You may be right. Although we tend not to agree with it, in interest of full disclosure here's a news item from Bloomberg. Who knows how the political mill of the FDA will grind...
BUS 11:13 INVESTMENT LETTER COMMENTS ON FDA DECISION
Business Editors and Medical Writers
RYE, N.H.--(BW HealthWire)--May 9, 1997--In response to the heavy volume of inquiries regarding the implications of yesterday's FDA Advisory Committee rejection of Myotrophin for the treatment of ALS, NeuroInvestment released this comment by its publisher, Harry M. Tracy Ph.D.:
"We expect the Advisory Committee vote against Myotrophin to be overruled by the FDA, and Myotrophin approved, within the next two months. Post-marketing trials in conjunction with Rilutek should be and will be mandated. The FDA has already received congressional criticism about its handling of Myotrophin, and with the bit of sentiment in Congress for linking FDA to renewal of User Fees legislation, this could be a political and public relations nightmare for the FDA. The ALS patients who begged for approval in vain may have received a stony reception from the Advisory panel, but Congress will be less concerned with how 'robust' the statistics are, and more impacted by patients whose disease has long since robbed them of any chance of being 'robust' themselves. Since the FDA has permitted Cephalon to provide Myotrophin without charge, to now state that Cephalon cannot market it looks like a cross between biostastical nitpicking and economic gatekeeping, neither of which are the mission of an agency charged with protecting the public interest. With Congress appraising the Agency's performance and future, the FDA cannot afford at this juncture to appear to be choosing statistical purity over patient welfare. Over the next two months, the Dept. of HHS, the FDA administration and Congress are going to come to a meeting of the minds, and the FDA is not going to fall on its own sword to save an Advisory Committee decision that is small-minded and morally bankrupt. It will be overturned, and this process will have shown itself to be a costly and misguided abrogation of a level of clinical decision making that should be between doctor and patient."
CONTACT: NeuroInvestment
Dr. Harry M. Tracy, 603/964-9640 |
