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Evaluating the Impact of Generic Drug User Fee Amendments (GDUFA) on Speed of Generic Drug Entry (306758)
Anirban Basu, University of Washington, The Comparative Health Outcomes, Policy, and Economics (CHOICE) InstituteGary Chan, University of Washington
*Shuxian Chen, University of Washington, The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute
Keywords: policy analysis, generic drug, survival analysis, recurrent event
Generic drugs can bring more competition to the market and help to control drug costs. Governmental pharmaceutical policies operate to balance innovation and access, and to encourage more generic entries to provide more competition. In 2012, a five-year program called the Generic Drug User Fee Amendments (GDUFA) was enacted. By charging new generic applicants a user fee, GDUFA aims to speed access to generic drugs and therefore bring a quicker drop in drug price. Estimating its efficiency in speeding access to generic drugs can suggest the necessity of future policies.
We identify the order of generic entry for each branded drug using drug approval and exclusivity information from the Approved Drug Products with Therapeutic Equivalence Evaluations database between 2007 and 2017. Since subsequent generic entries can be viewed as recurrent events, the Prentice, Williams and Peterson - Total Time (PWP-TT) model has been applied. Initial results from the survival analysis suggests that there’s insufficient evidence of decrease in time to entry due to GDUFA, especially for the first three entrants.
The renewal of GDUFA with additional economic burden may further discourage entry.