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Medical Forum / General / Alternative / September 2005US FDA steps up action on misleading drug ads
http://news.yahoo.com/s/nm/20050919/hl_nm/advertising_dc 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. Where's Mr. Pepper? Get that Accutane suicide registry up! If dermatologists and PCPs et al Would be MORE responsible about monitoring patients and perform Suicide Risk Screening Accutane likely could be used safely. But dermatologists do not act responsibly. I know this for fact, as I wrote part of the earlier pregnancy prevention programs and an embryology teaching module for derms and PCPs. I saw the data ~ Derms prescibe and monitor irresponsibly. Dermatologists DO NEED TO MONITOR for suicide risk and record accurately in patient records. If you don't, you are practicing medicine irresponsibly, and you may lose a young life, your patient ~ ! GET with THE PROGRAM suckers http://www.ahrp.org/infomail/04/12/07.php I took that stuff. It depressed me, too. But it works! > http://news.yahoo.com/s/nm/20050919/hl_nm/advertising_dc > [quoted text clipped - 32 lines] > drug promotions have risk information," he said, adding that companies > should voluntarily comply with standards. They sure are getting tough. They are actually writing letters. 17 of them. Wow. Now that is action. TC 17 to whom from whom? > 17 to whom > from whom? "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." If you are unable to read the post, why the f are you responding to it? TC |
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