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Andrea Fuller's picture

FDA’s New Social Media Guidelines – How Do I Handle Unsolicited Inquires for Off-Label Uses?


The days of looking up contact information in the[[wysiwyg_imageupload:113:]]
yellow pages has become obsolete. These days we take to the Internet to find out information about whom to contact, and expect to find it quickly and easily. If you were a new visitor to your company’s site would you be able to find the best person to answer your question quickly and easily? If you’re not sure, go take a look.

The Basics of Handling Unsolicited  Inquiries – Off-Label

The FDA understands customers will contact your company requesting information about off-label uses for prescription drugs or medical devices. The question is not if you should handle it but rather, how you should handle it. The answer is good customer service.

Research and online behavioral analysis (Nielsen Norman Group) show time and time again the majority of people prefer the ability to contact a real live individual over a generic contact form or email address. Read full post »

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

Corporate Social Responsibility (Not That Kind)


According to Wikipedia, Corporate Social [[wysiwyg_imageupload:112:]]
Responsibility (CSR) is described as “embracing responsibility and encouraging a positive impact through a company’s activities on the environment, consumers, employees, communities, stakeholders and all other members of the public sphere.” Perhaps we should reconsider this description and think of those words as they relate to Pharma in the online/social media space.

During a recent conference on the social/digital space, there were many examples of how Pharma can engage online. But, even with the positive examples given at the conference, our day-to-day experience can paint a different picture. Stung by warnings and violation letters, the Pharma world is very cautious of talking about their company, let alone a product, in the social media space. Read full post »

Tim Weinheimer's picture

Is Your Web Domain in Order for Responding to Unsolicited Requests?


The process of prescribing, dispensing and using [[wysiwyg_imageupload:111:]]
medications leaves little room for medical errors when the health of the consumer is at stake.

The same holds true in making sure there is no room for error in “dispensing” prescription drug and medical device information on your web sites. The new FDA guidelines present the opportunity to ensure your customers can and will find readily accessible and accurate off-label information across your company and branded web properties. With the new FDA guidance for responding to unsolicited requests for off-label information, it may be time for a cross-domain audit of your web properties – an audit to simply ensure such off-label information is current and meeting FDA requirements.

Per the FDA recommendations, a firm’s contact and disclosure information, a public response should include a mechanism for providing readily accessible current FDA-required labelling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer, FDA-approved patient labelling or, for new animal drugs, FDA-approved client information sheet. Read full post »

In: Digital & Social Media  /   filed under: FDA | Social Media | website
Diane R. Johnson, MPH's picture

The New Real World: Transparency and Innovation in Government


With the 24-hour news cycle, new and social [[wysiwyg_imageupload:109:]]
media at our fingertips, and even a presidential initiative on “transparency and open government” — federal agencies must adapt to this change in paradigm. The Food and Drug Administration (FDA) along with the Centers for Medicare & Medicaid Services (CMS) recently held a summit in Washington, DC, where its top policy makers engaged biotech and pharmaceutical executives in an open dialogue on driving pre- and post-regulatory approval and commercialization strategies for products coming to market. Read full post »

Alexander Watson's picture

PR and Patent Cliffs 2012: Could We Be Seeing the End of “Big Pharma” as We Know It?


[[wysiwyg_imageupload:108:]]As patent cliffs continue to crack and crumble into the sea and send shock waves through big pharma around the world, global healthcare PR strategists continue to train their skilled teams’ eyes and ears on the future trends of big pharma, urgently trying to discern the shape of the new emerging landmass to keep ahead of the game.

Over the next three years, six Big Pharma companies have more than half of their portfolio at risk due to patent expirations.  I’d imagine that this creates anxiety among communications agencies around the world asking what this all means for them and future revenue streams. Should we start prophesying that the end is nigh for “big pharma”? Long-term, can viable business models continue to be sustained around portfolios of products that have such short patent shelf lives? Read full post »