US FDA sets up board to oversee drug exclusivity determinations

Oct 16 (Reuters) - The ‌US FDA's ​drug ​evaluation department said on Friday it has formed a board to oversee and advise on ‌exclusivity determinations made by the department, aiming ⁠to improve clarity and consistency of those decisions.

Here are more ‌details:

• FDA-granted exclusivity rewards innovation ‌by giving newly approved drugs a period of market protection, before lower-cost generic competitors enter the ​market

• The CDER (Center for Drug Evaluation and Research) exclusivity board will oversee certain exclusivity determinations, including ⁠whether and what type of exclusivity should be granted and the appropriate ​scope of grants, the agency said on Friday

• The board will focus on 5-year ​new chemical entity exclusivity that ‌is granted to a drug whose active ingredient has never before been approved by ⁠the FDA

• It will also oversee 3-year new clinical trial exclusivity grants that are meant for drugs that use ⁠a previously approved active ingredient, but their approval relies on ​new clinical studies conducted or funded by the sponsor

• It will advise on exclusivity for biological products too

• The board ‌will not review other types of exclusivity apart from the three, it said

• The ‌board also may evaluate and make recommendations regarding ⁠CDER's policies and practices ‌relating to exclusivity ​and maintain records of exclusivity determinations

(Reporting by Sneha S K in Bengaluru; Editing by Shinjini ‌Ganguli)

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