FDA Proposes Twitter Guidelines For Prescription Drugs
Tweets would have to include all risks and benefits.
— -- Tweeting about the most commonly prescribed drugs will be nearly impossible if new FDA guidelines on the use of social media by drug and medical device companies are adopted, experts said.
The FDA guidelines, proposed Tuesday by the agency, will require companies to tweet the risks along with the benefits of their products. At minimum, all tweets would have to include the most serious risks associated with a drug including those known to be fatal or life-threatening, and all side effects and warnings printed on the approved product labeling. They would also be obliged to link to a further discussion about the risks and benefits of the drug.
How would Pfizer tweet about the popular erectile dysfunction drug Viagra?
“They wouldn’t be able to do it,” said Thomas Sullivan, editor of the Policy and Medicine blog for Rockpointe, a Maryland-based medical education company.
Viagra, for example, lists nine potentially serious side effects on its label including permanent damage to the penis, loss of sight and loss of hearing. It has nine potentially dangerous interactions with other medications and there are at least 14 health conditions for which its use is not recommended for safety reasons.
“You’re not fitting that into 140 characters,” Sullivan said.
The FDA did offer one sample tweet for the fictional drug NoFocus in its recommendations.
The tweet reads: NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk
Sullivan said it is unusual for the FDA to include a single example within a recommendation and this underscores how challenging social media management has been for the agency. He also noted that the tweet didn't take advantage of common Twitter shorthand like abbreviations and shortened words and it's not clear if the guidelines even permit this.
“The FDA isn’t necessarily up on the realities of social media,” Sullivan said, adding that the agency has offered to allow companies to submit their tweets for approval beforehand.
Sullivan said that Facebook, which has no character limitations, might still be useful for drug sellers looking for some traction on social media. So far the agency has refrained from suggesting regulations for image sharing sites like Pinterest and Instagram, Sullivan said.
If approved, the guidelines will go into effect in 90 days.
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