FDA PROPOSES BARRING 'ME-TOO' DRUG APPROVALThe Food and Drug Administration proposed on Monday rulesthat would bar approval of "me-too" drugs with similarmolecular structures to an approved medication under theOrphan Drug Act.
Developers seeking approval of such a drug would need toshow that it was more effective, safer or offered more topatient care than the orphan drug.
FDA Commissioner David Kessler said the agency seeks toensure that exclusive marketing rights "do not discouragedevelopment of improved therapies."
ECOGEN SIGNS BIOPESTICIDE PACT IN ITALY
Ecogen Inc. of Langhorne, Pa., said it signed a $2.1 millionbiopesticide research and development agreement with Italy's3A S.r.l, a public-private partnership to encourage enterprise.
Ecogen (NASDAQ:EECN) "will have unrestricted access toperform insect rearing, bio-assay and greenhouse trials" in 3A'sfacility in Umbria, Italy, said John Davies, Ecogen's chairman.The agreement also establishes a new company, Ecogen Europe,that will retain all rights to any new products developed.
END TO AIDS IMMIGRATION BAN URGED
The U.S. Department of Health Services last week recommendedlifting a controversial requirement that bars U.S. entry toforeigners with AIDS or any of six other communicablediseases. The public has 30 days to comment before furtheraction is taken.
(c) 1997 American Health Consultants. All rights reserved.