Timothy Cote, who was appointed Director of the Office of Orphan Products
Development in September, told "The Pink Sheet" that one of his top priorities in the coming year will be to persuade policymakers in Washington to increase the funding for grants for clinical development for orphan drugs.
To further encourage orphan drug availability, accompanying market-oriented incentives for orphan drug development were issued by the Office of Orphan Products
Development, under the auspices of FDA (11).
They oppose the initiatives by Senators Kennedy and Hatch to amend the law, because companies might be deprived of the fruits of their large investments in orphan product
R & D.
The FDA awards the grants through the Orphan Products
Clinical Trials Grants Program to encourage clinical development of drugs, biologics, medical devices, or medical foods for use in rare diseases.
Orphan Drug designation is granted by the FDA's Office of Orphan Products
Development for drugs that are expected to provide significant therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S.
A panel of experts reviewed 16 applications for the grants, which were mandated by Congress in 2007 and will be administered by the FDA's Office of Orphan Products
The FDA has named Timothy Cote, M.D., M.P.H., as the new director of the Office of Orphan Products
Instead, BIO believes that orphan products
with fewer than 30,000 OPPS claims should be reimbursed at hospital invoice costs and that those with over 30,000 claims should also be reimbursed at invoice if the prescriptions are made to treat the orphan indication.
And at the end of the chain of evaluation that applies to all new medicines in the EU, four orphan products
have already received their marketing authorisation, and a fifth is expected shortly.
The ODA provided 7 years of market exclusivity and expanded tax credits for companies developing and marketing orphan drugs, established an Office of Orphan Product
Development at the Food and Drug Administration (FDA), and created the Orphan Products
are developed to treat rare diseases, or conditions that affect fewer than 200,000 people in the US.
In the United States currently, 194 drugs and biologics have been brought to market as orphan products
, but none are vaccines.