Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T99-38 Print Media: 301-827-6242
August 17, 1999
Consumer Inquiries: 888-INFO-FDA
This guidance, a precautionary measure, asks blood centers to exclude potential donors who have spent six or more cumulative months in the U.K. between Jan 1, 1980, and December 31, 1996 from donating blood.
FDA's guidance was developed in parallel with Canada's health ministry, Health Canada, which today is issuing similar guidance for its blood establishments.
FDA expects blood centers to implement the new guidance over the next six months.
NvCJD, a fatal degenerative disease found almost exclusively in the United Kingdom (U.K.), has been linked to an outbreak of bovine spongiform encephalopathy (BSE) there. No evidence exists that the disease has been transmitted by blood transfusion, but current studies cannot exclude this possibility.
The risk of nvCJD from BSE exposure is unknown. However, if the number of cases of nvCJD in the U.K. remains low for the next several years, then scientists estimate that the overall risk of nvCJD to people exposed to BSE will be small. No cases of BSE or nvCJD have been identified in the U.S.
Also included in this deferral are donors who have received non-U.S. licensed bovine insulin or other injectable products made from cattle in BSE endemic countries, although there are no reports of nvCJD transmission by such products.
The U.K. includes England, Scotland, Wales, Northern Ireland, the Isle of Man and the Channel Islands.
Previous guidance recommended that potential donors with risk factors or a diagnosis of classical forms of CJD should be permanently deferred and that any blood products or plasma derivatives from these donors should be immediately retrieved, quarantined, and destroyed. However, under the revised guidance, withdrawal of plasma derivatives is no longer recommended in these cases. (The guidance remains the same for deferral of donors based on classical CJD and CJD risk and for quarantine of blood components not manufactured into plasma derivatives.) The reason is that laboratory and large epidemiologic studies suggest that the risk of classical CJD from plasma derivatives is extremely low. In addition, shortages of plasma derivatives due partly to the withdrawal policy related to CJD have caused serious disruptions in patient care.
Although there are no reports of transmission of classical forms of CJD from blood or blood products, nvCJD differs both in its symptoms and biology. In addition, less is known about nvCJD and whether it is transmissible through blood or blood products, although laboratory and epidemiologic studies are underway to evaluate this risk. Therefore, until more is known about the risk of nvCJD, withdrawal of all blood components and plasma derivatives made from donations from people later diagnosed with nvCJD is recommended.
The guidance can be obtained on FDA's Website at www.fda.gov/cber/guidelines.htm. Media questions on the Canadian guidance can be directed to Eric Morin, Health Canada at (613-957-2978).