Pharma Industry News Update: 19 April 2016

Merck Calls for a New Regulatory Framework for Digital Health Apps
Matts Berggren, head of health policy and market access at Merck… believes there should be an established regulatory framework designed specifically for digital health products.

“There are 1000s of health apps out there,” he says, “but most will never be accessed. It is important to identify those of value and bring them into an established regulatory framework. If we do not have that there will be a digital snake-oil out there. There are interventions that are effective and ought to be encouraged but in order to make it economically sustainable for the pharmaceutical industry we have to have the right regulations in place,” he said.

An effective regulatory framework can help drive up standards and quality but many argue the lengthy clinical trial model is not compatible with the dynamic and ever-changing digital world. It is often seen as an obstacle to rapid product development. Pharma can either see it as an opportunity or a threat but either way the industry must find a way to get in on the act and adapt their business models accordingly.
 More here.

Want to Know Which Federal Laws Apply to Your mHealth App? HHS Has an App for That!
Does your mobile app collect, create, or share consumer information? Does it diagnose or treat a disease or health condition? Then this tool will help you figure out which – and it may be more than one – federal laws apply. It’s not meant to be legal advice about all of your compliance obligations, but it will give you a snapshot of a few important laws and regulations from three federal agencies.

  • Health Insurance Portability and Accountability Act (HIPAA)
  • Federal Food, Drug, and Cosmetic Act (FD&C Act)
  • Federal Trade Commission Act (FTC Act)
  • FTC’s Health Breach Notification Rule


Another Dark Disease Awareness Youtube Video from Boehringer
Boehringer Ingelheim (BI) is leading the pharma industry in posting disease awareness videos on Youtube. Several focus on cardio-respiratory conditions such ad COPD. See, for example, “2 SIDES OF LIVING WITH COPD,” which I said “Tugs at Heart Strings, Then Scares the Bejeezus Out of Us! Is it necessary to pull at our heart strings and then bring us down with scary death mask-like imagery?”

Well, if you thought that video was scary, you might “shi* your pants” watching “How does it feel to live with IPF?”, which is an even scarier, disease awareness video from BI. IPF is shorthand for Ideopathic Pulmonary Fibrosis – a disease in which tissue deep in the lungs becomes thick and stiff, or scarred, over time. It usually affects middle-aged and older adults. BI markets OFEV for treating IPF.

The video features a dark image of a woman starring off into the dark sky. But there’s something even odder, more ominous about this video.
Found out what it is here.

How Digitally-Advanced is Pharma Compared to Other Industries?
Recent research from the McKinsey Global Institute (MGI) looked at the state of digitization in sectors across the U.S. economy and found a large and growing gap between sectors, and between companies within those sectors. The most digital companies see outsized growth in productivity and profit margins. But what are the key attributes of a digital leader? And how can companies benchmark themselves against competitors? We looked at 27 indicators that fall into three broad categories: digital assets, digital usage, and digital workers. Our research shows that the latter two categories make the crucial difference.
Find out where pharma stands here.

The Pharma Social Media Achievement Award “Before they’re slaughtered, each one gets an achievement award.”