(1:18 p.m.)

CHAIRMAN BROWN: Can the Committee please resume their positions at the front table? Again, will the Committee please be seated? We are going to commence the afternoon session.

And the first order of business on the afternoon session is to conduct an open public hearing, as we did yesterday. Dr. Freas has informed me that unlike yesterday, there are no advanced scheduled presentations from the audience or the public, but I, again, as yesterday, ask if there is anyone in the audience not on the Committee that at this point wishes to make any statement whatsoever. This is the time to do it.

(No response.)

CHAIRMAN BROWN: Seeing none, we will proceed directly to the Committee charge and presentation of questions presented by Dr. Hellman, Center for Diseases and Radiological Health in the FDA.

And it would behoove the Committee to pay attention closely to these questions which are slightly different than what you have in front of you.

Dr. Hellman.

DR. HELLMAN: Thank you very much, Dr. Brown.

And it's Center for Devices.

CHAIRMAN BROWN: Oh, what did I say?

DR. HELLMAN: Diseases. We're concerned about diseases as well as devices, but it -- no problem. It's what you had for lunch.


DR. HELLMAN: Thank you very much, Dr. Brown and members of the Committee, ladies and gentlemen.

I'd first like to thank all of the speakers this morning for uniformly excellent presentations. I did not know much about scrapie in sheep when I walked into the room. I don't know an awful lot now, but I know quite a bit. Thank you for that.

This morning Dr. Asher described the risk to humans from TSEs of animal origin. The concerns of transmitting TSEs through regulated products and the regulations -- the next overhead. Thank you -- and the regulations, policies, and practices that are in place to protect humans from exposure to animal TSEs.

Much of the concern of the regulatory agencies, as we've all heard, has focused on protection from the TSE agent of cows, that is, BSE because of the putative etiological relationship between BSE and new variant CJD in humans.

While the risk to humans from scrapie, a TSE of sheep, and goats pastured with infected sheep is theoretical, there are certain uncertainties regarding this theoretical risk that raise concerns regarding the use of sheep and goat derived material in regulated products.

Dr. Asher indicated that such materials are used in FDA regulated implantable and injectable products either as components of the final product or as manufacturing process reagents. The FDA recognizes the importance of evolving regulatory approaches as we gain new scientific and clinical information in order to assure the safety of the products that we regulate, and that's why we've brought this issue before you today.

Since the FDA has not articulated specific criteria for assurance that sheep and goat derived materials are free of the scrapie and BSE agents when derived from animals originating from or residing in countries where one or both diseases still occur, we convened the Committee in this open public forum to aid us in its evaluation of the use of goat and sheep derived materials in implantable and injectable medical products relative to the risk of TSE transmission.

This afternoon then I would like to present the charges -- there are two -- and the questions, of which there are two, developed by the FDA planning group to the TSE Advisory Committee.

I want to stress that the Committee is a very important resource and a vehicle for discussing the latest scientific information on TSEs and the potential risk of TSE transmission for the products that we regulate.

The Committee's first charge is to consider whether the current policies of the FDA's which rely on import restrictions and other policies of the USDA's are adequate to protect humans and animals from potential exposure to the BSE agent in FDA regulated products containing or produced with materials derived from sheep and goats originating in BSE countries or if additional precautions are needed.

The Committee's second charge is to consider appropriate precautions, including sourcing and selection of animals, veterinary scrutiny, monitoring of animals, feeding practices, and other measures that might be adequate to assure the FDA that materials obtained from sheep and goats from the U.S. or from other countries where scrapie occurs are free of the scrapie agent and can be used safely in FDA regulated products intended for injection or implantation.

In considering their charges, there are two questions that we would like the Committee to address, and we ask that the members of the Committee be polled on these questions.

Question 1: After considering the possible risk and benefits the TSE Advisory Committee is asked to advise the FDA whether any changes in current practices are needed, and this is a change in the language as it is in the overhead to make it a bit clearer for the Committee, and I reiterate, whether any changes in current practices are needed to insure that sheep and goats originating from or residing in countries where BSE occurs would provide acceptable sources of materials for manufacture of FDA regulated products intended for injection or implantation both as components of the products and as manufacturing process reagents.

Note that sourcing some materials from BSE countries would constitute a relaxation in precautions recommended by the FDA and might be prohibited by regulations of the USDA.

Question 2: After considering possible risks and benefits, the TSE Advisory Committee is asked whether any safeguards are needed, and this is a change in the language for clarity; again, whether any safeguards are needed to ensure that sheep and goats originating from or residing in countries where scrapie occurs are scrapie free and acceptable sources of materials for manufacture of FDA regulated products intended for injection or implantation both as components of the products and as manufacturing process reagents.

If so, what safeguards would you recommend? And this is for discussion only. The Committee will not be polled. Well, we've asked the Committee not to be polled on the different recommendations that they might consider. This is just for discussion purposes only.

To aid in your deliberations and discussions this afternoon, the Committee might consider certain points that were discussed in the topics covered this morning by our invited speakers. In addressing Question 1, you heard about the potential risk of introducing the BSE agent into sheep and goats in Europe from Professor Almond. Bear in mind that sheep most likely were fed contaminated meat and bone meal in the U.K.

This information might be considered in determining whether and under what provisions or safeguards sheep and goats from BSE countries would be acceptable sources of materials for FDA implanted and injectable products for human use.

In addressing Question 2, you heard a great deal of information about scrapie, ranging from experimental tissue infectivity studies in sheep and goats and the potential for human and animal exposures to scrapie and other TSE agents in the U.S. from Dr. Sutton of the USDA, to FDA regulations for ruminant feed, our feed ban, from Dr. Honstead, and measures for consideration in assuring scrapie free sources of sheep and goat derived materials from countries with scrapie by Dr. Ferguson of the USDA.

Among others, measures that might be considered might include appropriate precautions regarding animal sourcing and selection, veterinary scrutiny and monitoring of animals, and feeding practices, and both Drs. Asher and Ferguson suggested certain specific measures.

They were quite similar, and I would draw your attention to the last slide that Dr. Ferguson showed, and that contains the elements of the Australia import scrapie freedom assurance program, and whether some of those considerations could be used to establish a scrapie free program in areas or countries, regions that currently have scrapie, and these are quarantine, sentinel animals, germ plasm collection, bioassay, that is, the mesenteric lymph nodes, placenta, and pooled uterine washings, and examination of the brain of all infected animals and sentinels.

In closing, I would like to mention that in addition to addressing the questions posed, the TSE Advisory Committee should feel free to offer any other recommendations or suggestions on this issue, and to encourage open discussion, we welcome public comments on this issue, as well.

Thank you.

CHAIRMAN BROWN: Thank you very much, Dr. Hellman.

To reemphasize what we are asked to do now is to provide the FDA with a yes or a no vote with respect to whether or not any changes in current policy are needed for Question 1 and for Question 2. These will be the only two votes the panel will be asked to do.

With respect to the kinds of changes that are recommended, if they are, that will be a matter for discussion only. Unlike yesterday, there will not be polls taken of each individual member about what they suggest and the effort to arrive at some sort of consensus about what they might be.

We're doing a yes and no vote on whether any changes are needed. All discussion after that will be just discussion.

And having been stonewalled yesterday from trying to conclude any business without discussion, I will now open these two -- well, Question 1 for discussion, and also, feel free, members of the Committee, to ask of any of the speakers today, if they're all still here, additional information about any points that were not answered.

Yes - Discussion