PDUFA and the Increase in Drug Withdrawals

August 5, 2014 | A study published in Health Affairs has found that after the Prescription Drug User Fee Act was passed, the number of safety warnings and product withdrawals was higher than before. The Act, passed in 1992, represented an agreement between drug makers and the FDA under which drug makers paid fees to help fund the FDA, and the FDA agreed to accelerate drug approvals. The Health Affairs study looked at 748 new drugs approved between 1975 and 2009 to determine if the rate of warnings and withdrawals increased after the Act's passing. Pharmalot