Regulatory Focus™ > News Articles > Health, Defense and Industry Officials to Discuss Regulatory Challenges of Blood Products

Health, Defense and Industry Officials to Discuss Regulatory Challenges of Blood Products

Posted 14 March 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) is planning to hold a meeting along with members of industry and various and diverse government agencies in April to work through issues related to the donation of blood and the regulation of blood products.

The 10-11 April workshop, entitled "Application of Advances in Nucleic Acid and Protein Based Detection Methods to Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations," is intended to discuss how new developments might be leveraged to better detect deficiencies in donated blood products.

Six topics in particular will receive attention at the meeting, FDA said:

  • blood safety and infectious agents
  • advances in blood-borne pathogen detection
  • molecular DNA-based typing of blood cell antigens
  • highly multiplexed technologies in blood donor screening
  • bioinformatics, data analysis, and data management issues
  • perspectives in developing multiplex devices for donor screening


Throughout 2012 and 2013, FDA has been issuing new guidance documents to reflect advances in technology and understanding regarding disease transmission risks. In June 2012, for example, FDA released new guidance on how to test for Creutzfeldt-Jakob Disease (CJD) in response to a new understanding that even small amounts of a blood derivative (albumin) could transmit the disease.

Other recent developments include regulators re-evaluating blood donation rules, issuing new plasma donation standards, new blood donation criteria to reduce the transmission of malaria, the approval of a pooled blood plasma product, and new guidance to better screen for syphilis.

Other reports have also weighed on regulators in recent months. A Wall Street Journalreport in 2012 noted the increasing risks of blood donations contaminated with bacteria, which have led to dozens of deaths in recent years. That report led to calls for FDA to reassess its requirements for testing for contaminated platelets, but has not yet resulted in any new guidance or standards.

The new meeting could potentially address those platelet testing concerns and lead to new recommendations for the blood donation industry.

Unusual Combo of Stakeholders

The various stakeholders involved are one indication that the meeting's outcomes could have a wide impact. Scheduled attendees include the US Department of Defense (DOD), Department of Health and Human Services (DHHS), the National Institutes of Health (NIH), medical device industry group AdvaMed, the American Association of Blood Banks (AABB), and America's Blood Centers.

Though the cast of attendees may seem odd, FDA regularly brings in agencies like DOD to consult on product changes that could have military or national security implications. For example, DOD officials were involved in a 2012 meeting regarding hydroxyethyl starch (HES) products commonly used to prevent the onset of low blood volume. The product, in addition to being used on civilians, is used in combat zones to stabilize wounded soldiers.


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