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FDA: We’ll issue social media guidelines later this year Consumers: Who cares !

Sunday, February 28th, 2010

Frankly I don’t care when and if the FDA issues guidelines around social media. It isn’t going to make one bit of difference for patients or consumers because in order to have a relationship you have to trust the person your engaging with and consumers don’t trust the drug industry or the FDA. Just a little while ago the FDA sent a letter to a drug company because they dared to simply the language on their website in a way that makes medical information easier to understand

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Six million asthma patients wondering what to do now

Friday, February 19th, 2010

If your a patient who is taking either Advair or Symbicort you’re probably either very confused this morning and wondering what the hell you should do next. The FDA wants you to stop taking these medications and talk to your doctor about your asthma treatments.

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FDA Ad Division Objects To User-Friendly Efficacy Claims With Jargon

Monday, February 8th, 2010

The Astelin (azelastine HCl nasal spray) letter, citing a waiting room sign for the allergy drug, DDMAC objects that “in contrast to the consumer-friendly claims on the sign, some of the risk information that is disclosed (i.e., ’somnolence’ and ‘rhinitis’) is presented in medical terminology that is not likely to be understood by consumers.” Similarly, the citation of a patient brochure for OraVerse states that: “While the patient brochure presents efficacy claims for OraVerse in language that is easily understandable to consumers, it presents risk information using complex medical terminology that is not likely to be comprehended by the same audience.” Both citations rely on the prominence standard: FDA considers ads to be misleading “if they fail to present information about the risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug.” What does this mean for the drug industry and patients? It means that they are likely to continue to be confused by the language that the FDA wants and it means that the drug industry may not be able to engage and talk to consumers & patients via social media without using the label as the script.

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Once again the FDA gets it wrong when it comes to fair balance

Sunday, January 3rd, 2010

“As consumers utilize a wide variety of sources to learn about prescription medications, it may not be optimal for the FDA to require that pharmaceutical companies include the same details in each of the channels they use to communicate information about their prescription drug products,” said Morris S. Whitcup, Ph.

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Fair Balance: Consumers want better disclosure. Another action item for the FDA

Sunday, January 3rd, 2010

“As consumers utilize a wide variety of sources to learn about prescription medications, it may not be optimal for the FDA to require that pharmaceutical companies include the same details in each of the channels they use to communicate information about their prescription drug products,” said Morris S. Whitcup, Ph

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Customized Patient Ed & Other Research Preliminary Findings

Saturday, November 7th, 2009

Patient Research The objective of this research was to learn both how patients search for health information on the Internet and how they determine which information is actionable towards requesting a specific healthcare treatment. Some of the preliminary findings: -Patients search for health information is driven by specific triggers with those triggers being symptoms of a health problem, information in preparation for a physicians office visit, after a diagnosis. Interesting to note that women are more proactive where men are not

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We asked and Physicians sounded off

Monday, October 26th, 2009

The goal of this research was to determine how physicians felt about medical information on health website. While I heard that they were supportive they also voiced concerns about misinformation and online tools that patients often use for self-diagnosis

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The FDA is doing little to inform and educate for Rx and OTC products alike

Thursday, July 2nd, 2009

Just look at some of the stories this week when it comes to OTC or Rx products: -Possible links between Lantus and cancer. -Acetaminophen products can cause liver damage or death if not used correctly.

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