FDA steps up action on misleading drug ads
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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 on Monday.
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.
The majority of the 17 letters, about 82 percent, cited companies for not including information about side effects and other risks in promotional materials for patients or doctors.
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 drugmakers 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 with standards.
Several guidelines about how to format promotions should be issued by the end of the year, he added.
Glenn Byrd, head of advertising for FDA’s biological drug quality office, said letters involving makers of vaccines, blood products and other similar therapies also rose.
His office sent eight warning letters last year to various biological drug makers, including MedImmune Inc. and Ovation Pharmaceuticals, Inc, he said.
From August 2003 to August 2004, the biological drugs division sent five warning letters, according to the FDA Web site.
Byrd also 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.
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