The study demonstrates a decades-long pattern of flexibility in the FDA's review of
orphan drugs.
In 1985, inspired by the fact that, within two years of passage of the
Orphan Drug Act, 54
orphan drugs were under development or already approved, Congress decided to extend the Act's authorization of research grants and expand its protection of marketing rights to all
orphan drugs rather than just unpatentable ones.
WASHINGTON -- Incentives incorporated in the
Orphan Drug Act have helped with the clearance of over 250 such medications over the last two decades, according to the Food and Drug Administration.
Of the 64
orphan drugs approved for use, five lost their exclusivity this year: Chenix, made by Solvay Pharmaceuticals of Marietta, Ga.; Opticrom, by Fisons Corp., Rochester, N.Y.; Trexan, Du Pont Merck Pharmaceuticals, Wilmington, Del.; Pentam, Fujisawa Pharmaceutical Corp., Deerfield, Ill.; and Panhematin, Abbott Laboratories, Abbott Park, Ill.
Orphan Drug Survey 1992 1991(*) 1989 SUMMARY OF SURVEY RESULTS Active designations 488 422 299 Approved medicines 64 54 36
Orphan drugs development 189 176 133 Companies developing
orphan drugs 132 120 85 SURVEY RESULTS BY DEVELOPMENT STATUS Phase I 17 20 15 Phase I/II 10 4 6 Phase II 61 49 39 Phase II/III 6 14 8 Phase III 97 86 61 Phase III completed 1 0 0 Phase III/application submitted 1 0 1 Applications submitted 46 50 39 Applications pending 0 0 1 Clinical trial status unidentified 3 9 2 RESEARCH PROJECTS(**) 242 232 172 RESULTS BY DISEASE CATEGORY AIDS and related conditions 20 24 18 Cancer 58 54 37 Childhood diseases 50 46 38 Diseases of women 17 12 9 Genetic disorders 35 31 28 Neuromuscular disorders 15 11 10 (*)There was no comparable survey in 1990.
The law drew complaints that, in rare cases, it was letting
orphan drug manufacturers profit without challenge.
According to a report recently released by the Pharmaceutical Manufacturers Association, in cooperation with the Food and Drug Administration's Office of Orphan Products Development and the National Organization for Rare Disorders, 133
orphan drugs that combat 96 rare diseases are currently being developed.
Orphan drugs form a niche yet considerably profitable segment of the pharmaceutical industry.
Whereas
orphan drugs get 10 years of exclusivity in Europe, plus extra time for pediatric indications.
[ClickPress, Tue Mar 12 2019] Market Research Reports Search Engine (MRRSE) has recently updated its massive report catalogue by adding a fresh study titled "
Orphan Drugs Market Projections & Future Opportunities Recorded for the Period until 2025".
The
Orphan Drug Report 2017 also found that only three in ten OD developers are still classified as biotech SMEs.
London, United Kingdom, June 27, 2016 --(PR.com)-- SMi Group's 5th annual conference on
Orphan Drugs and Rare Diseases returns to London this Autumn and will explore how payers, pharmaceutical, biotech and patient organisations are preparing to participate in and leverage the growing
orphan drugs and rare diseases industry.