FDA

Tim Weinheimer's picture

Top Three Tips for Meeting FDA’s New Interactive Promotional Media Guidelines

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With the FDA release of its latest guidelines on[[wysiwyg_imageupload:170:]]
the use of new interactive promotional media there are new opportunities for PR professionals. The FDA’s new report is titled “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” and within the report there are 3 opportunities for PR professionals related to managing online influencer relationships and FDA-approved content optimization.

The Top 3 Tips:

“Representatives” or agencies can squarely sharpen their communications outreach in 2014 in response to these new guidelines by taking the following steps to digitally optimize their clients’ campaigns for success.

 

1.    Subscribe to influencer database tools and software. Read full post »

Joe Wagner's picture

The Evolving Rules of Social Media and Healthcare

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At a recent FDA/CDER-CHPA seminar on
promoting Over the Counter [[wysiwyg_imageupload:143:]]medicines in a social media world
, experts wrestled with the fact that consumers are increasingly turning to others like themselves or other online channels for health information, data, and first-hand experiences to help them make better medical decisions. Almost half of consumers are reading someone else's commentary or experience about health or medical issues on an online news group, website, or blog. They are turning to social channels and platforms because they want customer service, immediate answers to basic questions, guidance and someone to make sense out of the cacophony of medical information. Read full post »

Chartése  Day's picture

Pharma’s New Cliffhanger: Protecting Corporate Reputation in the Face of a Prescription Drug Abuse Epidemic

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For the pharmaceutical industry, most have [[wysiwyg_imageupload:132:height=126,width=191]]
focused on the crisis of the patent cliffhanger: the loss of more than $30 billion in revenue due to patent expiration of prescription drugs once dubbed “blockbusters.”

However, a greater crisis awaits - one that impacts not only a company’s bottom-line, but also a pharmaceutical company’s greatest asset: its corporate reputation. Companies must brace themselves to handle the industry’s role in combating the prescription drug abuse epidemic.

While most major causes of preventable death are declining, drug overdoses are an exception. And, opioids seem to bear the brunt of the blame. A 2011 report from the Centers for Disease Control and Prevention revealed that most drug-related deaths were not the result of illicit drugs, such as heroin or cocaine, but instead were the result of prescription pain medicines, mainly opioids.  Inappropriate use of opioids caused nearly 342,000 emergency department visits in 2009, according to government figures. The drugs were blamed for 16,000 deaths that year, up from 14,800 in 2008. Read full post »

Andrew Lamb's picture

A European Perspective on Social Media and the FDA’s New Guidance

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While it falls short of the comprehensive guidance [[wysiwyg_imageupload:115:]]
on social media that many were hoping for, the FDA’s new document on responding to unsolicited requests does have an interest and relevance for those working in healthcare communications on the other side of the Atlantic.

Of course, no digital project is completely ‘local’ and Europeans should always have half an eye on developments elsewhere in the world. More importantly though, the FDA has given us a useful clue to what regulators are thinking and the issues they face in coming up with clear rules for the rapidly evolving environment of the web and social media. It could also set the tone for European guidance, if and when it appears.

The most significant aspect of the FDA’s new document is that: Read full post »

In: Digital & Social Media  /   filed under: EU | FDA | pharma | Social Media | UK
Suzannah Palinkas's picture

We Must First Ask the Question - What Do We Want to Accomplish?

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It seems simple enough and a logical first step to [[wysiwyg_imageupload:114:]]
planning anything but so many times, across multiple disciplines, we hear:

“We need a Facebook page.”

“We need to have a blog.”

“We need to be Tweeting.”

But why? At a recent social media conference, specifically in the Pharma space, the question and principle came up multiple times… we need to start by asking a few simple questions. What are we trying to accomplish? Reaching who? What then are we going to do with the information? Why do we need to be in the social media space?

One can’t deny that online vehicles are growing rapidly, exponentially expanding, and that social media channels are just too large a communication vehicle to ignore. Even so, there has to be the right fit between what a company wants to accomplish online and the vehicles through which it achieves those goals. And it seems that sometimes those key questions haven’t been answered, and the result is an inappropriate or useless execution that simply checks a box. Read full post »