FDA issues draft guidance to further reduce the possible risk of transmission of variant Creutzfeldt-Jakob Disease (vCJD) by blood and blood products

FDA issues draft guidance to further reduce the possible risk of transmission of variant Creutzfeldt-Jakob Disease (vCJD) by blood and blood products

August 28, 2001 M2 PRESSWIRE
FDA today issued draft revised guidance to the blood industry intended to further reduce the risk of transmission of variant Creutzfeldt-Jakob Disease (vCJD) to recipients of blood and blood products. Under the proposal, implementation of the policy would be phased in gradually in two stages next year to allow time to prepare for the changes and help maintain an adequate blood supply.

"FDA's goal is to strike a careful balance between increasing the safety of the blood supply while ensuring that life-saving blood and blood products remain available when needed," said FDA's Acting Principal Deputy Commissioner Bernard A. Schwetz, D.V.M., Ph.D. "We are taking these steps to help protect the safety of the blood supply at a time when science does not allow us to rule out the risk of transmission of vCJD through blood transfusions."

The recommendations proposed in this guidance are considered to be prudent until more definitive information about the natural history of vCJD is known, or donor-screening tests can be developed. Based on the best available science, the recommendations are designed to exclude donors who may have been exposed to the agent of BSE (bovine spongiform encephalopathy or "mad cow disease") in the United Kingdom (U.K.) and other parts of Europe. BSE has been linked to vCJD, a fatal degenerative brain disease found almost exclusively in the U.K. Currently, vCJD is not known to have been transmitted by blood transfusion. Furthermore, no cases of BSE or vCJD have been reported in the United States. However, animal models suggest that transmission by blood products may be possible. In addition, cases of vCJD in the United Kingdom continue to increase and BSE has become widespread in Europe.

The document is being issued as a draft for public comment within 30 days. Once comments have been evaluated, FDA intends to issue final guidance no later than the end of 2001.

The revised guidance, as proposed, includes changes that would expand the donor deferrals that have been recommended since August 1999 for donors who have lived or traveled in the U.K.

Also, it proposes exclusions for persons who were stationed at U.S. military bases in Europe from 1980 through 1996 because beef products from the U.K. were provided at these military bases during that period. FDA proposes that these changes be implemented by May 31, 2002.

In addition, FDA is proposing in the draft guidance that blood establishments should defer blood donors who have lived a cumulative period of five years or more in Europe from 1980 until the present. This does not include donors of Source Plasma (plasma intended solely for use in making further manufactured products) because plasma derivative products are highly processed, reducing risks of infectious diseases, and because of supply concerns. Although the risk of BSE exposure in the rest of Europe is much less than in the U.K., this uniform recommendation for Europe takes into account the difficulty in predicting how the BSE epidemic will evolve in Europe. It also allows for variations in food chain protection measures and their enforcement in different countries. FDA proposes that this change be implemented by October 31, 2002.

"Nationwide, under FDA's proposal, about 95 percent of those currently eligible to donate blood would remain eligible, yet the risk of possible exposure to vCJD would be reduced by approximately 90 percent," said Dr. Jay Epstein, Director of FDA's Office of Blood Research and Review. "We will continue to review these recommendations in the light of evolving scientific information about vCJD risks and the impact these policies may have on the blood supply."

FDA regularly seeks scientific advice at public meetings from experts with FDA's Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC). In June of this year, the TSEAC recommended that FDA revise its current guidance in accordance with the proposed recommendations described above.

The impact of these deferrals will differ in various locations depending on the amount of travel made by potential donors.

Deferrals are expected to be up to 50 percent greater than average in major urban areas along the East and West coasts.

Additionally, the New York metropolitan area, which currently depends upon blood imported from Europe for approximately one fifth of its supply, will be particularly affected.

The phased approach with two implementation dates is intended to allow more time for blood establishments to increase local recruitment efforts and, if needed, to establish alternate sources of supply. In order to accomplish this, it is important that blood centers avoid implementing the proposed deferrals more quickly than recommended.

Last week, the Department of Health and Human Services announced it is launching a new blood-monitoring system that will help the blood distribution network to operate more effectively. HHS Secretary Tommy G. Thompson has also announced plans to accelerate research and surveillance on BSE and related diseases.

Specific changes to the previous guidance that are being proposed include the following:

For implementation by May 31, 2002, deferral of donors who:

* Have spent three or more cumulative months in the U.K. from the beginning of 1980 through the end of 1996, when controls designed to keep BSE out of the human food chain were fully implemented in the U.K. (Previous guidance excluded donors who had spent six or more cumulative months in the U.K. in that same time period.); or

* Have spent five cumulative years or more in France from 1980 to the present; or

* As current or former U.S. military personnel, civilian military employees and their dependents, have lived for six months or more at U.S. military bases in Northern Europe Germany U.K., Belgium, and the Netherlands) from 1980 through 1990) or elsewhere in Europe (Greece, Turkey, Spain, Portugal, and Italy) from 1980 through 1996; or

* Have received a blood transfusion in the U.K. between 1980 and the present.

For implementation by October 31, 2002, deferral of donors who:

* Have spent a cumulative total period of five years or more in Europe from 1980 until the present.

The Department of Health and Human Services and FDA will work with others to promote increased blood donation by people who are eligible. New and former blood donors should contact their local hospital or blood bank to schedule a donation.

"It is essential that healthy people donate blood," said Dr. Schwetz. "It can be a gift of life."

The new draft revised guidance can be obtained on FDA's Website at http://www.fda.gov/cber/guidelines.htm.

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