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FDA cracks down on misleading drug ads

U.S. Food and Drug Administration warnings to drug companies over misleading advertisements have more than tripled in the last year, an agency official said.
/ Source: Reuters

U.S. Food and Drug Administration warnings to drug companies over misleading advertisements have more than tripled in the last year, an agency official said.

The agency sent 17 warning letters in the 12 months ending in August compared with an average of about four to five letters in recent years, Thomas Abrams, head of FDA’s Division of Drug Marketing and Communications, told food and drug regulatory lawyers at a conference in Washington.

While the increase shows that agency staffers are better able to monitor materials, Abrams said, it also signals that companies are not doing enough to present balanced information.

Public Citizen Health Research Group’s Peter Lurie said the increase in warnings was unimpressive since enforcement actions has dropped significantly since 1998, when the agency issued 157 total letters, including both warning and related letters.

“Enforcement levels have dropped so low that boosting them has become very easy,” said Lurie, deputy director of the consumer advocacy group.

Alan Goldhammer, head of regulatory affairs for the Pharmaceutical Research and Manufacturers of America, said drug makers were trying to comply with FDA requirements. Voluntary guidelines issued by the industry group earlier this year aimed to improve ads, he added.

“I think companies try to do the best job they can when the design their promotional campaigns,” he said.

Lacking risk information
The majority of the 17 FDA letters cited companies for not including information about side effects and other risks in promotional materials for patients or doctors, Abrams said.

Many offending ads either left out certain serious risks, while others used very small font size to mention them at the bottom of the page.

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

About half the letters also warned companies for making false claims about how well the drug worked, while about 40 percent cited them for wrongly comparing the featured drug to a competitor, he added.

Abrams said drug makers should do more to more to comply with advertising rules, and should present possible problems just as clearly as the drug’s benefits.

“We are continuing to take necessary actions to ensure that prescription drug promotions have risk information,” he said, adding that companies should voluntarily comply.

Several guidelines about how to format promotions should be issued by the end of the year, he added.

For biological drugs, warning letters involving makers of vaccines, blood products and other similar therapies also rose, said Glenn Byrd, head of FDA’s advertising for biological drug quality office.

His staff sent eight warning letters about promotions in the last 12 months to various biological drug makers, he said.

From August 2003 to August 2004, the biological drugs division sent five such warning letters, according to the FDA Web site.

Byrd said the agency was developing a Web site for consumers to follow advertising issues that should be online in 2006.

An FDA representative for devices, Deborah Wolf, said she did not know how many warnings the agency sent to manufacturers in the last year because the device division does not have specific staff who review ads.