Playing hard ball

Genasense Lessons

Playing hard ball

Last week's meeting of FDA's Oncologic Drugs Advisory Committee to review Genta Inc's Genasense oblimersen received an unusual degree of political attention, expressed to the agency both publicly and privately. Two members of Congress asked ODAC to recommend approval of the drug, and at least one lawmaker telephoned the FDA Commissioner's office prior to the meeting to lobby for approval.

In addition to the political pressure, FDA and Nasdaq received requests from a former senior agency official to take actions intended to preserve GNTA's stock value.

Rep. Mike Ferguson (R-N.J.) called Acting FDA Commissioner Lester Crawford a few