Friday, August 14, 2015

This week in ePharma: FDA issues a warning to K. Kardashian's promoted morning-sickness drug

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FDA issues a warning to Diclegis, the morning-sickness drug promoted by Kim Kardashian
In the week of July 24th it was announced that Diclegis has partnered with Kim Kardashian in promotional efforts of the new morning-sickness drug. This week the FDA has issued a warning over K. Kardashian's drug promotion on social media. In particular, it was stated that there was a violation of the federal drug-promotion rules. The reality star has never mentioned any side effects in her testimonial statement favoring the drug on Instagram. On August 7th the FDA has posted a warning letter addressing the drug's and Kardashian's promotional efforts as misleading and indicating that the social post was submitted as a complaint to the OPDP Bad Ad Program, the program that was designed to monitor and supervise the truthfulness of the prescription drug advertising and promotional efforts.

Roche Pharma Research & Early Development has developed a smartphone app to continuously monitor changes in patients with Parkinson’s disease. The hopes are the app will be able to collect data that can significantly improve medicine development program in Parkinson’s disease. Currently the app is in Phase I trial run with the the help of Prothena, a late-stage clinical biotechnology company that focuses on discovery, development and commercialization of programs with aim of potential treatment of diseases.


With the team of researchers from Oxford, Cambridge and London with backgrounds in medicine, behavioral health, bioengineering, design, and software the startup Hinge Health has set a goal to improve the lower back pain for many employees who spend most of the day at their desks, and help their employers reduce absenteeism and health costs. Hinge Health has produced a program that consists of physiotherapy, personalized coaching, weight loss, ability to tracking progress, and peer support opportunity. The program is a package that includes sensor bands, a tablet computer with software, and a number of other accessories. Based in London, the Hinge Health startup is currently aiming at the US market.


FDA has lost a battle for off-label marketing if the claims are truthful.
On August 7th the federal judge of the Federal District Court in Manhattan Paul A. Engelmayer has ruled that off-label marketing can be done legally even if the FDA has not approved for as long as the claims are truthful based on the First Amendment (Freedom of Speech.) This precedent sets the history, because in the past many companies have lost this fight in court and ended up paying large settlements.

Here you can read How to Recognize and Report Off-Label Pharmaceutical Marketing.


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About the author: Ksenia Newton, a Digital Marketing Assistant at IIR USA, Pharma Division, who works on various aspects of the industry including social media, marketing analysis and media. She can be reached at knewton@iirusa.com
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