To: NCKEV who wrote (586 ) 3/8/1998 4:32:00 PM From: NeuroInvestment Read Replies (1) | Respond to
After two weeks blissfully out of touch with anything vaguely pertaining to the neuropharmaceutical industry, I found more email inquiries awaiting me regarding this issue than any other. I did not expect an Advisory Committee meeting, but there is a most probable explanation for its inclusion. New data is being presented, from the body of people taking Myotrophin under the T-IND. I do not think that the referral to the AC reflects a judgement about that data, it instead reflects internal politics. While I have been a harsh critic of this panel's acumen and priorities, they are people who fly in every few months for relatively little reimbursement. The FDA needs these institional 'extensions' partly because it is a cheap way to access expertise (though in the case of ALS/Myotrophin, it also shows that expertise is not everything it is cracked up to be). Having been on the firing line for two meetings focused on perhaps the most controversial issue to confront the FDA (how many drugs have senators circulating a petition?) in recent memory, this AC may have demanded that it be included in the review of the T-IND data. To not be included is to be pinch-hit for in the bottom of the ninth so to speak, and if they were to be treated as superfluous, some of them might justifiably wonder why they should play at all. Thus to assure this AC (and all AC's) that they matter, the FDA is going to have them participate. If the AC says no again, the FDA will regret this, because it will be caught between its surrogates and its Congressional masters....truly between a rock and a hard place.
