Detail aid misbrands dermatology drug, says DDMAC
Pharma Compliance Alert, August 1, 2007
A detail aid and journal ad for Doak Dermatologics' product Solaraze Gel recommends or suggests unapproved uses and fails to include the needed risk information, according to an FDA letter to the company.
According to the FDA, the ad and the detail aid suggest that the drug can be used to treat actinic keratoses when used in combination with another therapy. The promotions include before and after pictures, cite a study, and feature a bar graph with data showing the effectiveness of the combination therapy. However, Solaraze Gel is only approved as a monotherapy for treating actinic keratoses, the FDA said.
The PI did not include any information about the safety and efficacy of using Solaraze Gel in combination therapy. Moreover, the Precautions section of the PI says that the safety and efficacy of combination therapy hasn't been studied, contradicting the claims and recommended use that's in the promotional materials.
Finally, the FDA cited Doak for failing to presubmit the journal ad prior to disseminating it.
To read the full warning letter, click here.
Related Products
-
ePharm5 InDepth
EPharm5 e-mail newsletter delivers the top 5 developments in pharma business innovation, with original research, interviews...
-
Big Pharma Performance Before, During and Beyond the Global Recession
This report assesses the performance of the leading 15 pharmaceutical companies up to, during and beyond the recent global...
Most Popular
- Articles
-
- Q/A: Volume requirement for reporting hydration services
- Featured blog post: Nurses face felony charges after reporting physician to the Texas Medical Board
- Catch up on what's new with injections and infusions
- Topic: CMS, OESS post new security compliance review information, checklist
- What does case-mix index mean to you?
- QA:Coding multiple initial infusions
- Capturing all necessary codes for IUD insertion and removal can be challenging
- News and briefs: Oklahoma Osteopathic Association against residency bill change
- OB services: Coding inside and outside of the package
- HIPAA Q&A: Level of encryption needed for email
- E-mailed
-
- Q/A: Volume requirement for reporting hydration services
- Featured blog post: Nurses face felony charges after reporting physician to the Texas Medical Board
- Catch up on what's new with injections and infusions
- New conflicts of interest create new challenges
- What does case-mix index mean to you?
- Joint Commission Center announces handoff communication solutions
- Inside best practice: Reduce patient falls with a stoplight
- Identify modifiable risk factors to prevent patient falls
- Hospitalist-surgeon comanagement has no effect on outcomes
- HIPAA Q&A: Level of encryption needed for email
- Searched