FDA forms board to guide drug exclusivity rulings

The U.S. Food and Drug Administration Center for Drug Evaluation and Research has created a board to oversee and advise on exclusivity decisions, a move Reuters reports is intended to improve the clarity and consistency of those determinations.

The group will monitor the granting of five-year new chemical entity exclusivity, a status reserved for drugs containing an active ingredient that has not previously received FDA approval. The board will also supervise the issuance of three-year new clinical trial exclusivity, which applies to medications that utilize an already approved active ingredient but depend on new clinical studies conducted or financed by the manufacturer for their approval.

Belgian Prime Minister Bart De Wever has called for stronger protection of the nation's pharmaceutical sector, arguing that pressure from the U.S. and China threatens European industries despite their competitiveness, according to Anadolu Agency. Speaking on the sidelines of the European Union summit in Brussels on Thursday, De Wever linked the planned restructuring at GSK, which could lead to more than 1,200 job losses in Belgium, to the company's need to boost investments in the U.S.

De Wever also criticized China's practices in clinical trials, describing them as unfair competition supported by substantial state subsidies.