Grants To Stimulate Product Development for Rare Diseases

International Journal of ChemTech Research

article

M. P. Venkatesh¹  Sridhar S²  Kavya Sravanthi G²  T M Pramod Kumar³ 

[1] Pharmaceutical Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, Jagadguru Sri Shivarathreeshwara University;Pharmaceutical Regulatory Affairs, Department of Pharmaceutics, JSS College of Pharmacy, Jagadguru Sri Shivarathreeshwara University;Department of Pharmaceutics, JSS College of Pharmacy, Jagadguru Sri Shivarathreeshwara University

关键词: Orphan drug;    Grants;    Treatment;    Funding;   

DOI  :  10.20902/IJCTR.2018.110210

学科分类：农业科学（综合）

来源: Sphinx Knowledge House

【 摘 要 】

FDA is committed in advancing rare disease therapies through the development oforphan products. There are about 7000 rare diseases that collectively affect over 30 millionpeople worldwide. The Orphan Drug Act (ODA) of 1983 was signed into law, which is one ofthe most important parts of health care legislation today. In the past decade before ODA waspassed, only 10 treatments were available for rare diseases. The main objective of this study isto compare the situation of rare diseases before and after the developments of the products,and to know the clinical phases (I-IV) involved during the product development process slatedfor rare diseases. FDA receives funding’s from the National Institute of Health (NIH) for thedevelopment of products for rare diseases. The growth of pharma industries has slowed inrecent years for reasons such as patent expirations, generic competition and stringentregulatory guidelines. Orphan drugs may help pharma companies to reduce the impact ofrevenue loss caused by patent expires of blockbuster drugs. Although pharmaceutical industryfaces many challenges, orphan drugs seem to offer the key for recovery and stability withinthe market. Rare diseases need more attention due to lack of proper diagnosis and treatment.To treat these rare diseases, USFDA has awarded 18 new research grants totalling more than$19 million to boost development of products for treating rare diseases. The implications ofsuch findings for future development and marketing of therapies for rare diseases aredeveloped.

【 授权许可】

CC BY