Week in Review, March 4, 2013

The PharmaCertify™ Team

No doubt you’ve seen the ads already – storage bins, cleaners, mops, brooms, vacuums – available everywhere, from the big box stores to your local hardware store. Spring cleaning is just around the corner, but before you run off to stock up on your supplies, let’s take a look at what’s been sweeping through the world of compliance, with the News Week in Review.

Could the FDA be starting to clear some of the cobwebs around social media marketing? The agency took issue with the use of a company’s Facebook “like” of an unsubstantiated claim. The company, a dietary supplement manufacturer, received a warning letter citing multiple violations associated with its drug product, Poly-MVA. The letter included the complaint about the company “liking” a product testimonial, which concerned the FDA because the claims made in the testimonial could not be substantiated by good science.

The temperatures are warming and according to a study by Deloitte, Sunshine is spreading around the world. The study shows that by 2015, 70% of drug sales will occur in countries with payment disclosure requirements.

Not everyone is warming up to the idea of Sunshine though. The BioIndustry Association in the UK is questioning whether the benefits of transparency are worth the aggravation and added requirements. The organization’s chief executive, Steve Bales, says the transparency requirements could put early stage research investment at risk. His members are nervous about some of the early phase research reporting requirements. In addition, a representative from the Medical Research Council’s clinical trials group raised concerns about the potential for an increased workload due to the new requirements.

The DOJ is planning on being more aggressive about cleaning up violations of current Good Manufacturing Practices (cGMP), according to Deputy Assistant Attorney Maame Ewusi-Mensah Frimpong of the agnecy’s Consumer Protection Branch (CPB). CPB worked closely with the FDA and was involved in recent settlements with GSK, Abbott and Merck involving consumer safety issues and marketing claims. Ms. Frimpong insisted that companies failing to follow cGMP practices put consumers at risk, and there was no way for the patient or physicians to know about that risk. Companies need to ensure their employees have access to the  proper training and establish incentives for recognizing and reporting problems, according to Ms. Frimpong.

And so we close another Week in Review. As spring draws tantalizingly near, the PharmaCertify team is hard at work refreshing our list of compliance training and mobile solutions. In fact, now that CMS has released the final rule on Sunshine, we’ve added an eLearning module and iPad app focused on the topic. Contact Sean Murphy at smurphy@pharmacertify.com to see a content outline or demo.

Have a great week everyone!

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s