Acts of Terrorism which was formed in January 2002 to help make certain that blood collection efforts resulting from domestic disasters and acts of terrorism are managed properly and to deliver clear and consistent messages to the public regarding the status of America's blood supply. AABB maintains a Disaster Operations Handbook, Overview of Response Plan, and Hospital Supplement.
The Interorganizational Task Force on Pandemic Influenza and Blood Supply was formed in 2005 to help ensure that blood needs can be met in the event of an influenza pandemic. A Pandemic Influenza Update, Background Paper, Issues Outline, and Planning Checklist are available.
American Red Cross (ARC)
Supplying about 40% of the nation's blood supply, ARC also provides emergency preparedness information.
Department of Health and Human Services (HHS) - Office of Assistant Secretary for Health (ASH)
The ASH Division of Blood and Tissue Safety and Availability provides information on blood and tissue preparedness and response; its Advisory Committee on Blood and Tissue Safety and Availability has discussed "Considerations for Blood Products Emergency Plans and Use."
HHS - Office of the Assistant Secretary for Preparedness and Response (ASPR)
ASPR was created under the Pandemic and All Hazards Preparedness Act (PAHPA) in the wake of Katrina to lead the U.S. in preventing, preparing for, and responding to the adverse health effects of public health emergencies and disasters. ASPR focuses on preparedness planning and response; building Federal emergency medical operational capabilities; countermeasures research, advance development, and procurement; grants to strengthen the capabilities of hospitals and health care systems in public health emergencies and medical disasters; and providing Federal support to augment state and local capabilities during an emergency or disaster, e.g. medical professionals through the National Disaster Medical System. Offices within ASPR include the Biomedical Advanced Research and Development Authority (BARDA), which provides an integrated and systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies, and the Office of Preparedness and Emergency Operations (OPEO), which is responsible for developing operational plans, analytical products, and training exercises to ensure the preparedness of ASPR, HHS, the Federal government, and the public to respond to and recover from domestic and international public health and medical threats and emergencies. PAHPA has been reauthorized as the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), which clarifies and adds to the Food and Drug Administration's (FDA) existing authority, including refinements to existing Emergency Use Authorization requirements, governmental pre-positioning, new authorities for emergency use of medical products, and shelf-life extension.
FDA - Office of Counterterrorism and Emerging Threats (OCET)
OCET's mission is to facilitate the development and availability of safe and effective public health emergency medical countermeasures (MCMs) and establish policies to safeguard medical products from adulteration and prevent disruption of supplies as a result of terrorist activities. OCET provides strategic leadership and coordination for FDA's counterterrorism and emerging threat portfolios and works to identify and resolve complex scientific and regulatory challenges facing medical MCM development, approval, availability and security. Collaborating with the Center for Biologics Evaluation and Research (which regulates plasma protein therapies), the Center for Drug Evaluation and Research, the Office of Regulatory Affairs, the Office of Crisis Management and Federal partners, OCET coordinates FDA's MCM initiative (MCMi), facilitates relevant intra- and inter-agency counterterrorism communications and coordinates emergency use authorization activities. The 2014 MCMi Regulatory Science Symposium was held on June 2-3 to provide a forum for the exchange of scientific ideas for MCM development and evaluation, communicate progress on regulatory science efforts related to the development and advancement of MCMs, facilitate innovative directions and inform stakeholders on MCM-related scientific progress and accomplishments.
FDA - Office of Crisis Management (OCM)
FDA's focal point for coordinating emergency and crisis response activities involving FDA-regulated products or in situations when FDA-regulated products need to be utilized or deployed, OCM coordinates intra- and inter-agency activities related to crisis management and emergency preparedness and response. FDA maintans webpages on When and Where to Report Emergencies involving FDA-regulated products and on Biologic Product Security.
PPTA Contributions to Pandemic Preparedness
- Comments to CDC on Interim Infection Control Guidance on 2009 H1N1 Influenza for Personnel at Blood and Plasma Collection Facilities (2009)
- Comments to FDA on Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus (2009)
- Statement on Safety of Plasma Protein Therapies and Swine Influenza Virus (2009)
- Attended Department of Defense, Defense Health Board meetings (2008)
- Presentation by LCDR Thomas C. Luke Naval Medical Research Center Department of Viral and Rickettsial Pathogens: Convalescent Plasma Therapy: Back to the Future? at PPTA Source Planning Meeting (2008)
- Statement on Safety of Plasma Protein Therapies and H5N1 Viruses (2007)
- Letter to HHS (2007)
- Presentation on Influenza Pandemic Preparedness Activities (2006)
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