Reporting requirements, clinical trials and an inside look behind the process from a pharmacist
Headache. Dry mouth. Liver damage. Exhaustive lists of side effects are ubiquitous with every television advertisement for prescription drugs.
A mix of business, regulations and scientific trials are the reason why these laundry lists of side effects appear in only two countries - the United States and New Zealand. Here in the U.S., while advertising for drugs has an extended past, broadcast television, direct-to-consumer advertisements didn't begin until the Food and Drug Administration (FDA) relaxed guidelines in 1997.
"I'm not a fan of advertising drugs because I think it creates more confusion," said Joseph Saseen, PharmD, associate dean for clinical affairs and professor at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences. "It is really difficult for the average American to understand what is being put in front of them when there is complex medical information about medications," Saseen said.
"We almost have to beg the question, why should we even have drugs in commercials since most patients don't self-diagnose major illnesses, these advertisements are for such conditions that must be diagnosed by appropriately credentialed clinicians," Saseen said.
In the following Q&A, Saseen explains how the process behind drug approvals and the current FDA requirements for side effect disclosures, creates a uniquely American cultural artifact.
