The new FDA guidelines for

2014 is shaping up to be a year for new standards. Last week I looked at the new SEO standards for press releases, now it is time to take a look at social media standards in the drug industry.

Many pharmaceutical companies have been hesitant to dip their toes in the social media pool due to lack of guidance on how to do so legally. Since the industry is bound by extremely strict rules and requirements, this anxiety is well founded.


Pharmaceutical advertising is subject to tight joint regulation by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). All promotional materials must pass their regulations, which have no language concerning social media.

The Regulatory Affairs Professionals Society (RAPS) notes how these existing strictures dovetail (or don’t) with modern, online media:

Each advertisement must contain a variety of elements, including facts backed up by substantial and cited evidence, a full accounting of risks, a ‘fair balance’ of benefits and risks of the drug, the generic name of the drug, any serious warnings such as Black Box warnings and more.

The amount of information required, in other words, is extensive.

So how are companies to marry the extensive information requirements of traditional advertising, like television and print media, with emerging social media platforms used by billions? Take Twitter’s 140-character limit, for example: Could a company compose even a single tweet that contained all the elements required by FDA? Should it even try?

At stake is nothing less than access to consumers in the new media environment, one in which those consumers are increasingly eschewing television and magazines for YouTube and Facebook.

The FDA repeatedly has confirmed that a full guidance document on social media — one required within two years by The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 — is on track for release in July of this year. Source: ( Of course, that is still six months out, if it is released on time. In the meantime, a week ago the FDA released a preliminary guidance documentFulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics. It primarily cover the thorny issue of how companies can submit their materials for FDA review.

Let’s look at the important bits.

Third-Party Content

In the draft the FDA notes that companies are generally not responsible for the following types of third-party content:

  • ‘Truly independent content’ defined as content not produced or solicited by the company in question.
  • Content published on websites financially supported by the company, but over which the company has no editorial control.
  • Material found on third-party websites that is not directed by the company, and as long as the company has no influence or control over the website on which those materials appear.

Reporting requirements

Real-time media poses a distinct challenge when it comes to reporting, but a manageable one now that there are guidelines on how to do so. For example, a company using Twitter now must submit information to the FDA on a monthly basis, including a listing of all websites involved. According to the new guidelines, the URLs to the firm’s social media accounts would be sufficient as long as access to the sites remains unrestricted. Notably, no screenshots of conversations will be required. Here are the high points:

  • Sites controlled by third parties on behalf of the company are subject to the same monthly reporting schedule noted above.
  • The FDA requires notification ‘on the first day the firm ceases to be active on a site.’
  • If a site is restricted, the firm’s monthly reporting should include screenshots or other visual representations of the interactions there.

More to come

It looks like social media, or as the FDA calls it, “interactive promotional media,” is getting recognition as a legitimate channel. Thanks to this draft, pharma companies now have a framework within which they can begin to explore the vibrant digital ecosystem. From disease awareness to promotion of new products, the possibilities are extensive. I feel safe in saying that pharma’s engagement on social platforms will be a much-discussed subject.

In the meantime it would behoove members of the pharma industry to become familiar with the new rules.

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