Dr. Dorothy Scott, Medical Reviewer, OBRR, FDA, presented a summary of the previous committee discussion on donor deferral issues from the June 28 & 29 TSEAC meeting. She then gave an overview of FDA’s draft guidance, focusing upon the new donor deferrals for risk of vCJD, as recommended by the TSEAC on June 28, 2001. Dr. Scott briefly reviewed the rationale for not deferring donors who lived in the U.K. since 1996, which is based upon effective measures to prevent entry of BSE into the human food chain. She mentioned the recent finding of BSE in Japan, which is under discussion at FDA. In addition, she reviewed the rationale for deferring blood, but not Source plasma donors who have lived in Europe, for vCJD exposure risk. This draft recommendation is based upon scientific studies, which suggest that plasma derivative manufacturing removes TSE agents, and upon concerns about the impact of such a deferral upon availability of products such as IGIV and Factor VIII. Finally, she reviewed efforts which are being made, within the guidance, and without, to attenuate the impact of new deferrals on the blood supply. A more comprehensive review of this issue by the TSEAC is anticipated in the near future. The draft guidance will be open for public comment until October 28, 2001.

Next the Committee received a report from Dr. Stephen Nightingale, (Executive Secretary DHHS Advisory Committee on Blood Safety and Availability) on DHHS ‘s recent monitoring program for blood supply and current plans to extend this monitoring program to the supply of plasma derivatives and their recombinant analogs. He then gave a summary of the DHHS meeting held on September 24, 2001 to discuss the Department’s BSE/TSE Action plan (draft summary on web site). The committee then heard presentations from America’s Blood Centers, American Red Cross, New York Blood Center and the Department of Defense. As a result of the open public hearing and these presentations the committee received suggestions for improving the DHHS monitoring program, and suggestions for FDA’s consideration on their Draft Guidance. The committee chair stated that it would be nice to have a uniform set of blood donor deferral criteria, but that two sets of criteria can exist and that the two sets of criteria may eventually evolve and the differences may be reduced.

The committee heard presentations from major amino acid manufacturers on their current and previous sourcing of amino acids and their production processes.

The committee’s discussion focused on reducing risk of TSE transmission as a result of the use of amino acids as reagents or excipients in other CBER regulated compounds. They discussed the possibility of requiring manufacturers to validate their process if they choose to use bovine derived material (with the exception of milk and hair). They suggested that although the risk of TSE transmission was low, that manufactures should avoid using bovine material and if used, it should be sourced from a BSE-free country. However, they acknowledged that the designation of BSE free countries was difficult and constantly changing and in most cases the manufacturers had already switched from bovine to vegetable sources. They emphasized that due to the amino acid production processes which included hydrolysis, purification, chromatography and filtration that the risk of TSE transmission was very small.

It should be noted that the committee stated that the potential risk posed by amino acids for production of products already on the market is so minimal that no effort need be made in constraining use or availability of these products.

The committee then voted on the following three questions.

1. Does the committee think that the current manufacturing process and control methods utilized by the manufacturers of amino acids can minimize the risk to allow bovine-derived amino acids from BSE countries to be used as reagents and excipients for the production of pharmaceutical products?

The committee voted: 1 yes vote, 18 no votes, and 0 abstentions.

The committee then voted on a recommendation formulated by the chair:

That the committee should recommend to FDA not to allow ruminant source material (with the exception of material such as milk as milk gelatin and and hair) to be used from BSE countries.

The committee voted: 18 yes votes, 1 no vote (one member changed his vote to this "no" vote after the initial count, but before the meeting adjourned) and 0 abstentions.

 

2. The committee modified this question to - Does the committee think that in all circumstances the risk:benefit ratio would still be in favor of a subject receiving any product where suspect amino acids had been used during manufacture of that product?

The committee voted: 19 yes votes, 0 no votes, and 1 abstention.

3. If not, does the committee think that the current manufacturing process and control methods utilized by the manufacturers of amino acids can minimize the risk to allow other ruminant-derived amino acids from BSE countries to be used as reagents and excipients for the production of pharmaceutical products?

Based on the other answers this question is now a "moot point".

4. Question 4 in the briefing packet was not discussed.