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Oct 14, 2002
 |  BioCentury  |  Politics, Policy & Law

Long-winded questions; short replies

Mark McClellan, the Bush administration's nominee to head the FDA, provided few real clues to what future agency policy might look like under his regime in written congressional testimony last week, although he did reveal some ambivalence about establishing a process for approving biologic generics and firm opposition to reimportation of pharmaceuticals from Canada.

McClellan provided terse responses to written questions posed by members of the Senate Health, Education, Labor and Pensions Committee. The answers - in most cases shorter than the lawmakers' queries - were calibrated to avoid political controversy and revealed little about McClellan's personal views.

HELP committee Chair Edward Kennedy (D-Mass.) has forwarded the McClellan nomination to the full Senate, but a final confirmation vote has been delayed by objections to administration policies that are not related to the FDA or McClellan (see BioCentury Extra, Friday Oct. 11).

In his questions, Kennedy noted that there is no legal mechanism for approving abbreviated biologics license applications. According to the lawmaker, it can be argued "that this is appropriate because biotechnology products differ...

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