[Minutes, Advisory Committee to the Director GP-160 Meeting (1992: Bethesda, Maryland)]

187

1 soon.
2 So if you add logistical issue on
3 logistical issue, you even further delay the onset
4 time unless you can begin to address issues of supply
5 scale-up and so on.
6 And then the other one, which I hesitate
7 to lay on the table except that I have the scars from
8 it, is the issue of liability. While with digitalis
9 it's not a problem or even certain of the drugs that
10 is known where the source of liability lies, I would
11 advise that when Dr. Healy recommends to the Congress
12 that they recognize their responsibility in dealing
13 with the liability issue up front.
14 In the previous program that we dealt with
15 on this, the issue got raised at the eleventh hour and
16 created enormous problems. Now, since then there have
17 been attempts to have various programs -- Dr. Robbins
18 knows them well -- about how to deal with the
19 liability issue in vaccinology, but this is a little
20 different than a company-sponsored drug in one sense,
21 that who's carrying the liability burden for a trial
22 at this stage of the knowledge development and what
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