DDMAC head says warnings on ads have more than tripled in last year

Share this article:
FDA warnings on misleading ads have more than tripled in the last year, Tom Abrams, head of the FDA's Division of Drug Marketing and Communications, said yesterday.
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." 
Several guidelines about how to format promotions should be issued by the end of 2005, Abrams added.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Judge blocks FDA bid to allow generic Precedex

Judge blocks FDA bid to allow generic Precedex

The US District Court for Maryland granted Hospira a temporary restraining order (TRO) against FDA, after the agency determined that potential generic competitors of the company's injectable sedation drug Precedex ...

GSK drug gets aplastic anemia indication

GSK drug gets aplastic anemia indication

Promacta was previously indicated for chronic immune thrombocytopenia.

Five things for Pharma Marketers to know: Wednesday, August 27

Five things for Pharma Marketers to know: Wednesday, ...

Allergan sets a shareholder voting date, Novo describes the types of acquisitions it will consider, and the AstraZeneca-Pfizer talks can now reopen.