Lengthy lists of drug side effects recited in TV ads are so baffling they may cause consumers to overlook the worst harms of the medicine, U.S. regulators said.
The Food and Drug Administration is studying whether disclosure limited only to serious side effects would improve consumer understanding, according to an agency document posted online today. To cover lesser side effects, the FDA proposed simply adding a line about “potential additional risks.”
Advertisements urging consumers to try pills for sleeping, erection problems, arthritis, high blood pressure and scores of other ailments are required to carry warnings of side effects in their television commercials in the interest of full disclosure. The long lists, delivered in voiceover that have been parodied in comic routines, confuse consumers and minimize the most dangerous risks, the agency said in its posting.
“Our hypothesis is that, relative to inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks,” the FDA said in its document.
The FDA plans to survey 1,500 study participants about ads with varying ranges of side-effect disclosure, then measure their understanding of risk.
The pharmaceutical industry spent $3.1 billion on direct-to-consumer advertising in 2012, according to the Pew Charitable Trusts.