11 June 2012
Division of Dockets Management
Food and Drug Administration (HFA-305)
5630 Fishers Lane – Rm 1061
Rockville, MD 20852
RE: Federal Register (FR) Docket No. HHS – OPHS – 2012-0003 "Request for Information (RFI) on Design of a Pilot Operational Study to Assess Alternative Blood Donor Deferral Criteria for Men Who Have Had Sex With Other Men (MSM)"
Dear Dockets Manager:
AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.
AABB appreciates the opportunity to provide comment on the process that the Department of Health and Human Services (HHS) has undertaken. While this submission to the docket is not for the purpose of proposing a new study it may be that AABB institutional members will make such a submission. AABB also appreciates the funding that has been made available for the studies already ongoing, as described in the Federal Register Notice.
We note that several studies described on page 14803 of the FR notice are currently ongoing. AABB member institutions are involved with these studies. Additional work by the AABB Interorganizational Quarantine Release Errors Task Force is underway. The current blood donor history questionnaire being evaluated by the National Center for Health Statistics is the work product of the AABB Donor History Task Force (DHTF). Another study described in the FR Notice further explores whether MSM accurately assess their risk in order to self-defer when appropriate. Many of the centers working on the two projects that are a part of major National Heart, Lung, and Blood Institute funded studies (REDS-II and REDS-III) are also represented on AABB’s Transfusion Transmitted Diseases Committee (TTD). Member experts from the DHTF and the TTD committee have many times advised the AABB Board of Directors and shaped the policies and public positions of the AABB on the issues being evaluated.
Most recently AABB, along with America’s Blood Centers and the American Red Cross, publicly restated its longstanding position at the June 2010 meeting of the Advisory Committee for Blood Safety and Availability on the issue of deferral of MSM. AABB supports the use of rational, scientifically-based deferral periods that are applied fairly and consistently among blood donors who engage in activities posing similar risks.
AABB maintains its recommendation that FDA amend the indefinite deferral currently in place for a male who has had sex with another male to a 12-month deferral. This change in policy would bring the deferral period for MSM into line with the deferrals for other high-risk sexual behavior. For example, the current deferral period for individuals who have had sexual contact with an individual with HIV or viral hepatitis is 12 months. In each of these cases, all donors with infections will be positive by either or both methods routinely used to screen donated blood; e.g. serology (antibody) tests and/or nucleic acid amplification testing (NAT). The current “window period” from the time an individual is infected and the time screening tests would detect infection – approximately 9 days for HIV, 7 days for HCV, and ≤ 40 days for HBV (depending on the sensitivity of the HBsAg and HBV NAT assays) – falls well within a one-year deferral period.
AABB believes that HHS agencies should be committed to evaluating the data that will be contributed from the ongoing studies/projects described in the FR Notice in an effort to move forward with the change in the deferral period for MSM to 12 months. It should not be a requirement to have elaborate pre- and postdonation testing schemes for prospective MSM donors since their risk will be no higher than other prospective donors who are currently deferred for 12 months and who are not subject to this additional testing (e.g. prospective donors who have had direct sexual contact with someone known to be infected with HIV or HBV).
Language in the FR Notice describes a theoretical concern that persons at increased risk for known sexually transmitted diseases might also be at increased risk to acquire sexually and blood transmitted infections that may emerge in the future and for which no donor screening tests exist. This has long been a stated concern of HHS agencies and we believe the proposed studies will not address this concern. It is very difficult to evaluate an unknown risk and it seems the issue will render moot the results of any of the ongoing or solicited studies.
AABB appreciates the opportunity to provide these comments and we encourage HHS agencies to evaluate data from current ongoing studies and take action, rather than embark on further studies.
|M. Allene Carr-Greer|
Director, Regulatory Affairs
|Louis M. Katz, MD|
Chair, Transfusion Transmitted Diseases Committee
|Susan N. Rossmann, MD, PhD |
Chair, Donor History Task Force