DDMAC head says warnings tripled
The FDA sent 17 warning letters in the 12 months ending in August compared with an average of about four to five letters in recent years, said Abrams, who made the comments to food and drug regulatory lawyers during a conference in Washington, the Associated Press reported.
The majority of letters, about 82 percent, cited companies for not including information about side effects and other risks in promotional materials for patients and doctors, Abrams explained. About half the letters also warned companies for making false claims about drug efficacy, while about 40 percent cited them for wrongly comparing the featured drug to a competitor.
"Industry can make efforts to better present risk information," Abrams said.
"This is critical to public health . . . We are continuing to take necessary actions to ensure that prescription drug promotions have risk information," he added.
Several guidelines about how to format promotions should be issued by the end of 2005, Abrams said.