U S Government Accountability Office

Electronic drug labeling U S Government Accountability Office

" Public health experts note the importance of providing physicians, pharmacists, and consumers with the most current prescription drug information to help inform their respective decisions on which drugs to prescribe, how best to counsel patients, and how to use drugs safely. FDA reviews manufacturer-developed drug labeling, which is generally available in paper form. However, prescription drug labeling is also publicly available in electronic form on government-operated websites. Drug manufacturers have supported eliminating paper labeling, thus relying on electronic drug labeling as a complete substitute for paper labeling. However, others, such as drug labeling manufacturers and patient advocates, disagree, suggesting that it could adversely affect public health. GAO was mandated to examine the benefits and efficiencies of electronic labeling as a partial or complete substitute and its impact on public health. Because drug labeling is already available in electronic form, representing a partial substitute, this report focuses on (1) the advantages and disadvantages of relying on electronic labeling as a complete substitute for paper labeling and (2) the barriers associated with relying on electronic labeling as a complete substitute for paper labeling. GAO interviewed federal officials, including those from FDA, and stakeholders representing physicians, pharmacies, patients, drug manufacturers, and drug labeling"