Week in Review, January 28, 2014

Sunshine and state-accredited CME are clarified at a conference, the Supreme Court weighs in on medical device patent infringement, China institutes a new program to monitor healthcare and a new study shows the industry is still wary of social media.

Go west, young man…if you want to escape this arctic cold that is. It was another week of super cold weather, snow showing up in unlikely locales (you saw all the memes about Austin, TX, right?), frozen pipes and below zero wind chills. When Anchorage, Alaska is warmer than Atlanta, GA, you know we’re having cold weather here in the east. To make matters worse, another blast of arctic cold is on the way. The only escape seems to be the western part of the country, where temperatures in the 80’s and sunshine are thriving. The rest of us will just have to huddle around the fireplace and catch up on all things compliance, with this week’s News in Review.

The topic of Sunshine and state-accredited CME programs heated things up at a recent continuing education conference. A CMS representative speaking at the conference mistakenly indicated that state accredited CME programs were not exempt under Sunshine. The final rule actually refers to both certified and accredited CME and does not draw any clear lines between the two distinctions. After hearing how the process actually works, the CMS representative realized that the state-accredited CME would qualify for exemption.

The U.S. Supreme Court iced out patent holders in a recent decision. The Court unanimously ruled that patent holders bear the burden of proof in patent infringement cases, even if they received a declaratory judgment. The case at the center of the ruling involved Medtronic and Mirowski Family Ventures,LLC. Mirowski holds patents for implantable heart stimulators, and Medtronic had a license agreement to use those patents. The company claimed Medtronic infringed its patents, but a federal court ruled Mirowski  had not met the burden of proving infringement. The case was appealed and a U.S. Court of Appeals reversed the ruling, saying Mirowski set the events in motion and that there was “no convincing reason why burden of proof law should favor the patentee.”

The FDA has discovered a new way to submit nominations for its advisory committees. The agency announced the launch of an interactive online portal for the submission of advisory committee nominations. Applicants can submit their entire application through the new portal. The FDA says the system will eliminate confusion and accelerate timelines for submission and acceptance.

China is cranking up the thermostat with a campaign to deal with bad manufacturing and marketing practices in healthcare. The inter-departmental campaign involves eight different departments in the Chinese government. Officials hope to also use the program to deepen reform efforts in medical services.

A new report shows much of the industry still feels chilly about social media. The report from IMS Health indicated that 23 of the top 50 companies worldwide are using Facebook, Twitter and YouTube. However, only 10 of the companies are using all three, and very few are using social media to engage patients. Most are using social media as a way to deliver messages intended for providers and patients alike. Companies with a small therapeutic focus tend to use social media more to engage the patient. In an interesting twist, the study also found that regulators are quite active on social media. The FDA and EMA post high index reach scores, and the FDA scored higher than any pharmaceutical company on IMS’ relationship scale.

We certainly hope everyone stays warm and safe as the next arctic express heads east. We’ll be venturing out into it ourselves for CBI’S 11th Annual Pharmaceutical Compliance Congress. If you’re there, stop by our booth in the exhibit hall to say  hi and see a demo of our new Compliance Curriculum Refresher Training series.

Stay warm everyone!

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