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New regulatory tool: the “FDA Advisory Bouquet”

Director, Digital Insight

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In a surprise move today the FDA has released its much anticipated Draft Guidance for the Use of Social Media by Pharmaceutical Companies to Empower Patients and Improve Care which contains both social media guidance and a new enforcement option for the agency.

This was an April 1 post from 2013, it has no relationship to the FDA’s Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.

The document is a treasure trove of regulatory goodness and looks to be aimed at allowing pharmaceutical companies to share important product information with the inclusion of some “safe harbor” provisions. These provisions allow pharmaceutical marketers to engage in social channels without risking a slap on the wrist by the FDA watchdogs.

Thomas Abrams, Director of the OPDP said in a statement:

“We have been thinking long and hard about this, and while we really enjoy pointing out the regulatory flaws Pharma Marketers’ campaigns, we decided that the patient need in this case took precidence. Our office pool about who would get the next letter will be converted to a fantasy football league.”

Klick Health will be poring over the 8,000+ page document over the coming days but for now the provisions seem to center on the following abilities:

The ability to answer questions

If patients ask questions on social media, the pharmaceutical company will be allowed to answer in the same channel. This includes the ability to state or imply the product indication and have the ISI linked from the social channel when there is insufficient space to include it directly.

The ability to correct misinformation

When misinformation is found anywhere on the internet the pharmaceutical company will be allowed to correct it without accepting responsibility for the entire site on which it was found.

Wikipedia exception

By working directly with Wikipedia founder, Jimmy Wales, the FDA has been able to secure a special lock on pharmaceutical topics so that changes to those topics will be required to go through a pharmaceutical company’s regulatory process before being accepted. This carries with it the burden of ownership of the content, but the benefit that the number one resource for drug reference information is kept accurate and up-to-date. Wales said in an interview:

“Our editors are fine with technology subjects but they really don’t know what they’re talking about regarding drugs, this change will ensure higher information quality on Wikipedia and better patient care.”

Patient adherence provision

Pharmaceutical marketers will be interested in the ability to enhance patient support programs with social media elements to help with persuasive design. By including friends and family on therapy adherence topics, these programs can influence patients to remain compliant with the FDA’s blessing.

New FDA disciplinary tool

The FDA Advisory Bouquet will convey a second layer of meaning in the choice of flowers. Remember, if you don’t know what you did wrong then you’re just being insensitive.

The FDA has decided to do away with warning letters for social media issues, instead they have developed a new tool called the “FDA Advisory Bouquet”.

As the name suggests, when the FDA finds an issue relating to a brand’s use of social media they will use FTD to send a festive bouquet of flowers with a small note attached. The note will express their worry, be it expansion of indication, lack of ISI, overly optimistic patient testamonials, etc. It is rumored that the type of flower will convey some subtext about the FDA’s feelings about the issue, but these will not be stated directly.

Abrams reinforced the importance of the FDA Advisory Bouquet:

We really want this new relationship to work, and that means that the industry needs to understand our needs and feelings. To date we don’t feel like we’ve been heard and it’s not like we haven’t been clear—industry simply doesn’t listen to us. This new tool will be chock full of subtext and we expect the industry to understand it. Or else.

Important Safety Information about THE FDA BOUQUET (floristamib)

Indication

Who should NOT read THE FDA BOUQUET

Warnings

Please see the full Prescribing Information to get the details on THE FDA BOUQUET.

Happy April Fools from Klick Health!

More About the Author

Brad Einarsen

Brad is Klick's Director of Digital Insight, supporting our Strategy, Accounts, and New Business groups to gather, disseminate, and make accessible knowledge about our clients, their products, and the markets in which they operate.

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