1. 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 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.