FDA warns Bayer about YAZ ads
Pharma Compliance Alert, October 15, 2008
Two 60-second direct-to-consumer advertisements for Bayer’s birth control pill YAZ overstate the product’s effectiveness, according to an FDA warning letter.
The FDA said the ads also broaden the drug’s indication and minimize serious risks associated with the use of the drug.
Bayer’s “Not Gonna Take It” and “Balloons ads” do not use the full phrase “premenstrual dysphoric disorder” (PMDD) to differentiate between that condition and premenstrual syndrome (PMS). YAZ is not approved to treat PMS. In addition, the symptoms displayed in the ad are more common in women with PMS. The ads also claim YAZ is approved for acne of all severities even though it is not.
Comments
0 comments on “FDA warns Bayer about YAZ ads ”
Related Products
-
ePharm5 InDepth
EPharm5 e-mail newsletter delivers the top 5 developments in pharma business innovation, with original research, interviews...
-
Healthcare Marketing Advisor
Healthcare Marketing Advisor provides concise, time-saving strategies for branding, promoting, and advertising your...
-
Marketing Oncology: Strategies for Service Line Campaigns
During this 90-minute Webcast, expert healthcare marketers discuss the research and strategic planning that should be the...
-
The Complete Guide to Hospital Marketing, Second Edition
The Complete Guide to Hospital Marketing, Second Edition looks at the complex field of healthcare marketing in a...
-
Complete Guide to Lab Safety, 3rd Ed.
The third edition of this popular resource makes training and compliance easier by consolidating regulations from all...
Most Popular
- Articles
-
- HIPAA Q&A: Flu shot requirement for hospital employees
- Running an effective peer review committee meeting
- HealthDataInsights posts new issues for medical necessity claims
- Sneak Peek: Effort underway to establish caseload benchmarks
- New FAQ posted on storing laryngoscope blades
- Tip: Perform your own internal investigation prior to government audit
- Q&A: Incidental disclosures and patient privacy
- Q/A: Coding for telescopic intraocular lens
- What does case-mix index mean to you?
- HIPAA 5010 deadline extended, but threat remains, says AMA
- E-mailed
-
- Running an effective peer review committee meeting
- HIPAA Q&A: Flu shot requirement for hospital employees
- What does case-mix index mean to you?
- HHS task force: Consider privacy, security with text messages
- Featured blog post: Nurses face felony charges after reporting physician to the Texas Medical Board
- Tip: Correctly code bilateral pain management procedures
- 2012 CPT code changes for ASCs: Shoulder and knee scopes and pain management
- COT basics to best
- Documentation and coding for toxic metabolic encephalopathy
- Guidance and tact key to compliant, effective physician queries
- Searched