On Sept. 20, the FDA put off reviews of two Fabry disease drugs developed by Genzyme Corp. and Transkaryotic Therapies Inc., both in Cambridge. Last week, investors pounded Transkaryotic shares on fears that its Europe-approved Fabry drug, Replagel, might not win the FDA's nod.
At an industry investment conference last week, the effect of a leaderless FDA was apparent to Craig C. Taylor, a 20-year veteran biotech investor with Alloy Ventures in Palo Alto, Calif. "I spoke with one public fund investor who said that they are not committing any funds that are subject to the capriciousness of the FDA," Taylor said on Friday.
Even if an FDA chief is sworn in by week's end, that may not change the agency's go-slow approach, warns Dr. Henry I. Miller, a one-time FDA official whose agency group approved the first biotech medicine to reach the market 20 years ago. With few political appointees and a lot of autonomy among agency groups, Miller said, FDA staffers can easily resist reformers.