- Written by GlobalData's infectious disease analyst, Dr Brad Tebbets.
While the world focused on the fate of the Affordable Care Act, another important piece of healthcare legislation worked its way through Congress, the Prescription Drug User Fee Act (PDUFA) V. First introduced in 1992, PDUFA authorizes the FDA to collect fees from companies seeking approval of new drugs. The FDA uses these funds to hasten the drug review process. PDUFA must be approved every five years, and the fifth iteration has to be renewed by this October. PDUFA V has been approved by both houses of Congress and awaits President Obama’s signature. As with most pieces of legislation, PDUFA V is multifaceted, but the Generating Antibiotic Incentives Now (GAIN) Act alone could dramatically influence the pharmaceutical industry.