Last issue, Voice, Vol. 20, No. 4, we reported that an advisory panel to the U.S. Food and Drug Administration (FDA) had voted, 7 to 2, to recommend approval of the inhaled insulin formula Exubera, for use by either type 1 or type 2 diabetics. Exubera is a joint venture between Pfizer, the French firm Sanofi-Aventis, and the California biotechnology researchers Nektar Therapeutics.
FDA Advisory panel recommendations are “advisory, not legislative”—but the FDA usually follows them. This time, they didn’t.
The companies reported on October 29, 2005, that FDA reviewers had requested “chemistry data on the diabetes treatment.” They did not specify particulars.
This “extended review” will delay the formal announcement of approval or disapproval for at least three months. Before this announcement, approval was expected around November 1, 2005.
Inhaled insulin would be a completely new territory—and would, of course,
bring new
safety questions. No one questions that it works—but the issues of long-term
safety must be addressed. The FDA is correct in insisting its questions be answered
first.