Pharma Industry News Update: 31 Oct 2017

Five Regulatory Myths About FDA Regulation of Pharma in the Digital Health Arena
Can They Be Busted?

[From] Bio/pharma is desperate to offer new value to patients, providers and payers, and digital can unlock both clinical and economic outcomes.

Are you heartbroken when these companies barely dip their toe in the digital waters due to fear of regulation?

At least some regulatory fears are rooted in myths rather than facts. By busting these myths, bio/pharma can more confidently enter the digital health market.


  1. FDA wants to tightly regulate bio/pharma software.
  2. Companion digital health developers always create regulatory risk for bio/pharma.
  3. Any clinical trial software will be regulated as a medical device.
  4. Any bio/pharma software must be approved via a supplemental NDA.
  5. Bio/pharma companies must report adverse events in any databases they touch.

Learn more about these myths…

Social Media in Phama
SMi’s 10th Annual Social Media in the Pharmaceutical Industry conference will be bringinga global presence from GSK, Pfizer, IBM, Janssen, Roche Diabetes Care,Bristol-Myers Squibb, MSD, ABPI, and more. With an agenda full ofexciting and new approaches for communicating with patients online,dive deep into topics surrounding social listening, interactions andengagement, writing effective content and tracking ROI from socialmedia.

SMi Group are delighted to welcome your insights and have you join thediscussions at the 10th annual Social Media in the PharmaceuticalIndustry conference, this January 22nd – 23rd, 2018.

Join us on an exciting journey this January, to answer key questions including:

  • Understanding customer conversations online.
  • How to map out and understand a patient’s journey.
  • How Janssen and Bristol Myers-Squibb have created powerful pharmaceutical social media and digital strategies for patient engagement.
  • Discuss the potential of wearable technologies creating behavioural changes for patients with UCB.
  • Learn to build an integrated, impactful social media strategy with Pfizer.
  • How MySugr can be used as a central point of diabetes care?
  • How to reach doctors on mobile devices?
  • Discover with GSK how to make your social media content less “promotional” and more about storytelling.
  • Content as the metric for engagement?

The event will gather top pharma and social media experts shaping up the digital landscape in a booming market including: ABPI,Bristol Myers Squibb, Creation, CredoWeb, Decision Resources Group,Figure 1, GSK, IBM,, Janssen, Merck & Co., NexGenHealthcare Communications, Novalac, Pfizer Ltd, Roche, Sermo, UCBPharma, ZS Associates and more!

Click here to view the full agenda and register today with your exclusive discount code: MACK100 to save £100 off the conference price! We hope to see you in London this January!

Sponsored by SMi

Trump Has Not Grasped What’s Needed to Combat the Opioid Crisis
Channels Nancy Reagan

[From] In what was billed as a major speech on Thursday, Mr. Trump demonstrated that he has not grasped what’s needed to combat the opioid problem and, more important, the ways in which his own policies impede recovery for millions of Americans.

He declared the opioid epidemic a national public health emergency, which sounds urgent but doesn’t free any significant new money to fight it. In doing so, he ignored the plea of his own opioids commission to declare a full-on national emergency, which would immediately free billions of dollars for emergency response, addiction treatment and efforts to stop the flow of illegal opioids into the country – a comprehensive approach that is so far missing.

Combine this with his repeated attempts to gut health care for poor and middle-class Americans, and the president has offered few tangible solutions for a scourge that now kills about 50,000 Americans a year.

Mr. Trump said he would address the flow of deadly, illegal synthetic opioids into this country during his coming trip to China, and repeated old promises to stop drug trafficking from Mexico by building the wall.

He said the administration would produce “really big, really great advertising” aimed at young people because, “If we can teach young people not to take drugs, it’s really, really easy not to take them.” This is sloganeering reminiscent of the ineffective, Reagan-era “Just Say No” programs, when the ravages of drug abuse in black and Hispanic communities were treated with harsh punishment, rather than the empathy and care that is being called for today.

PharmaGuy’s Insights:

I predicted that Trump would bring up the issue of Mexico and the wall. I also predicted that Trump would revive the old “Just Say No” approach. Read Thoughts on Trump Declaring Opioid Epidemic a National Emergency


Dancing with Fentanyl: Insys Sales Reps Caught Rapping to Boost Sales
You can’t make this stuff up!

[From] According to Huffington Post, “Pharmaceutical sales representatives selling an opioid-based drug 50 times more powerful than heroin filmed a company-made rap video in which they danced with a giant bottle of their deadly fentanyl spray, a federal grand jury alleged in an indictment unsealed this week (for more about that, read “Founder of Insys Indicted for Bribing Docs to Illegally Prescribe Fentanyl. Lock Him Up!“).

The video ended with the company’s vice president of sales removing the Fentanyl Spray costume, revealing his identity. The vice president of sales, Alec Burlakoff, was previously indicted back in December. Burlakoff has been accused of trying to boost drug sales by controversial means before.


Further Reading: