Originally published September 30 2005
FDA warns pharmaceutical firms about misleading drug ads
by Mike Adams, the Health Ranger, NaturalNews Editor
In the past year, the FDA has sent 17 warning letters to drug companies, compared to an average of four or five letters in previous years, about misleading drug advertisements.
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.
"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.
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.
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.
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