AndroGel Package Label Changes The Effects of Direct-to-Consumer Advertising on Public Health Chris Cozzolino, Cambridge Hampsher, Diana Theusch Project Mentor: Dr. Kevin Moores University of Iowa College of Pharmacy Background Direct-to-consumer advertising (DTCA) for testosterone replacement therapy has been a growing concern for men because of the emphasis placed on “low T” and the lack of safety warnings presented in the advertisements. The FDA regulatory guidelines on DTCA allow advertisements to be shown to the public before long term clinical studies on the effect of the drug are conducted. This may lead to physician overprescribing and lead to potential irreversible, life-threatening adverse effects. Results Results AndroGel Package Label Changes Results 2009 Boxed warning for "secondary exposure to testosterone" 2014 "There have been post-marketing resports of venous thromoembolic events, including DVT, and PE, in patients using testosterone products such as AndroGel" "If a venous thromboembolic event is suspected, discontinue treatment with AndroGel and initiate proper workup and management" 2015 Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men Patients should be informed of this possible risk when deciding whether to use or to continue to use AndroGel Objectives Describe the impact of FDA regulation on DTCA prevalence Describe the impact of DTCA on product labeling changes Describe the impact of DTCA on prescribing patterns Data from: Finkle W., Greenland S. (2014) Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men. PLOS Data from: FiercePharma; Nielsen; 2014 Limitations Delay advertising for new products Ban product-specific ads Pre-clearance by the FDA Include quantitative information rather than qualitative Methods FDA regulations for advertisements Drug company advertisement expenditure AndroGel approval package AndroGel post-advertisement Black Box Warnings Guideline treatment for hypogonadism Prescribing patterns from Statista database Conclusion In conclusion, there is a strong correlation between direct-to-consumer advertisement, physician prescribing, and adverse events. Due to companies taking advantage of the current advertising rules, the FDA has recently enforced changes to increase drug companies advertisement standards that were put into place October of 2018. Future research studies need to be done to prove that DTCA is negative for public health. 2016 Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions Journal of the American Medical Association (2013). Trends in Androgen Prescribing in the United States, 2001 to 2011.