FDA Reform Bill Review: Need For Strong Leader

An unintended short-term effect of the US Food and Drug AdministrationModernization Act may be to slow down its nuts-and-bolts application review, says a Reed Smith Shaw & McClay review prepared for a House-Senate conference panel, co-authored by Marc Sheineson, ex-FDA Associate Commissioner for Legislative Affairs.

The bill's enactment is expected shortly before the November 14 Congressional recess. President Clinton still has misgivings, but is expected to sign it. Pushing enactment is the expired Prescription Drug User Fee Act legislation; a continuing resolution in both chambers kept this extended through October 26, and a second is now effective through November 7, allowing time to resolve the differences between the House and Senate versions.

In its zeal to provoke agency action, says Reed Smith, the bill requires dozens of new regulations, guidance documents, notices and reports to Congress, many within 180 days. Many FDA officials who review applications and mediate scientific and policy disputes will probably also prepare some of this material. The bill would require the FDA to act on eight issues within 180 days of its enactment and issue 13 regulatory documents within a year.