Most Common Offense is De-emphasizing Serious Side Effect Risks in Advertisements

On September 19, 2005 Thomas Abrams, head of FDA’s Division of Drug Marketing and Communications, told food and drug regulatory lawyers attending a conference in Washington, D.C. that the number of warning letters sent to drug companies about misleading direct-to-consumer ("DTC") advertisements and other promotional materials have more than tripled in the last year. 

Abrams said that in the 12-month period ending in August 2005 the FDA had sent 17 warning letters about misleading ads and promotions. In comparison, the FDA had sent an average of only four to five such warning letters in recent years.

According to Abrams, more than 75% of these FDA warning letters cited the drug companies for not including sufficient information about serious side-effect risks in their DTC ads and other promotional materials directed at patients or doctors.

In particular, many of the offending DTC ads left out certain serious side effects, while some others used only very small print at the bottom of an advertisement when it came to possible side effects associated with the respective drug.

"Industry can make efforts to better present risk information," Abrams said. "This is critical to public health."

Abrams said the drug companies should do more to voluntarily comply with the FDA’s advertising rules and standards.  Most importantly, he urged, the drug companies should strive to present possible side effects just as clearly as they assert their drug’s benefits.

"We are continuing to take necessary actions to ensure that prescription drug promotions have risk information," Abrams said.

Concluding, Abrams told the conference audience that several FDA guidelines concerning how the drug companies format their promotional materials, including DTC ads aimed at patients, should be issued by the end of 2005.  In part, the FDA is considering how it might revise rules about the extent of side-effect risk information which should be included in DTC ads, and whether all consumer-directed advertisements must be reviewed by the FDA before broadcast or publication.

(Posted by: Tom Lamb)