Monday, January 29, 1996
WASHINGTON - Despite dwindling prospects for major FDA reform
efforts by Congress, legislative and administrative maneuverings continue to
keep alive prospects for continued changes in the regulatory framework this
The potential exists to expand the agenda for administrative reform, as the agency and biotech industry leaders begin to discuss procedural changes that would directly benefit emerging companies engaged in early-stage product development.
The industry-agency discussions, planned for early next month, come as the light at the end of the legislative tunnel to reform dims with every passing day. Senate action on an FDA reform bill drafted by Sen. Nancy Kassebaum, R-Kan., (see BioCentury Nov. 6) has been stalled by the budget debate and a host of other issues; House legislation still hasn't been written.
Legislation must be adopted by both houses of Congress by June 15, at the latest, if it is to escape the partisan crossfire of the presidential campaign, according to Biotechnology Industry Organization President Carl Feldbaum.
Congressional staff last week said that rather than write a separate bill, the House