Health Policy & Regulatory

Get informed about health policies and regulations that set in motion the vision of future healthcare.  Read what our healthcare communications leaders internationally think about the ongoing developments in healthcare legislation, health reform, and more.  We encourage comments and discussions! Share your opinions and ideas to readers like yourself and our bloggers.

Recent Blog Posts

Casey Myburgh's picture

21st Century Cures Act: A Prescription for Change?

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Late last week, the U.S. House of Representatives approved the 21st Century Cures Act, legislation that is designed to streamline the U.S. Food and Drug Administration (FDA) drug approval process and fundamentally change how the pharmaceutical industry does business, “from the discovery of clues in basic science, to streamlining the drug and device development process, to unleashing the power of digital medicine and social media at the treatment delivery phase,” according to the House Energy & Commerce Committee.

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Alison Rogove's picture

FDA Webinar on Social Media Draft Guidances: Still Seeking Long-Awaited Clarity

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[[wysiwyg_imageupload:212:height=154,width=188]]Healthcare consumers, patients and professionals are relying more and more on digital and social media forums, and online resources for medical and health information. Healthcare knowledge sharing via social media is also a growing practice. As digital and social engagement on health continues to grow, so do questions on best practices for industry, such as pharmaceutical companies. On July 10th, the U.S. Food and Drug Administration (FDA) hosted a highly-anticipated webinar and public Q&A session to discuss its stance on the use of social media by the healthcare industry (slides available here). Specifically, the FDA addressed three draft guidance documents it has issued in recent months, all with one common goal – to help shed some light on how the industry can join this powerful conversation.

 

What were the key takeaways from the FDA’s session? Read full post »

Casey Myburgh's picture

When Definitions Change: Autism and the DSM-5

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Autism does not look the same from one person[[wysiwyg_imageupload:181:]]
to the next. 

It is unique in each diagnosis, showcasing different challenges and attributes for all. Along the autism spectrum, people share a wide range of developmental and social abilities, which poses challenges when defining and diagnosing autism. This past week, the U.S. Centers for Disease Control and Prevention published new findings that report a staggering one in every 68 children has autism spectrum disorder (ASD). The community understandably has concerns about the updated statistics. However, the inconsistencies with diagnosing – and misdiagnosing – autism led to the American Psychiatric Association fifth edition update of the Diagnostic and Statistical Manual of Mental Disorders, (DSM-5) in 2013.

What’s new in the DSM? Read full post »

Kimaya Dixit's picture

FDA Opens Up Social Media to Pharma Companies with New Guidelines

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When it comes to social media in the pharma [[wysiwyg_imageupload:174:]]
space, PR and communications professionals have fought a very long and laborious battle. Fortunately, the U.S. Food and Drug Administration (FDA) has finally come through with new and officially issued guidance for pharma's interactive marketing activities online. While this certainly clarity to an otherwise dark and restrictive social media-pharma terrain, there are a few bumps along the way to keep in mind.

First and foremost, there is no denying that the somewhat unrestricted freedom to tweet, post, blog, pin, etc. is right in line with where the future of real-time reporting and health PR is headed. These guidelines will most likely lead to real-time interactive marketing initiatives quickly slipping into PR strategies for pharma companies, both big and small. Read full post »

Jon  Hendl's picture

It’s Time to Resurrect the Public Health Focus on Smoking

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Fifty years ago, the first ever U.S. Surgeon
General’s report on smoking
on [[wysiwyg_imageupload:172:]]health was released. Among other things, the report concluded that lung cancer and chronic obstructive pulmonary disease (COPD) are caused by smoking.

Fast forward to 2014, and we find that lung cancer is the leading cancer killer in the United States, claiming 158,000 lives annually, and COPD is the nation’s third leading cause of death, claiming 134,000 Americans annually. As diseases like breast cancer adorn the jerseys of professional players, lung cancer and its primary cause – smoking – can’t even get an invitation to a try out. Read full post »