FDA user fee revenue exceeds $7 billion, analysis shows

FDA has collected $7.67 billion in user fees since pharmaceutical manufacturers began paying the fees in 1992, according to a new analysis by Avalere Health. The fees were instituted to accelerate FDA drug approvals and have increased every year since 1992.

FDA has collected $7.67 billion in user fees since pharmaceutical manufacturers began paying the fees in 1992, according to a new analysis by Avalere Health. The fees were instituted to accelerate FDA drug approvals and have increased every year since 1992. However, FDA expects to cut its collections for fiscal year 2017, having "significant leftover collections from the previous 4 years," the analysis states. "The significant unspent funds leftover from user fee programs suggest that FDA could do more to accelerate product reviews," says Jay Jackson, manager at Avalere. Amid intensifying public focus on prescription drug prices, some lawmakers say the FDA drug approval process needs to be faster in order to boost competition and lower costs.