02/04/2010 Fresh on the heels of last year's
record setting pace for citing drug manufacturer advertising and promotion violations, FDA's
drug advertising division is at it again 2/3 with the release of four new "notice of violation" letters
to industry.
Last year, FDA's Division of Drug Marketing, Advertising and Communications almost doubled
(from 21 to 41) the number of warnings sent to marketers presumably in response to promises of increased enforcement
actions by agency commissioner Margaret Hamburg.
Already one month
into the new year, the agency has posted 11 such letters citing drug marketers on their envelope-pushing advertising
and promotion practices.
Today's letters include:
- A Novalar Pharmaceuticals patient brochure for OraVerse (phentolamine) injection that
omits and minimizes risk information, broadens the drug’s indication, and overstates its efficacy;
- A Sanofi-Aventis patient brochure for BenzaClin
(clindamycin 1%-benzoyl peroxide 5%) gel that is false and misleading because it overstates the product’s
efficacy, omits material facts and important risk information, and makes a false or misleading claim about it;
- A waiting room sign for Meda Pharmaceuticals’
Astelin (azelastine HCl) nasal spray thatomits and minimizes important risk information, broadens the indication,
and overstates the drug’s efficacy; and
- A Web page for Lilly’s Adcirca (tadalafil) tablets that omits risks and two patient
videos that overstate the drug’s efficacy
Coverage on these letters and more can be view
at FDA Webview (www.fdaweb.com) -- the Internet's leading online daily FDA regulatory and compliance news site.
See related reports below:
 Several Violations Seen in OraVerse Brochure [318 Words] | | CDER’s Division of Drug Marketing,
Advertising, and Communications says that a Novalar patient brochure for OraVerse minimizes its risks and broadens
its indication. | | 02/03/2010 |
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| Astelin Waiting Room Sign Seen as Misleading [338 Words] | | CDER’s Division of Drug Marketing,
Advertising, and Communications says that a waiting room sign for Meda’s Astelin overstates its efficacy
and minimizes its risks. | | 02/03/2010 |
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| | | Problems Found in Adcirca Web Page, Videos [275 Words] | | CDER’s Division of Drug Marketing,
Advertising, and Communications says that a Web site and two patient videos for Adcirca omit risk information
or overstate efficacy. | | 02/03/2010 |
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| | | TV Ads Becoming More ‘Subtle’ [353 Words] | | Bloomberg News says there are mixed opinions
about the effectiveness of the trend in drug DTC ads to become more subtle and serious. | |
01/27/2010 | | | |
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