Aaron S Kesselheim1, Joshua J Gagne1, Jessica M Franklin1, Wesley Eddings1, Lisa A Fulchino1, Eric G Campbell1. 1. Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital (ASK, JMF, WE, LAF, JJG) and the Mongan Institute for Health Policy, Massachusetts General Hospital (EGC), Harvard Medical School in Boston, MA, USA.
Abstract
PURPOSE: Skepticism about the safety and effectiveness of certain generic drugs remains, particularly related to generic drugs that are approved by the Food and Drug Administration (FDA) using product-specific bioequivalence studies that differ from the standard testing pathway. The current study was designed to assess patient knowledge and perceptions of the generic drug approval process. METHODS: We conducted a survey of patients with 10 different chronic diseases. We recruited survey participants from the CVS Advisor Panel, a proprietary database of 124 621 CVS customers pre-consented to participate in online research activities. We created a survey to collect data on patients' perceptions of the FDA's generic drug approval process, as well as their experiences with generic drugs approved using modified bioequivalence approaches used to treat their chronic medical conditions. RESULTS: Our survey of 753 patients with chronic diseases (65% response rate) showed that most (74%) expressed little familiarity with FDA's approval process for generic drugs, but nearly all (89%) believed that FDA approval ensures the safety and effectiveness of generic drugs. About one-fifth of respondents reported hearing concerns about their generic drugs, most commonly from physicians (35-36%) and the Internet (32-38%), but there were no differences in patients' reports of concerns about generic versions of the six study drugs approved using product-specific pathways versus comparator drugs. CONCLUSIONS: Patients have little knowledge about the generic drug approval system, but positive belief in the safety and effectiveness of generic drugs. Patients do not appear to have greater concern about generic drugs approved via product-specific pathways.
PURPOSE: Skepticism about the safety and effectiveness of certain generic drugs remains, particularly related to generic drugs that are approved by the Food and Drug Administration (FDA) using product-specific bioequivalence studies that differ from the standard testing pathway. The current study was designed to assess patient knowledge and perceptions of the generic drug approval process. METHODS: We conducted a survey of patients with 10 different chronic diseases. We recruited survey participants from the CVS Advisor Panel, a proprietary database of 124 621 CVS customers pre-consented to participate in online research activities. We created a survey to collect data on patients' perceptions of the FDA's generic drug approval process, as well as their experiences with generic drugs approved using modified bioequivalence approaches used to treat their chronic medical conditions. RESULTS: Our survey of 753 patients with chronic diseases (65% response rate) showed that most (74%) expressed little familiarity with FDA's approval process for generic drugs, but nearly all (89%) believed that FDA approval ensures the safety and effectiveness of generic drugs. About one-fifth of respondents reported hearing concerns about their generic drugs, most commonly from physicians (35-36%) and the Internet (32-38%), but there were no differences in patients' reports of concerns about generic versions of the six study drugs approved using product-specific pathways versus comparator drugs. CONCLUSIONS:Patients have little knowledge about the generic drug approval system, but positive belief in the safety and effectiveness of generic drugs. Patients do not appear to have greater concern about generic drugs approved via product-specific pathways.