Legal News

FDA Tells How to Tweet About Prescription Drugs and Devices
Download PDF
1 Star2 Stars3 Stars4 Stars5 Stars (No Ratings Yet)
Loading...

fda-logo

The USFDA has published draft guidance (scroll down to read the draft) telling Pharma companies how to tweet about their products, and how to use other “Internet/Social Media Platforms with Character Space Limitations.” The FDA says it does not intend the guidelines to be enforceable as law and mentions, “The use of the word should in Agency guidances means that something is suggested or recommended, but not required.”

With that as the backdrop, the FDA says, “This draft guidance is … about how manufacturers, packers, and distributors (firms) of prescription human and animal drugs (drugs) and medical devices for human use (devices) that choose to present benefit information should present both benefit and risk information within advertising and promotional labeling …on electronic/digital platforms that are associated with character space limitations – specifically on the Internet and through social media or other technological venues (Internet/social media).

  
What
Where


The guidance proposes that when using Internet/social media platforms with character space limitations for product promotion, firms should consider the following points:

—     Benefit information should be accurate and non-misleading and reveal material facts within each individual character-space-limited communication (e.g., each individual message or tweet).

—     Benefit information should be accompanied by risk information within each individual character-space-limited communication.

Get JD Journal in Your Mail

Subscribe to our FREE daily news alerts and get the latest updates on the most happening events in the legal, business, and celebrity world. You also get your daily dose of humor and entertainment!!




—     If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should consider using that platform for the intended promotional message.

While the FDA goes to great lengths to illustrate with examples how this might be achieved, to do that within 160 characters would take some doing.



The FDA, however, does provide a way out by admitting the “Agency is aware of the challenges in balancing benefit and risk information within the character space constraints …” and saying that a concise disclosure of specific risk information accompanied by a link including “prominent reference to the presence and location elsewhere of a more complete discussion of the risks associated with the product …” might suffice.

The FDA has also concurrently published separate draft guidance for “Correcting Independent Third-Party Misinformation” on Internet/Social Media.

[gview file=”https://www.jdjournal.com/wp-content/uploads/2014/06/FDA-tweet-Guidance.pdf” save=”0″]



 

RELEVANT JOBS

Director & Associate General Counsel - Litigation

USA-DC-Washington

How You’ll Contribute The Legal and Business Affairs (LBA) team assists the organization in...

Apply now

VP & Sr. Associate General Counsel, Technology, Operations & Facilities

USA-DC-Washington

How You’ll Contribute The Legal and Business Affairs (LBA) team assists the organization in...

Apply now

Associate Attorney

USA-NJ-Florham Park

Job Description The Law Office of Barry E. Janay, P.C. is a growing law firm with a focus on...

Apply now

Family Law Attorney

USA-OK-Yukon

Bedlam Law is looking for an exceptionally dynamic, highly motivated, self-starter with at least fiv...

Apply now

BCG FEATURED JOB

Locations:

Keyword:



Search Now

Corporate/Transactional Attorney

USA-IA-Des Moines

Des Moines office of a BCG Attorney Search Top Ranked Law Firm seeks corporate/transactional attorne...

Apply Now

Corporate Attorney / Counsel

USA-NY-New York City

New York City office of a BCG Attorney Search Top Ranked Law Firm seeks corporate attorney with 5+ y...

Apply Now

Housing Finance Associate Attorney

USA-MN-Minneapolis

Minneapolis office of a BCG Attorney Search Top Ranked Law Firm seeks a housing finance associate at...

Apply Now

Most Popular

SEARCH IN ARCHIVE

To Top