12 April 2010
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
RE: Docket No. FDA–2009–N–0247, 12 March 2010, “Transparency Task Force”, Request for Comments
Via electronic submission: http://www.regulations.gov/
Dear FDA Dockets Manager:
AABB is an international association dedicated to advancing transfusion and cellular therapies worldwide. Our members include more than 1,800 hospital and community blood centers and transfusion and transplantation services as well as approximately 8,000 individuals involved in activities related to transfusion, cellular therapies and transplantation medicine. For over 50 years, AABB has established voluntary standards for, and accredited institutions involved in, these activities. AABB is focused on improving health through the advancement of science and the practice of transfusion medicine and related biological therapies, and developing and delivering programs and services to optimize patient and donor care and safety.
AABB appreciates the opportunity to respond to this docket and provide comments on ways in which FDA can increase transparency between the agency and regulated industry. In addition, AABB would like to state appreciation for the willingness of FDA to provide liaisons to many of the committees that function within AABB. Public workshops are also an important way in which members of the transfusion and cellular therapies community can interact with FDA. It is through interactions such as these that FDA gains valuable insight as well as access to data that ultimately ensure guidance recommendations not only contain the agency’s current thinking but also reflect current processes being used by industry and respect the needs of those populations presenting to donate.
A review of the transcripts from the three listening sessions held for members of regulated industry reveals common concerns that are reiterated in these comments. In order for the agency’s current considerations / thinking on interpretations of regulations to be apparent / transparent to regulated industry FDA must move to update out-of-date guidance in a timely manner. The guidance development process is not always transparent. It moves very slowly at times and there is often no meaningful explanation provided for the delay of guidance that is known to be in-process. Examples are provided.
- A draft guidance providing proposals for testing, product disposition, and donor deferral and reentry for HIV and HCV nucleic acid testing published in July, 2005. The recommendations were welcome and yet five years later cannot be implemented due to the fact that final recommendations have not been published. Establishments (regulated industry) continue to struggle with management of donors who are presumably eligible for reentry, yet remain in the ineligible donor pool. There is no apparent reason for the delay in publication of the final recommendations.
- A draft guidance document related to variant Creutzfeld-Jakob disease (vCJD) risk exposure in France was published August, 2006. Responses to the draft guidance were not controversial and it is expected that publication of the final recommendations will include recognition of version 3.0 of the Donor History Questionnaire (DHQ) originally recognized by FDA in a guidance document published October 2006. The vCJD guidance document has not been published with final recommendations and this has precluded a public recognition of FDA acceptance of v 3.0 of the DHQ which contains enhanced safety features to be used when evaluating donors for eligibility to donate blood. There is no apparent reason for the delay, but the ramifications of the delay could be significant.
AABB recommends that FDA respond to regulated industry with meaningful information when there is a delay in publication of final recommendations following publication of a draft guidance document. AABB also recommends that, absent numerous and controversial comments to the docket, the final recommendations should be published reasonably quickly. Regulated industry is given a timeline for responding to the docket established for draft guidance, if the response is to be considered in formulation of the final recommendation; this timeline implies a schedule for publication of the final recommendations.
AABB strongly supports initiatives that improve the safety of patients and donors and stands ready to interact with FDA as necessary. Questions concerning these comments may be directed to M. Allene Carr-Greer, Director, Regulatory Affairs, firstname.lastname@example.org.
M. Allene Carr-Greer, MT(ASCP)SBB
Director, Regulatory Affairs