For pharmaceutical companies regulation matters, even on social media

For pharmaceutical companies regulation matters, even on social media

It may have taken the FDA a while to start regulating copy related to pharmaceutical products on social media, but rest assured: the day has come.

Recently, the FDA sent a nasty letter to Institut Biochimique and its U.S. partner Akrimax Pharmaceuticals about its Facebook page for Tirosint (levothyroxine), a thyroid medication. It turns out, the brand left a few key details out on its page, including:

  • Tirosint shouldn’t be used in patients with one particular type of hypothyroidism

  • The drug’s boxed warning that it shouldn’t be used to treat obesity or for weight loss

  • The drug’s risks

Message received: proper disclosure of risks and benefits is just as important on social media as anywhere else for pharma.

A difficult field to govern

The FDA has been struggling to determine its policy on social media. Last year, it nodded its head vigorously when the FTC released guidelines for social media and mobile advertising. While it is a challenge to provide full disclosure in 140 characters, the FTC said it was required:

Full-disclosure rules apply even to space-constrained ads, such as those in the Twitterverse and on Facebook. Ads have to be labeled as such, and any required disclaimers or qualifications have to be included. The so-called fine print has to be easy to see and understand. And if the required disclosures don’t fit, then the ad has to be rewritten.

Because this is similar to what the FDA requires for other types of ads for pharma, many speculated that it would also adopt these guidelines as it continues to build out its stance on social.

In January 2014, the FDA released guidelines for posting to social sites. Pharmaceutical companies would not be required to submit every tweet, pic, or status update beforehand for approval. (Can you imagine the deluge of content they would then be required to review if they hadn’t decided this?) Companies would, however need to submit their social accounts monthly for review to ensure they remained compliant.

And yet, there’s still be much nebulous speculation around what the FDA really wants. When it questioned the validity of Likes on Facebook, many pharma folks cried out.

What DOES the FDA want?

Here is what the FDA released in January:

• Firms are responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm

– Such product promotional communications may include firm-sponsored microblogs (eg Twitter), social networking sites (eg Facebook) and the firm’s blog

• Under certain circumstances, firms are responsible for promotion on third-party sites

– Companies are responsible for such promotion if they have any control or influence on the third-party site, even if that influence is limited in scope

A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product

– Companies are responsible for content generated by its employees, or any agents, acting on their behalf who promote the firm’s products

The system isn’t perfect yet, but the FDA continues to work out the kinks, and plans to have a full list of guidelines in place by Summer 2014.how-to-improve-your-pharmaceutical-translation-process

Photo:PhotoSpin

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